Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02875158
Status:
COMPLETED
Last Update Posted:
2023-09-11
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cyclophotocoagulation in Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure (IOP) evolution', 'timeFrame': '1h, 1 month, 6 months, 12 months, 18 months and 24 months post-op', 'description': 'The intraocular pressure is measured to determine the efficacy of treatment during follow-up compared to the baseline IOP.'}], 'secondaryOutcomes': [{'measure': 'Presence of complications', 'timeFrame': 'During the intervention, 1 month, 6 months, 12 months, 18 months, 24 months post-op', 'description': 'Assessment of complications (if applicable).'}, {'measure': 'Use of medication', 'timeFrame': '1 month, 6 months, 12 months, 18 months and 24 months post-op', 'description': 'Assessment of the topical and oral glaucoma medication at baseline and after treatment'}, {'measure': 'Retreatment', 'timeFrame': 'From the initial treatment up to the last visit (24 months)', 'description': 'The clinician will assess the need for retreatment based on clinical experience.'}, {'measure': 'Visual acuity', 'timeFrame': '1 month, 6 months, 12 months, 18 months and 24 months post-op', 'description': 'The visual acuity will be assessed at baseline and each subsequent visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Transscleral cyclophotocoagulation of the ciliary body is an effective technique to reduce intraocular pressure in case of glaucoma. Due to concerns over complications, the main indications for this second-line treatment are refractory glaucoma medication / surgery and low visual prognosis. The 2000 milliwatts (mW) for 2 seconds settings are used by the majority of researchers and clinicians according to the published literature. Some have proposed using 1250 mW for 4 seconds to improve the use of this medical procedure.\n\nThe aim of this study is to determine how different parameters affect the efficacy of the treatment. This is a prospective double-blinded randomized controlled trial comparing two groups, the experimental group using 1250 mW for 4 seconds and the control group using 2000 mW for 2 seconds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with poorly controlled high pressure glaucoma\n* Cyclophotocoagulation necessary to prevent visual loss\n* Cyclophotocoagulation necessary to prevent or to reduce ocular discomfort\n\nExclusion Criteria:\n\n* Patient has already undergone a cyclophotocoagulation or cryotherapy treatment in the same eye for glaucoma\n* Patients receiving concomitant treatment the same day as the intervention\n* Patient not able to follow the prescribed post-operative treatment'}, 'identificationModule': {'nctId': 'NCT02875158', 'briefTitle': 'Cyclophotocoagulation in Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Modified Settings for Transscleral Cyclophotocoagulation of the Ciliary Body in Glaucoma : A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2015-2212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Diode laser using conventional settings', 'description': 'The cyclophotocoagulation protocol is used with the conventional cyclophotocoagulation settings of 2000 mW for 2 seconds.', 'interventionNames': ['Procedure: Cyclophotocoagulation protocol', 'Procedure: Conventional cyclophotocoagulation']}, {'type': 'EXPERIMENTAL', 'label': 'Diode laser using modified settings', 'description': 'The cyclophotocoagulation protocol is used with the modified cyclophotocoagulation settings of 1250 mW for 4 seconds.', 'interventionNames': ['Procedure: Cyclophotocoagulation protocol', 'Procedure: Modified cyclophotocoagulation']}], 'interventions': [{'name': 'Cyclophotocoagulation protocol', 'type': 'PROCEDURE', 'description': '* Intravenous route is installed\n* Retrobulbar anaesthesia : 50% xylocaine (2%) + 50% bupivicaine\n* Parameters set for laser treatment (1250mW-4seconds or 2000mW-2 seconds depending on the assigned group)\n* Pars plana measurement using transillumination (if needed)\n* Laser treatment applied approximately 1mm post to limbus\n* Dexamethasone 0,5 mg subconjunctival injection\n* Post-op regimen: Prednisolone 1% qid x 4 weeks, Atropine 1% bid x 2 weeks + Erythromycin ointment + patch x 6h', 'armGroupLabels': ['Diode laser using conventional settings', 'Diode laser using modified settings']}, {'name': 'Conventional cyclophotocoagulation', 'type': 'PROCEDURE', 'description': '1250 mW for 4 seconds.', 'armGroupLabels': ['Diode laser using conventional settings']}, {'name': 'Modified cyclophotocoagulation', 'type': 'PROCEDURE', 'description': '2000 mW for 2 seconds.', 'armGroupLabels': ['Diode laser using modified settings']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1S 4L8', 'city': 'Québec', 'country': 'Canada', 'facility': "Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement. CHU de Québec", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Andrew Toren, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche du CHU de Québec : Université Laval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}