Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2026-02-08 @ 5:34 AM
Study NCT ID:
NCT03352492
Status:
UNKNOWN
Last Update Posted:
2020-04-14
First Post:
2017-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subject is masked to which eye has the iridotomy at which location'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Paired eye'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-12', 'studyFirstSubmitDate': '2017-11-20', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in visual acuity', 'timeFrame': '30 days post-operative', 'description': 'Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart'}], 'secondaryOutcomes': [{'measure': 'Change in Peli-Robson contrast sensitivity', 'timeFrame': '30 days post-operative', 'description': 'Change from baseline in contrast sensitivity evaluated in number of letters correctly read on the Peli-Robson chart'}, {'measure': 'Change in CSV-1000 contrast sensitivity', 'timeFrame': '30 days post-operative', 'description': 'Change from baseline in contrast sensitivity evaluated using the number of correct responses on the CSV-1000 test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma, Angle-Closure']}, 'descriptionModule': {'briefSummary': 'To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Angle-closure glaucoma\n* Angle-closure glaucoma suspect\n\nExclusion Criteria:\n\n* Monocular status\n* Previous intraocular surgery\n* Visual acuity worse than 20/40\n* Prior episode of acute angle-closure glaucoma\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03352492', 'briefTitle': 'Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function', 'organization': {'class': 'OTHER', 'fullName': 'University of the Incarnate Word'}, 'officialTitle': 'Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function', 'orgStudyIdInfo': {'id': '16-02-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bilateral iridotomy: Superior', 'description': 'Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye.', 'interventionNames': ['Procedure: Superior laser peripheral iridotomy']}, {'type': 'EXPERIMENTAL', 'label': 'Bilateral iridotomy: Temporal', 'description': 'Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye.', 'interventionNames': ['Procedure: Temporal laser peripheral iridotomy']}], 'interventions': [{'name': 'Superior laser peripheral iridotomy', 'type': 'PROCEDURE', 'description': "Iridotomy placement between 11:00 and 1:00 o'clock", 'armGroupLabels': ['Bilateral iridotomy: Superior']}, {'name': 'Temporal laser peripheral iridotomy', 'type': 'PROCEDURE', 'description': "Iridotomy placement at 3:00 or 9:00 o'clock", 'armGroupLabels': ['Bilateral iridotomy: Temporal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana C Hagendorf, PhD', 'role': 'CONTACT', 'email': 'wandless@uiwtx.edu', 'phone': '210-805-3036'}], 'facility': 'University of the Incarnate Word', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Ana Hagendorf, PhD', 'role': 'CONTACT', 'email': 'wandless@uiwtx.edu', 'phone': '210-805-3036'}], 'overallOfficials': [{'name': 'Richard Trevino, OD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of the Incarnate Word'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of the Incarnate Word', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Richard Trevino, OD, FAAO', 'investigatorAffiliation': 'University of the Incarnate Word'}}}}