Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT03483402
Status:
COMPLETED
Last Update Posted:
2018-04-04
First Post:
2018-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017889', 'term': 'Exfoliation Syndrome'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-center, one-arm, prospective clinical trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-02', 'studyFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2018-03-23', 'lastUpdatePostDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': '12 months', 'description': 'The change in IOP at 12 months versus baseline and the percentage of patients with ≥20% reduction in IOP.'}], 'secondaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': '1, 3 and 6 months', 'description': 'Change in IOP and the percentage of ≥20% IOP reduction at 1, 3 and 6 months after MLT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pseudoexfoliation Glaucoma', 'Primary Open-angle Glaucoma', 'Micropulse Laser Trabeculoplasty', 'Intraocular Pressure'], 'conditions': ['Pseudoexfoliation Glaucoma', 'Primary Open-angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '30488265', 'type': 'DERIVED', 'citation': 'Makri OE, Pallikari A, Pagoulatos D, Kagkelaris K, Kostopoulou EV, Georgakopoulos CD. Micropulse laser trabeculoplasty on pseuodexfoliation glaucoma patients under topical prostaglandin analogue monotherapy: 1-year results. Graefes Arch Clin Exp Ophthalmol. 2019 Feb;257(2):349-355. doi: 10.1007/s00417-018-4195-2. Epub 2018 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).', 'detailedDescription': 'Patients with PEXG under prostaglandine analogue monotherapy with inadequate IOP control are treated with 360-degrees 532nm MLT.\n\nPatients are evaluated at 1 day, 1 month, 3 months, 6 months and 12 months post-MLT. After trabeculoplasty patients are maintained in treatment with the same drug regimen as pre-MLT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with POAG or PEXG under treatment with glaucoma agents requiring additional reduction of IOP, age older than 18 years, patients willing to provide informed consent to participate in the study and to adhere to the follow-up schedule.\n\nExclusion Criteria:\n\n* pre-existing corneal pathology or scar, history of any previous ocular surgery or any planned ocular surgery during the study, history of prior laser trabeculoplasty, end-stage glaucoma with advanced visual field defect, monocular patients, history of trauma, and concurrent systemic or topical steroid use\n* patients unable to present for follow up'}, 'identificationModule': {'nctId': 'NCT03483402', 'briefTitle': 'Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Study of the Efficacy of a Single Session Micropulse Laser Trabeculoplasty as an Adjunctive Measure in Decreasing Intraocular Pressure in Patients Suffering From Pseudoexfoliation Glaucoma', 'orgStudyIdInfo': {'id': '58/15.02.2018/5103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEXG treated with MLT', 'description': 'Patients with pseudoexfoliation glaucoma (PEXG) under prostaglandine analogue monotherapy with inadequate IOP control treated with 360-degrees 532nm micropulse laser trabeculoplasty (MLT)', 'interventionNames': ['Procedure: Micropulse laser trabeculoplasty']}], 'interventions': [{'name': 'Micropulse laser trabeculoplasty', 'type': 'PROCEDURE', 'otherNames': ['MLT Iridex IQ 532 laser system'], 'description': 'Micropulse laser trabeculoplasty is performed using the Iridex IQ 532 laser system (Iridex Corporation, 1212 Terra Bella Avenue, Mountain View, CA, USA) and 532 nm (green) wavelength MLT is applied with confluent applications to pigmented trabecular meshwork over 360 degrees using a 300 µm spot size, 300 ms duration, 1000 mW power and 15% duty cycle.', 'armGroupLabels': ['PEXG treated with MLT']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Constantine D Georgakopoulos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Patras, Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Ophthalmology', 'investigatorFullName': 'Constantinos D. Georgakopoulos, MD, PhD', 'investigatorAffiliation': 'University Hospital of Patras'}}}}