Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-26 @ 7:24 AM
Study NCT ID:
NCT05654493
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-01
First Post:
2022-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change In IOP', 'timeFrame': 'Baseline, 12 months post procedure', 'description': 'Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)'}], 'secondaryOutcomes': [{'measure': 'Number of anti-glaucoma medications', 'timeFrame': '12 months', 'description': 'Number of anti-glaucoma medication drops'}, {'measure': 'Change in visual acuity', 'timeFrame': 'Baseline, 12 months post procedure', 'description': 'Change in visual acuity score'}, {'measure': 'Change in cup-disc ratio', 'timeFrame': 'Baseline, 12 months post procedure', 'description': 'Ratio of the size of the optic cup to the optic disc'}, {'measure': 'Change in visual field', 'timeFrame': 'Baseline, 12 months post procedure', 'description': 'Total area visible in peripheral vision when focused on a central point, reported in degrees'}, {'measure': 'Change in iris color', 'timeFrame': 'Baseline, 12 months post procedure', 'description': 'Number of subjects to have a change in their iris color'}, {'measure': 'Complications', 'timeFrame': '12 months', 'description': 'Number of subjects to experience complications from the procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials/cls-20477448', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients.', 'detailedDescription': 'Patients will be submitted to MP-TSCPC throughout the year of 2020, according to parameters determined by the Principal Investigator and executed by the Principal Investigator, after signing the Consent Form and agreeing on having their data used for research purpose. Postsurgical follow up visits will be scheduled for 1 month, 3 months, 6 months and 12 months. Patients IOP, number of medications, visual acuity, visual field, iris color, retinal nerve fiber layer thickness on OCT and any complications (iritis, corneal edema, hyphema, vitreous hemorrhage, vision loss, cataract progression or hypotony maculopathy) will be measured by trained ophthalmic assistants supervised by the Principal Investigator and documented at each visit. Authorized Mayo Clinic personnel will perform chart reviews; using administrative data as designated by Dr. Dorairaj. The data will be statistically analyzed to illustrate the results and determine if the objectives and primary and secondary endpoints were achieved'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnose of glaucoma\n* Indication to be submitted to the procedure\n\nExclusion Criteria:\n\n* Significant thinning of the sclera\n* Current eye infection or inflammation\n* Intraocular surgery performed less than 2 months prior to the enrollment in the study'}, 'identificationModule': {'nctId': 'NCT05654493', 'briefTitle': 'Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '19-008815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '240 Second Group', 'description': 'Receives 240 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps', 'interventionNames': ['Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device']}, {'type': 'EXPERIMENTAL', 'label': '300 Second Group', 'description': 'Receives 300 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 10 sweeps', 'interventionNames': ['Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device']}, {'type': 'EXPERIMENTAL', 'label': '200 Second Group', 'description': 'Receives 200 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps', 'interventionNames': ['Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device']}], 'interventions': [{'name': 'MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device', 'type': 'DEVICE', 'otherNames': ['MP-TLT'], 'description': 'The MicroPulse G-Probe was applied to the superior and inferior hemispheres of the eye under varied treatment times and sweep numbers', 'armGroupLabels': ['200 Second Group', '240 Second Group', '300 Second Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Syril Dorairaj, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Syril K. Dorairaj', 'investigatorAffiliation': 'Mayo Clinic'}}}}