Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-28 @ 8:56 AM
Study NCT ID:
NCT01166568
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2010-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011305', 'term': 'Presbyopia'}, {'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lstewart@refocus-group.com', 'phone': '214-368-0200', 'title': 'Director of Regulatory & Quality', 'phoneExt': '431', 'organization': 'Refocus Group, Inc.'}, 'certainAgreement': {'otherDetails': 'Principal Investigators are NOT employed by the organization sponsoring the study.\n\nThe Sponsor encourages publication and presentation of the safety and efficacy results upon completion of the study. Per the established agreement, the Principal Investigators will work with the Sponsor, in good faith, to ensure all confidential and proprietary information is redacted.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event reporting continued through 24 months.', 'eventGroups': [{'id': 'EG000', 'title': 'PresVIEW Implantation - Single Arm', 'description': '330 nonrandomized subjects entered into a single group arm to receive the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months.', 'otherNumAtRisk': 330, 'otherNumAffected': 143, 'seriousNumAtRisk': 330, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Anterior Eye Structural Change, Deposit and Degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 21}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Eye Disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 47}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Ocular Hemorrhages and Vascular Disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Ocular Infections, Irritations and Inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 70}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Ocular Neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Ocular Neuromuscular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Ocular Sensory Symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Ocular Structural Change, Deposit and Degeneration NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Retina, Choroid and Vitreous Hemorrhages and Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}, {'term': 'Vision Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16'}], 'seriousEvents': [{'term': 'Decreased iris perfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '317', 'groupId': 'OG000'}]}, {'units': 'Primary Eyes', 'counts': [{'value': '317', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects at 11 sites received implantation of the PSI and were followed for 24 months post surgical. As per the protocol, the primary eye is the unit of analysis and was used for primary endpoint analysis. Fellow eyes were followed for safety and summarized separately. The primary eyes of subjects participating in the randomized sub-study were analyzed separately, though, they were also considered part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '288', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000'], 'paramType': 'binomial distribution', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.75', 'ciLowerLimit': '0.75', 'pValueComment': 'the p-value is adjusted for multiple comparisons', 'groupDescription': 'The PSI procedure is defined as successful if 75% of subjects achieve the first primary endpoint or second primary endpoint. The corresponding statistical hypotheses are as follows:\n\nH0 (null hypothesis): p1 ≤ 0.75 Ha (alternative hypothesis): p1 \\> 0.75, Where, p1 is the probability of subjects achieving the first primary endpoint. H0 (null hypothesis): p2 ≤ 0.75 Ha (alternative hypothesis): p2 \\> 0.75, Where, p2 is the probability of subjects achieving the second primary endpoint.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.', 'description': 'Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.', 'unitOfMeasure': 'Primary Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary Eyes', 'denomUnitsSelected': 'Primary Eyes', 'populationDescription': 'Explanted primary eyes were analyzed as failures. Data for primary eyes that missed the 24 month visit, were lost to follow-up, or withdrew consent prior to the 24 month visit were not imputed. Per protocol, primary outcome analysis must be performed on the primary eye only. Fellow eye data is used for safety outcomes and summarized separately.'}, {'type': 'SECONDARY', 'title': 'Presence of Significant Safety Events (SAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}, {'units': 'Primary and Fellow Eyes', 'counts': [{'value': '645', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': "The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.", 'unitOfMeasure': 'Primary and Fellow Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary and Fellow Eyes', 'denomUnitsSelected': 'Primary and Fellow Eyes', 'populationDescription': "All subject eyes implanted with the PSI were included in the safety analysis. The point estimates were calculated for each of the following events at 24 months. Only the incidence of serious adverse events (SAE's) is presented here as only (1) secondary outcome is allowed."