Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 4:20 AM
Study NCT ID:
NCT03895034
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001035', 'term': 'Aphakia'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jha@rxsight.com', 'phone': '949-521-7870', 'title': 'Jeffrey Ha, Senior Director of Clinical Research', 'organization': 'RxSight'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, an average of 3 months', 'description': 'The at Risk number in All-Cause Mortality represent whole participants while the at Risk number in the Serious and Other (Not Including Serious) Adverse Events tables represent the number of eyes. Non-ocular adverse events were not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Light Adjustable Lens (LAL) and Light Delivery Device (LDD)', 'description': 'Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 66, 'otherNumAffected': 25, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anterior Capsule Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BCDVA Drop of 10 letters of more', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal Guttata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iris Atrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior Capsular Opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Punctate Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision changes including night vision changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}, {'units': 'Eyes', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens (LAL) and Light Delivery Device (LDD)', 'description': 'Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '3 months post op', 'unitOfMeasure': 'Eyes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Light Adjustable Lens (LAL) and Light Delivery Device (LDD)', 'description': 'Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '111', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '109', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'Eyes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}, {'units': 'Eyes', 'counts': [{'value': '111', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Light Adjustable Lens (LAL) and Light Delivery Device (LDD)', 'description': 'Light Adjustable lens (LAL) and Light Delivery Device (LDD): Eligible eyes will receive Light adjustable lens with Light delivery Device treatments'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'spread': '7.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mexico', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Eyes', 'classes': [{'categories': [{'title': 'OD', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'OS', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'Eyes', 'denomUnitsSelected': 'Eyes'}], 'typeUnitsAnalyzed': 'Eyes'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-09', 'size': 2636051, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-04T17:18', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2019-03-27', 'resultsFirstSubmitDate': '2021-08-25', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-25', 'studyFirstPostDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better', 'timeFrame': '3 months post op'}]}, 'oversightModule': {'oversightHasDmc': False, 'isUnapprovedDevice': True}, 'conditionsModule': {'keywords': ['Light Adjustable Lens', 'Intraocular lens', 'LAL'], 'conditions': ['Aphakia', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.\n* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.\n* Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.\n* Willing and able to comply with the requirements for study specific procedures and visits.\n\nExclusion Criteria:\n\n* Study eye with pseudoexfoliation.\n* Study eye with diabetes with any evidence of retinopathy.\n* Study eye with evidence of glaucomatous optic neuropathy.\n* Study eye with history of uveitis.\n* Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless the pterygium did not extend more than 2mm onto the cornea from the limbus.\n* Subjects taking systemic medication that may increase sensitivity to UV light.\n* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.\n* Study eye with history of ocular herpes simplex virus.\n* Study eye with history of a congenital color vision defect'}, 'identificationModule': {'nctId': 'NCT03895034', 'briefTitle': 'Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'RxSight, Inc.'}, 'officialTitle': 'A Single Center Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes', 'orgStudyIdInfo': {'id': 'CSP-032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Light adjustable lens (LAL) and Light Delivery Device (LDD)', 'interventionNames': ['Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)']}], 'interventions': [{'name': 'Light Adjustable lens (LAL) and Light Delivery Device (LDD)', 'type': 'DEVICE', 'description': 'Eligible eyes will receive Light adjustable lens with Light delivery Device treatments', 'armGroupLabels': ['Light adjustable lens (LAL) and Light Delivery Device (LDD)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tijuana', 'country': 'Mexico', 'facility': 'CODET Vision Institute', 'geoPoint': {'lat': 32.5027, 'lon': -117.00371}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RxSight, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}