Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT04027595
Status:
UNKNOWN
Last Update Posted:
2022-09-01
First Post:
2019-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Outcomes of Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy Performed by Optometrists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-10-04', 'releaseDate': '2022-12-06'}], 'estimatedResultsFirstSubmitDate': '2022-12-06'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2019-07-18', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central Visual Acuity', 'timeFrame': '3 months', 'description': 'Pre and Post Procedure Visual Acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Posterior Capsule Opacification Obscuring Vision']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to formally assess the efficacy and outcomes of optometrist-performed neodymium-doped yttrium aluminum garnet (Nd: YAG) laser capsulotomy procedures.', 'detailedDescription': 'Participants will undergo a pre-procedure examination to establish baseline findings and to determine if they meet the inclusion criteria. Participants will undergo the Nd: YAG laser capsulotomy procedure and will be examined at 1 hour, 1 day (if necessary), 1 week, 1 month, and 3 months following the procedure. Follow-up examinations will evaluate visual acuity improvement and possible post-procedure complications. The complication rate following the laser capsulotomy procedure is typically minimal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Existing patients at primary eye care optometric facilities.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ability to provide written informed consent;\n2. At least 18 years of age, male or female;\n3. Prior cataract surgery;\n4. Diagnosed with posterior capsule opacification obstructing vision;\n5. Best-corrected visual acuity less than 20/40 or visual acuity with glare that reduces by 2 lines or more on an ETDRS visual acuity chart or significant effect on activities of daily living\n\nExclusion Criteria:\n\n1. History of underlying ocular disease (not including mild/moderate non-proliferative diabetic retinopathy or incidental findings)\n2. Previous myopic refractive error greater than 6.00 diopters\n3. Complications following previous ocular procedures (i.e. intraocular lens decentration)\n4. Ocular surgery other than uncomplicated cataract or uncomplicated refractive surgery'}, 'identificationModule': {'nctId': 'NCT04027595', 'briefTitle': 'Efficacy and Outcomes of Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy Performed by Optometrists', 'organization': {'class': 'OTHER', 'fullName': 'Northeastern State University'}, 'officialTitle': 'Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy: Efficacy and Outcomes Performed by Optometrists', 'orgStudyIdInfo': {'id': 'NSUOCO2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy', 'type': 'PROCEDURE', 'description': 'A Nd: YAG laser will be used to open the cloudy posterior capsule of the lens to improve central visual acuity.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '74464', 'city': 'Tahlequah', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Northeastern State University', 'geoPoint': {'lat': 35.91537, 'lon': -94.96996}}], 'overallOfficials': [{'name': 'Nathan Lighthizer, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northeastern State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northeastern State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-12-06', 'type': 'RELEASE'}, {'date': '2023-10-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Northeastern State University'}}}}