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Parameter Point Estimate -- Anterior Segment Ischemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}, {'units': 'Primary and Fellow Eyes', 'counts': [{'value': '645', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.', 'unitOfMeasure': 'Primary and Fellow Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary and Fellow Eyes', 'denomUnitsSelected': 'Primary and Fellow Eyes', 'populationDescription': 'All subject eyes implanted with the PSI were included in the safety analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}, {'units': 'Primary and Fellow Eyes', 'counts': [{'value': '645', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA \\> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.', 'unitOfMeasure': 'Primary and Fellow Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary and Fellow Eyes', 'denomUnitsSelected': 'Primary and Fellow Eyes', 'populationDescription': 'All subject eyes implanted with the PSI were included in the safety analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}, {'units': 'Primary and Fellow Eyes', 'counts': [{'value': '645', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA \\> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.', 'unitOfMeasure': 'Primary and Fellow Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary and Fellow Eyes', 'denomUnitsSelected': 'Primary and Fellow Eyes', 'populationDescription': 'All subject eyes implanted with the PSI were included in the safety analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}, {'units': 'Primary and Fellow Eyes', 'counts': [{'value': '645', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase \\> 10 mmHg) or (IOP \\> 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.', 'unitOfMeasure': 'Primary and Fellow Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary and Fellow Eyes', 'denomUnitsSelected': 'Primary and Fellow Eyes', 'populationDescription': 'All subject eyes implanted with the PSI were included in the safety analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Parameter Point Estimate -- Chronic Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}, {'units': 'Primary and Fellow Eyes', 'counts': [{'value': '645', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.', 'unitOfMeasure': 'Primary and Fellow Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary and Fellow Eyes', 'denomUnitsSelected': 'Primary and Fellow Eyes', 'populationDescription': 'All subject eyes implanted with the PSI were included in the safety analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}, {'units': 'Primary and Fellow Eyes', 'counts': [{'value': '645', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Population', 'description': 'A total of 330 subjects (645 eyes) at 11 sites received implantation of the PSI and were followed for 24 months post surgical. For the safety analysis, subjects participating in the randomized sub-study were analyzed as part of the overall study if they received implantation of the PSI.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase \\>= 0.20) AND (Myopic Shift \\> 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.', 'unitOfMeasure': 'Primary and Fellow Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Primary and Fellow Eyes', 'denomUnitsSelected': 'Primary and Fellow Eyes', 'populationDescription': 'All subject eyes implanted with the PSI were included in the safety analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PresVIEW Implantation - Non-Randomized', 'description': 'Subjects in the non-randomized arm of the study were bilaterally implanted and followed for 24 months. Per the protocol, primary endpoint analysis was performed on the primary eye (only). Fellow eyes were followed for safety and summarized separately'}, {'id': 'FG001', 'title': 'PresVIEW Implantation - Randomized', 'description': 'A randomized sub-study was used to evaluate the early (6 Month) effectiveness of the PresVIEW™ Scleral Implants against a deferred control group (no treatment). Subjects in the randomized sub-study that were randomly assigned to the immediate treatment (surgical) group were bilaterally implanted and followed for 24 months. Pre-operative, 3 month and 6 month post-operative visual acuity for the primary eye was compared to the differed treatment group primary eye visual acuity results. Thirty-two subjects of the total 48 subjects participating in the randomized sub-study, were randomly assigned to receive immediate surgery.'}, {'id': 'FG002', 'title': 'PresVIEW Deferred Implantation - Randomized', 'description': 'Subjects in the randomized sub-study that were randomly assigned to the deferred treatment (control) group were bilaterally implanted after 6 months observation and followed for 24 months post-op. Sixteen subjects of the total 48 subjects participating in the randomized sub-study were randomly assigned to the control group and followed for 6 months prior to surgery (observation). These patients will provide additional informed consent for implantation and their results will be included in the total patient cohort for the PSI SGP-046. Total study participation will be either 6 months (if they did not elect treatment after 6 months observation), or 30 months (6 months observation + 24 months post-operative) if they elected treatment. The observation period included follow-up visits for Day 0 (baseline), 3 months, and 6 months for the randomized sub-study and visual acuity for the primary eye was compared to the immediate treatment group primary eye visual acuity for analysis.'