Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT01496066
Status:
COMPLETED
Last Update Posted:
2018-06-29
First Post:
2011-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism
Sponsor:
Organization:
Raw JSON
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'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal edema central', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'corneal edema wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior capsular opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Raised IOP not requiring treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 32, 'numAffected': 32}, {'groupId': 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'Persistent Induced Tritan Color Anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystoid Macular Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Horseshoe retinal tear with vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypopyon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical complication', 'notes': 'Surgical complication including anterior segment bleeding, vitreous loss, and posterior capsule and zonular rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood clots due to lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken blood vessel in brain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken wrist', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain with pacemaker', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to concussion with subdural hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to emphysema/COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to infection after knee surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to low blood pressure and syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Liver cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant neuroendocrine tumors', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Triple bypass surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Secondary surgical intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phytotoxic retinal damage causing temporary loss of BSCVA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent induced erythropsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Persistent unanticipated increase refractive error', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraoperative capsular tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 403, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Reduction in Manifest Cylinder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens Implanted', 'description': 'Randomized to have the Light Adjustable Lens implanted'}, {'id': 'OG001', 'title': 'Control IOL Implanted', 'description': 'Randomized to have the monofocal control IOL implanted'}], 'classes': [{'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '78.1'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '28.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.', 'unitOfMeasure': 'percent reduction in manifest cylinder', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Only eyes that had cylinder in the range of treatment (\\>=0.75 D) were included in the analysis. Therefore the number of participants analyzed for this outcome measure will not match the overall number of participants in the study.'}, {'type': 'PRIMARY', 'title': 'Percent Absolute Reduction in MRSE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens', 'description': 'Eyes randomized to have Light Adjustable Lens implanted'}, {'id': 'OG001', 'title': 'Monofocal Control IOL', 'description': 'Eyes randomized to have monofocal control IOL implanted'}], 'classes': [{'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '43.8', 'upperLimit': '59.1'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '24.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.', 'unitOfMeasure': 'percentage of reduction in MRSE', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Any eyes that had an MRSE of zero at Pre-Adjustment were excluded since it is not possible to divide by zero. Therefore the number participants analyzed for this outcome will differ from the number of overall participants in the study.'}, {'type': 'PRIMARY', 'title': 'Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens', 'description': 'Eyes randomized to be implanted with the Light Adjustable Lens'}], 'classes': [{'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '97.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.', 'unitOfMeasure': 'percentage of eyes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT: The overall number of participants analyzed differs from the other outcome measures because some photographs were unusable due to inadequate lighting, user error, or equipment failure.'}, {'type': 'SECONDARY', 'title': 'Uncorrected Visual Acuity 20/20 or Better', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens', 'description': 'Randomized to have the Light Adjustable Lens implanted'}, {'id': 'OG001', 'title': 'Monofocal Control IOL', 'description': 'Randomized to have a Monofocal control IOL implanted'}], 'classes': [{'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000'}, {'value': '36.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.', 'unitOfMeasure': 'percentage of eyes', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens', 'description': 'Randomized to have the Light Adjustable Lens implanted'}, {'id': 'OG001', 'title': 'Monofocal Control IOL', 'description': 'Randomized to have the monofocal control IOL implanted'}], 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '57.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.', 'unitOfMeasure': 'percent reduction in cylinder', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with eyes in ITT with 0.75-1.25 D cylinder prior to light treatment'}, {'type': 'SECONDARY', 'title': 'Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens', 'description': 'Randomized to have the Light Adjustable Lens implanted'}, {'id': 'OG001', 'title': 'Monofocal Control IOL', 'description': 'Randomized to have the monofocal control IOL implanted'}], 'classes': [{'categories': [{'measurements': [{'value': '77.5', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '23.1', 'spread': '32.