Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-01 @ 2:41 AM
Study NCT ID:
NCT05615805
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-21', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Surface Disease Index', 'timeFrame': '24-72 hours after injection', 'description': 'Patient symptoms questionnaire, range 0-28, higher score is associated with worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Standardized Patient Evaluation of Eye Dryness II', 'timeFrame': '24-72 hours after injection', 'description': 'Patient symptoms questionnaire, range 0-48, higher score is associated with worse outcome.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intravitreal Injection', 'Ocular Rinse', 'Age-Related Macular Degeneration', 'Diabetic Macular Edema', 'Cystoid Macular Edema']}, 'descriptionModule': {'briefSummary': 'This is the first randomized controlled trial looking into post-injection rinse volume of standard ophthalmic eyewash and its affect on patient comfort up to 72 hours after injections.', 'detailedDescription': "Purpose To evaluate whether the volume of wash out rinse after povidone iodine (PI) application for intravitreal injections (IVI) affects patients' ocular surface irritation.\n\nMethods This was a prospective, single-masked, randomized-controlled trial consisting of 142 subjects . A total of 51, 45, and 46 patients received 3-mL, 10-mL, and 15-mL of ocular rinse respectively. Reductions in the Ocular Surface Disease Index (OSDI) and the Standardized Patient Evaluation of Eye Dryness II (SPEED II) surveys, conducted before and at 24-72 hours post-injection, were analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nchoroidal neovascular membrane or cystoid macular edema requiring intravitreal injections for treatment.\n\nExclusion Criteria:\n\nactive ocular infection, eyelid trauma, graft versus host disease, thyroid eye disease, pregnancy.'}, 'identificationModule': {'nctId': 'NCT05615805', 'briefTitle': 'The Effect of Ocular Rinse Volume on Surface Irritation After Intravitreal Injections', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'The Effect of Ocular Rinse Volume on Surface Irritation After Povidone-iodine Preparation for Intravitreal Injections: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB #9810'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3-mL washout with saline based ocular rinse post injection', 'interventionNames': ['Other: OSDI questionnaire', 'Other: SPEEDII questionnaire']}, {'type': 'EXPERIMENTAL', 'label': '10-mL washout with saline based ocular rinse post injection', 'interventionNames': ['Other: OSDI questionnaire', 'Other: SPEEDII questionnaire']}, {'type': 'EXPERIMENTAL', 'label': '15-mL washout with saline based ocular rinse post injection', 'interventionNames': ['Other: OSDI questionnaire', 'Other: SPEEDII questionnaire']}], 'interventions': [{'name': 'OSDI questionnaire', 'type': 'OTHER', 'description': 'Ocular Surface Disease Index', 'armGroupLabels': ['10-mL washout with saline based ocular rinse post injection', '15-mL washout with saline based ocular rinse post injection', '3-mL washout with saline based ocular rinse post injection']}, {'name': 'SPEEDII questionnaire', 'type': 'OTHER', 'description': 'Standardized Patient Evaluation of Eye Dryness II questionnaire', 'armGroupLabels': ['10-mL washout with saline based ocular rinse post injection', '15-mL washout with saline based ocular rinse post injection', '3-mL washout with saline based ocular rinse post injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean McGee Eye Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Depending on their required use of the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}