}], 'periods': [{'title': 'Deferred Implantation- Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '32', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'comment': 'From the randomized sub-study control group (n=16), 1 subject withdrew during the observation phase', 'groupId': 'FG002', 'numUnits': '30', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '2', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Implantation- Nonrandomized & Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '562', 'numSubjects': '288'}, {'groupId': 'FG001', 'numUnits': '66', 'numSubjects': '33'}, {'comment': '15 subjects completed the observation phase and 9 subjects (17 eyes) proceeded with implantation.', 'groupId': 'FG002', 'numUnits': '17', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '537', 'numSubjects': '274'}, {'groupId': 'FG001', 'numUnits': '64', 'numSubjects': '32'}, {'comment': '(1) Primary eye implanted only subject withdrew consent after implantation of the device.', 'groupId': 'FG002', 'numUnits': '16', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '25', 'numSubjects': '14'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '1'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'typeUnitsAnalyzed': 'Eye', 'recruitmentDetails': "The prospective, multicenter clinical trial of the PresView Implant was conducted at 14 clinical sites. All recruitment evaluations were performed at the Principal Investigator's sites and subjects were screened for eligibility. If inclusion/exclusion criteria were met, informed consent was obtained and the subject was enrolled in the study.", 'preAssignmentDetails': 'Once determined eligible and informed consent was obtained, both eyes were enrolled in the study. Per protocol, primary outcome analysis must be performed on the primary eye only and the primary eye is therefore the unit of analysis. Fellow eyes were followed for safety outcomes and summarized separately.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '337', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PresVIEW Implantation Non-Randomized', 'description': '288 subjects that received the PresView Scleral Implants, which were surgical placed in the sclera of the eye. Subjects were followed for 24 months. This sample consists of; 16 randomized deferred implantation subjects, 32 randomized implantation subjects, and 282 non-randomized implanted subjects (i.e. all enrolled subjects).'}, {'id': 'BG001', 'title': 'PresVIEW Implantation - Randomized', 'description': '33 randomized subjects entered into a immediate treatment (implantation) group. Subjects were followed for 24 months. Immediate treatment group data was compared to the Deferred Treatment group at 6 months.'}, {'id': 'BG002', 'title': 'PresVIEW Deferred Implantation - Randomized', 'description': '16 randomized subjects entered into a deferred treatment (control) group arm. Subjects were followed for 6 months (observation). Subjects that completed the 6 month observation were then offered PresVIEW implantation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.92', 'spread': '2.90', 'groupId': 'BG000'}, {'value': '54.62', 'spread': '2.96', 'groupId': 'BG001'}, {'value': '55.03', 'spread': '2.66', 'groupId': 'BG002'}, {'value': '54.93', 'spread': '2.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '151', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '186', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '258', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '288', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '337', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'DCNVA 20/40 or Better (at baseline)', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Between 50 to 60 years of age at the commencement of the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A non-randomized arm was run in parallel with a randomized sub-study consisting of 2 arms; Immediate Treatment and Deferred Treatment. Upon completion of the 6 month observation period, the Deferred Treatment group then crosses over upon implantation to become part of the overall study group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2010-07-16', 'resultsFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2010-07-19', 'lastUpdatePostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-31', 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Parameter Point Estimate -- Anterior Segment Ischemia', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Anterior Segment Ischemia at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2% NOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.'}, {'measure': 'Safety Parameter Point Estimate -- Decrease in BCDVA > 2 Lines', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCDVA \\> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.'}, {'measure': 'Safety Parameter Point Estimate -- Decrease in BCNVA > 2 Lines', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Decrease in BCNVA \\> 2 lines at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.'