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group.', 'unitOfMeasure': 'percent reduction in cylinder', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with eyes in ITT with \\>1.25 D of cylinder prior to light treatment'}, {'type': 'SECONDARY', 'title': 'Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens', 'description': 'Randomized to have the Light Adjustable Lens implanted'}, {'id': 'OG001', 'title': 'Monofocal Control IOL', 'description': 'Randomized to have the monofocal control IOL implanted'}], 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '76.3', 'groupId': 'OG000'}, {'value': '27.2', 'spread': '75.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.0318', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'For eyes with \\<0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.', 'unitOfMeasure': 'percent absolute reduction in MRSE', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with eyes in ITT with \\<0.75 D of cylinder prior to light treatment'}, {'type': 'SECONDARY', 'title': 'Mean BSCVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '390', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Light Adjustable Lens', 'description': 'Randomized to have the Light Adjustable Lens implanted'}, {'id': 'OG001', 'title': 'Monofocal Control IOL', 'description': 'Randomized to have the Monofocal control IOL implanted'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.066', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-0.029', 'spread': '0.090', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99', 'paramValue': '-0.04', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '-0.02', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'a two-group t-test of equivalence in means was used'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta).', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population best case cohort with no macular problems'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LAL Implant', 'description': 'LAL implanted\n\nLAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD'}, {'id': 'FG001', 'title': 'Monofocal Control', 'description': 'Monofocal control IOL implanted\n\nMonofocal control IOL: Commercially available monofocal intraocular lens (IOL)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '403'}, {'groupId': 'FG001', 'numSubjects': '197'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '391'}, {'groupId': 'FG001', 'numSubjects': '188'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Explant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LAL Implant', 'description': 'LAL implanted\n\nLAL (Light Adjustable Lens) and Light Deliver Device (LDD): LAL implanted and adjusted with LDD'}, {'id': 'BG001', 'title': 'Monofocal Control', 'description': 'Monofocal control IOL implanted\n\nMonofocal control IOL: Commercially available monofocal intraocular lens (IOL)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '7.9', 'groupId': 'BG000'}, {'value': '66.6', 'spread': '7.2', 'groupId': 'BG001'}, {'value': '66.2', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '242', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '385', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '575', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '571', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Right Eye', 'classes': [{'categories': [{'measurements': [{'value': '226', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}, {'title': 'Left Eye', 'classes': [{'categories': [{'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Eyes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 3 medical device study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2011-12-15', 'resultsFirstSubmitDate': '2017-12-29', 'studyFirstSubmitQcDate': '2011-12-20', 'lastUpdatePostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-01', 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Reduction in Manifest Cylinder', 'timeFrame': '6 months', 'description': 'Percent reduction in manifest cylinder from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. Manifest cylinder refers to only the astigmatic or cylindrical component of an ophthalmic manifest refraction. For example if someone had a refraction of +0.50-1.00x090, the -1.00 is the manifest cylinder component. The reduction of the manifest cylinder is determined from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.'}, {'measure': 'Percent Absolute Reduction in MRSE', 'timeFrame': '6 months', 'description': 'Percent absolute reduction in Manifest Refraction Spherical Equivalent (MRSE) from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop. It is used to describe an ophthalmic refraction with one number. It is defined as the (sphere)+ 0.5(cylinder). So, if you had a refraction of +1.00-1.00x090 the MRSE would be +0.50, the +1.00 is the sphere and the -1.00 is the cylinder in this example. If you had a refraction of +0.25-1.50x145 the MRSE would be -0.50. The absolute value of the MRSE is taken and its reduction is calculated from Pre-Adjustment (LAL) or 17-21 days post-op (control) to 6 months postop.'}, {'measure': 'Rotation of LAL Landmark Meridian to Anatomical Landmark at Pre-Adjustment and 6 Months Postop', 'timeFrame': '6 months', 'description': 'Number (%) of eyes with rotation of LAL meridian of ≤ 5 degrees from Pre-Adjustment to 6 months postop. This endpoint was achieved by taking dilated anterior segment photographs of the LAL at Pre-Adjustment and 6 months postop. The angular difference between a landmark on the LAL and an anatomical landmark on the subjects eye was measured. The same landmarks on the LAL and the subjects eye were used at each time point. The angular difference between the two time points was then determined.'}], 'secondaryOutcomes': [{'measure': 'Uncorrected Visual Acuity 20/20 or Better', 'timeFrame': '6 months', 'description': 'Percent of eyes with UCVA of 20/20 or better in the LAL treatment group at 6 months postoperatively was calculated to determine if it is significantly greater than the percent of eyes with UCVA of 20/20 or better in the monofocal control group at 6 months postoperatively.'