Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT04146961
Status:
COMPLETED
Last Update Posted:
2020-07-30
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-29', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction, measured as the percentage of patients reporting "top box" satisfaction', 'timeFrame': '6/1/20 - 7/1/20', 'description': 'Primary objective: to determine the percentage of patients who report "top box" (5 out of 5) overall satisfaction on the questionnaire instrument. To determine the percentage of patients who report satisfaction ("satisfied" or "very satisfied" as 4 out of 5 on the attached questionnaire instrument.'}], 'secondaryOutcomes': [{'measure': 'Percentage of postoperative patients who report overall satisfaction as either "satisfied" or "very satisfied."', 'timeFrame': '6/1/20 - 7/1/20', 'description': 'To report spectacle independence, measured as the percentage of patients who do not require glasses for each of the common activities queried like driving, reading, computer work, watching TV, and sports/hobbies. To determine the incidence of glare and halos described by the patient as "a fair amount" or worse (Question 20).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'conditions': ['Cataract Surgery']}, 'descriptionModule': {'briefSummary': 'Prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes.', 'detailedDescription': 'This will be an open-label, prospective survey study of patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric intraocular lens in both eyes, comparing to an existing historical dataset of patient reported outcomes with bilateral ReSTOR 3.0 implants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Investigators will collect patient-reported outcomes data on 60 new patients where both eyes receive either a PanOptix or PanOptix Toric lens, depending on the correction needed for each eye to eliminate astigmatism and achieve the target refraction. Both eyes will be targeted for emmetropia. Patients will be screened based on their candidacy for a multifocal implant.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients implanted with the PanOptix or Panoptix Toric lenses bilaterally within 6 months of the survey administration. Patients may have the toric version of this lens in neither eye, one eye, or both eyes.\n* Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.\n* Patients whose spherical equivalent outcome is within 0.5D of target and whose magnitude of manifest postoperative cylinder is less than or equal to 0.75 diopters.\n\nExclusion Criteria:\n\n* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.\n* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered intraocular lens, cystoid macular edema, etc.)\n* Patients with greater than grade 1 posterior capsule opacity.\n* Patient sin the historical reference set who underwent Astigmatic Keratotomy or Limbal Relaxing Incision during cataract surgery. -'}, 'identificationModule': {'nctId': 'NCT04146961', 'briefTitle': 'The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance', 'organization': {'class': 'INDUSTRY', 'fullName': 'Research Insight LLC'}, 'officialTitle': 'The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance', 'orgStudyIdInfo': {'id': 'ALC51819219'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alcon PanOptix or PanOptix Toric IOL', 'type': 'DEVICE', 'description': 'Patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric IOL in both eyes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Harvard Eye Associates', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '34990-1913', 'city': 'Palm City', 'state': 'Florida', 'country': 'United States', 'facility': 'Quentin Allen', 'geoPoint': {'lat': 27.16783, 'lon': -80.26616}}, {'zip': '62025-3886', 'city': 'Edwardsville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Quantum Vision Center', 'geoPoint': {'lat': 38.81144, 'lon': -89.95316}}], 'overallOfficials': [{'name': 'John Hovanesian, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Insight LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Research Insight LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}