}, {'measure': 'Safety Parameter Point Estimate -- (IOP Increase > 10 mmHg) or (IOP > 25 mmHg)', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis (i.e. both primary and fellow eyes). Point estimates were calculated for the incidence of (IOP Increase \\> 10 mmHg) or (IOP \\> 25 mmHg) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.'}, {'measure': 'Safety Parameter Point Estimate -- Chronic Inflammation', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of Chronic Inflammation at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.'}, {'measure': 'Safety Parameter Point Estimate -- (Axial Length Increase >= 0.20) AND (Myopic Shift > 0.50D MRSE)', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': 'All primary and fellow eyes implanted with the PSI were included in the safety analysis. Point estimates were calculated for the incidence of (Axial Length Increase \\>= 0.20) AND (Myopic Shift \\> 0.50D MRSE) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis.'}], 'primaryOutcomes': [{'measure': 'Number of Primary Eyes With Distance Corrected Near Visual Acuity (DCNVA) to 20/40 or Better or Improvement of 2 or More Lines', 'timeFrame': 'From date of baseline measurement until the date of study withdrawal or study completion, whichever came first, assessed up to 2 years.', 'description': 'Measurement of the Distance Corrected Near Visual Acuity at 40 centimeters achieving 20/40 or better or improvement of 2 or more lines at 24 months for the primary eye.'}], 'secondaryOutcomes': [{'measure': 'Presence of Significant Safety Events (SAEs).', 'timeFrame': 'From initiation of the implantation procedure (operative day) until study completion at 24 months or withdrawal from the study.', 'description': "The point estimate were calculated for clinically significant adverse events (SAE's) at the end of the study. Incidence of adverse event totals should not to exceed 5%, and the incidence of each event should not exceed 1-2%.\n\nNOTE: Because the secondary outcome is a safety measure, both primary and fellow eyes were used for analysis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Presbyopia', 'Reading Vision', 'Near Vision'], 'conditions': ['Presbyopia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov', 'label': 'US Food and Drug Administration Website'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and effectiveness of the PresVIEW™ Scleral Implant (PSI) for the improvement of near visual acuity in presbyopic patients.', 'detailedDescription': 'The clinical investigation of the PresView™ Scleral Implant (PSI) is a prospective multicenter clinical trial in which a total of 330 subjects were enrolled and implanted with the PSI and followed for a period of 24 months at up to 14 clinical sites.\n\nAn additional randomized sub-study was performed on 48 subjects with the PSI Second Generation PresView™(SGP) implant, model number SGP-046. A 2:1 randomization was used to determine the 32 subjects assigned to be implanted and the 16 subjects assigned to the observation/deferred implantation control arm. Subjects randomized to the deferred implantation control arm were eligible to receive the PSI after completion of the 6 months of observation in the study.\n\nAll subjects interested in participating in the study were screened for eligibility, and informed consent was obtained from those who meet the inclusion/exclusion criteria. Eligible subjects were examined preoperatively to obtain a medical history and baseline ocular data.\n\nEffectiveness: The following tests/measurements used to evaluate the effectiveness of the PSI procedure will be included in the study protocol:\n\n* Near visual acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)\n* Reading acuity of the operated eye/eyes as compared with baseline (uncorrected and distance corrected)\n\nThe PSI procedure will be defined as successful if a logMar equivalent to Snellen 20/40 or better (logMar 0.3) is achieved in ≥ 75% of patients or if 75% of patients realize an improvement ≥ 2 lines in distance corrected near visual acuity (DCNVA). For most patients, this will translate into the ability to read the majority of newspaper and magazine print without a near optical aid.\n\nSafety: Primary safety outcomes for safety will include:\n\n* Incidence of anterior segment ischemia\n* Decrease in Best Corrected Distance Visual Acuity (BCDVA) of more than 2 lines from baseline at 1-month or more postoperatively\n* Decrease in best distance corrected near acuity (with add) of more than 2 lines from baseline at 1-month or more postoperatively\n* Intraocular Pressure (IOP) increase \\> 10mm Hg over baseline or IOP \\> 25mm Hg after 1 Day postoperative\n* Signs of chronic inflammation (e.g. uveitis or chronic conjunctival hyperemia) at 2 months or more postoperatively\n* Increase in axial length of ≥ 0.20mm accompanied by a \\> 0.5 diopter myopic shift in manifest spherical equivalent distance refraction.\n* Incidence of adverse events: total not to exceed 5%, and the incidence of each event should not exceed 1-2%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be between 50-60 years old\n* Subject must have a best corrected distance visual acuity of 20/20 or better\n* Subject must have SLOAN distance corrected near visual acuity @ 40cm in the operative eye/eyes of 20/50 to 20/100 (inclusive).