}, {'measure': 'Mean Reduction in Cylinder by Cylinder Adjustment Stratum (0.75D-1.25D)', 'timeFrame': '6 months', 'description': 'Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group. Results were to be evaluated for each cylinder adjustment stratum (0.75-1.25 D and 1.50-2.00 D) separately.'}, {'measure': 'Mean Reduction in Cylinder by Cylinder Adjustment Stratum (>1.25D)', 'timeFrame': '6 months', 'description': 'Percent reduction in absolute manifest cylinder in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in absolute cylinder in the monofocal control group at 6 months postoperatively compared to Pre-Adjustment in the LAL group/17-21 days postoperative in the control group.'}, {'measure': 'Percent Absolute Reduction in Manifest Refraction Spherical Equivalent (MRSE) for Eyes With <0.75 D Cylinder Postoperatively', 'timeFrame': '6 months', 'description': 'For eyes with \\<0.75 D of cylinder at pre-adjustment (LAL)/17-21 days (control group), percent mean absolute reduction in MRSE by subject in the LAL treatment group was calculated to determine if it is significantly greater than the percent reduction in mean absolute MRSE in the monofocal control group at 6 months postoperatively compared to pre-adjustment in the LAL group/17-21 days postoperative in the control group.'}, {'measure': 'Mean BSCVA', 'timeFrame': '6 months', 'description': 'Mean BSCVA for the "best case" cohort (no macular problems) at 6 months postoperatively was compared between the LAL treatment group and the monofocal control group. Endpoint success was to be achieved if the difference in mean BSCVA between the LAL cohort and the monofocal control group is within 1 line (0.1 LogMAR) (non-inferiority margin or delta).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose is to evaluate the Calhoun Vision Light Adjustable Lens (LAL) and Light Delivery Device (LDD) for reducing astigmatism and improving uncorrected vision after implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing cataract surgery and be willing to have LAL or commercially available IOL implanted\n* Pre-operative regular corneal astigmatism of \\>= 0.75 diopters and \\<= 2.0 diopters\n* Best spectacle corrected visual acuity reduced to 20/40 or worse with or without glare\n* Projected best spectacle corrected visual acuity of 20/20 or better\n* Clear intraocular media other than cataract\n* Potentially good vision in fellow eye\n* Fully dilated pupil of \\>= 7.0 mm\n\nExclusion Criteria:\n\n* Zonular laxity or dehiscence\n* Pseudoexfoliation\n* Age related macular degeneration\n* Retinal degenerative disorder\n* Diabetes with any evidence of retinopathy\n* Glaucomatous optic neuropathy, uveitis, significant anterior segment pathology, keratoconus\n* Corneal dystrophy, previous corneal or intraocular surgery\n* Complications during cataract surgery\n* Serious co-morbid conditions\n* Systemic medications that my increase UV sensitivity\n* Irregular astigmatism'}, 'identificationModule': {'nctId': 'NCT01496066', 'briefTitle': 'Calhoun Vision Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Calhoun Vision, Inc.'}, 'officialTitle': 'A Prospective Randomized Controlled Multi-Center Clinical Study to Evaluate the Safety and Effectiveness of the Light Adjustable Lens (LAL) in Subjects With Pre-Existing Corneal Astigmatism', 'orgStudyIdInfo': {'id': 'CSP-002-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAL', 'description': 'LAL implanted', 'interventionNames': ['Device: LAL (Light Adjustable Lens) and Light Deliver Device (LDD)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monofocal control', 'description': 'Monofocal control IOL implanted', 'interventionNames': ['Device: Monofocal control IOL']}], 'interventions': [{'name': 'LAL (Light Adjustable Lens) and Light Deliver Device (LDD)', 'type': 'DEVICE', 'description': 'LAL implanted and adjusted with LDD', 'armGroupLabels': ['LAL']}, {'name': 'Monofocal control IOL', 'type': 'DEVICE', 'description': 'Commercially available monofocal intraocular lens (IOL)', 'armGroupLabels': ['Monofocal control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jules Stein Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Wolstan & Goldberg Eye Associates', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33870', 'city': 'Sebring', 'state': 'Florida', 'country': 'United States', 'facility': 'Newsom Eye', 'geoPoint': {'lat': 27.49559, 'lon': -81.44091}}, {'zip': '60467', 'city': 'Orland Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Arbor Centers for Eye Care', 'geoPoint': {'lat': 41.63031, 'lon': -87.85394}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eye Surgeons of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Jones Eye Clinic', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '66211', 'city': 'Leawood', 'state': 'Kansas', 'country': 'United States', 'facility': 'Discover Vision & Laser Center', 'geoPoint': {'lat': 38.96667, 'lon': -94.6169}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants, PA', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ophthalmology Consultants, Ltd.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03878', 'city': 'Somersworth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'EyeSight Ophthalmic Services, PA', 'geoPoint': {'lat': 43.26175, 'lon': -70.86534}}, {'zip': '28304', 'city': 'Fayetteville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Vision Center', 'geoPoint': {'lat': 35.05266, 'lon': -78.87836}}, {'zip': '44141', 'city': 'Brecksville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Eye Clinic', 'geoPoint': {'lat': 41.31978, 'lon': -81.62679}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Vance Thompson Vision', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '76051', 'city': 'Grapevine', 'state': 'Texas', 'country': 'United States', 'facility': 'Eye Consultants of Texas', 'geoPoint': {'lat': 32.93429, 'lon': -97.07807}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Focal Point Vision', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84020', 'city': 'Draper', 'state': 'Utah', 'country': 'United States', 'facility': 'Hoopes Vision', 'geoPoint': {'lat': 40.52467, 'lon': -111.86382}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Calhoun Vision, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}