Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:38 PM
Study NCT ID:
NCT07434635
Status:
RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APPRAISE: Assessment of Pain and Posterior Synechiae Reduction With Atropine, an Investigation of Post-Surgical Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001285', 'term': 'Atropine'}], 'ancestors': [{'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-05', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score on the Visual Analog Scale (VAS)', 'timeFrame': '1 month', 'description': 'Whether atropine use impacts post-operative pain score on the standard Visual Analog Scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Anterior chamber inflammation (aqueous cell and flare)', 'timeFrame': '1 month', 'description': 'Whether atropine impacts the occurrence of post-operative inflammation, quantified as aqueous cell and flare, using the Standardization of Uveitis Nomenclature (SUN) Criteria'}, {'measure': 'Cystoid macular edema detected by optical coherence tomography', 'timeFrame': '1 month', 'description': 'Whether atropine impacts the occurrence of cystoid macular edema after surgery, detected by optical coherence tomography scanning of the retina'}, {'measure': 'Time to visual recovery', 'timeFrame': '1 month', 'description': 'Whether atropine impacts the time to visual recovery'}, {'measure': 'Intraocular pressure', 'timeFrame': '1 month', 'description': 'Whether atropine impacts intraocular pressure after surgery'}, {'measure': 'Posterior synechiae formation', 'timeFrame': '1 month', 'description': 'Presence or absence of posterior synechiae assessed by slit lamp examination at post-operative visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atropine', 'eye surgery'], 'conditions': ['Eye Disorders']}, 'descriptionModule': {'briefSummary': 'The study will evaluate whether atropine eyedrops are beneficial when used after certain eye surgeries.', 'detailedDescription': 'Atropine eyedrops are often used after certain eye surgeries. This study will compare several outcomes following surgery in patients either using or not using this treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient undergoing vitrectomy surgery\n* able to give informed consent\n\nExclusion Criteria:\n\n* post-operative eyedrop regimens that include topical non steroidal anti-inflammatory medications\n* subjects with altered post-operative eyedrop schedule for enhanced inflammation control\n* documented allergy to atropine'}, 'identificationModule': {'nctId': 'NCT07434635', 'acronym': 'APPRAISE', 'briefTitle': 'APPRAISE: Assessment of Pain and Posterior Synechiae Reduction With Atropine, an Investigation of Post-Surgical Eyes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'APPRAISE: Assessment of Pain and Posterior Synechiae Reduction With Atropine, an Investigation of Post-Surgical Eyes', 'orgStudyIdInfo': {'id': '25-45406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No atropine'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Participant uses atropine eyedrops', 'interventionNames': ['Drug: Atropine 1%']}], 'interventions': [{'name': 'Atropine 1%', 'type': 'DRUG', 'otherNames': ['Atropine'], 'description': 'Subtraction of atropine eyedrops from post-operative treatment regimen', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jay Stewart', 'role': 'CONTACT', 'email': 'eyestudy@ucsf.edu', 'phone': '415-353-9635'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Jay Stewart, MD', 'role': 'CONTACT', 'email': 'eyestudy@ucsf.edu', 'phone': '415-353-9635'}], 'overallOfficials': [{'name': 'Jay Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}