\n* Subject should have a manifest distance spherical equivalent refractive correction in the operative eye/eyes of from -0.50 to +0.75 diopters with no more than 1.00 diopter of astigmatism and should require at least a +1.50 diopter add. The distance manifest refraction spherical equivalent and the distance cycloplegic refraction spherical equivalent must be within 0.50 diopters of each other.\n* Subject must be phakic in the study eye\n* Subject must be mentally competent to understand and comply with the requirements of the study.\n* Subject must be able to provide written informed consent.\n\nExclusion Criteria:\n\n* Chronic uveitis or other recurrent anterior or posterior segment inflammation in either eye.\n* Scleral thickness less than 530 μm in the operative eye/eyes.\n* Any previous eye surgeries including cataract, LASIK, or Muscle surgery\n* Any history of prior extraocular muscle surgery, specifically the recti or oblique muscles.\n* Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc.\n* Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases\n* Allergic to any medications used in the study.\n* The patient may not have participated in a device clinical study for the operative eye within the last 3 months and may not have been implanted with PSI devices in this or any other study.'}, 'identificationModule': {'nctId': 'NCT01166568', 'briefTitle': 'Trial of the PresVIEW Implant for the Improvement of Near Vision in Patients With Presbyopia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Refocus Group, Inc.'}, 'officialTitle': 'A Prospective, Multicenter Clinical Trial Of the PresVIEW Scleral Implant (PSI) For the Improvement Of Near Visual Acuity In Presbyopic Patients', 'orgStudyIdInfo': {'id': 'P-277-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implantation-Non Randomized', 'description': 'Subjects are not participants in the randomized sub-study. PresView Scleral Implants surgical placed in the eye(s) after enrollment and meeting inclusion/exclusion criteria.', 'interventionNames': ['Device: PresVIEW Scleral Implants']}, {'type': 'EXPERIMENTAL', 'label': 'Implantation-Randomized', 'description': 'Subjects are participants in the randomized sub-study. Subjects were randomized to the Immediate Treatment group. PresView Scleral Implants surgical placed in the eye(s)Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria.', 'interventionNames': ['Device: PresVIEW Scleral Implants']}, {'type': 'NO_INTERVENTION', 'label': 'Deferred Implantation-Randomized', 'description': 'Subjects are participants in the randomized sub-study after enrollment and meeting inclusion/exclusion criteria. Subjects were randomized to the Deferred Treatment group are observed for 6 months. Upon completion of the observation follow-up, subjects can opt to have PresView Scleral Implants surgically placed in the eye(s) and become part of the overall study experimental group.'}], 'interventions': [{'name': 'PresVIEW Scleral Implants', 'type': 'DEVICE', 'description': 'Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.', 'armGroupLabels': ['Implantation-Non Randomized', 'Implantation-Randomized']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Boxer-Wachler Vision Institute', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92122', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Gordon-Weiss-Schanzlin Vision Institute', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60016', 'city': 'Des Plaines', 'state': 'Illinois', 'country': 'United States', 'facility': 'The Midwest Center for Sight', 'geoPoint': {'lat': 42.03336, 'lon': -87.8834}}, {'zip': '60046', 'city': 'Lake Villa', 'state': 'Illinois', 'country': 'United States', 'facility': 'Jacksoneye', 'geoPoint': {'lat': 42.41697, 'lon': -88.07397}}, {'zip': '60148', 'city': 'Lombard', 'state': 'Illinois', 'country': 'United States', 'facility': 'Vision/Advanced Eye Center', 'geoPoint': {'lat': 41.88003, 'lon': -88.00784}}, {'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Eye Care Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48034', 'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Associated Vision Consultants', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'zip': '68144', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Cornea Associates', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14228', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Fichte, Endl and Elmer Eyecare Creekside Center', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '27410', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Southeastern Eye Center', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '74133', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Eye Associates of South Tulsa', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Wang Vision Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78212', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Braverman-Terry-Oei-Eye Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The Center for Corrective Eye Surgery', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'David Schanzlin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Medical Officer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Refocus Group, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}