Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT07295704
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2025-12-06', 'studyFirstSubmitQcDate': '2025-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of best-corrected visual acuity', 'timeFrame': '6 months post-procedure', 'description': 'Change of best-corrected visual acuity will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Change of central macular thickness', 'timeFrame': '6 months post-procedure', 'description': 'Change of central macular thickness will be recorded.'}, {'measure': 'Change of area thickness', 'timeFrame': '6 months post-procedure', 'description': 'Change of area thickness will be recorded.'}, {'measure': 'Change of macular volume', 'timeFrame': '6 months post-procedure', 'description': 'Change of macular volume will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Micropulse Laser', 'Treatment', 'Initial', 'Refractory', 'Center-Involved Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of subthreshold 577 nm micropulse laser photocoagulation in the treatment of initial and refractory cases of Center-Involved Diabetic Macular Edema.', 'detailedDescription': 'Diabetic Retinopathy (DR) is a common and specific microvascular complication of diabetes that affects 17-54% of people with diabetes aged between 49 and 60 years.\n\nDiabetic macular edema (DME) is one of the most common causes of visual loss in today\'s society. It affects about 10% of diabetic individuals and 29% of those who have had the condition for more than 20 years.\n\nIn micropulse mode, the laser emits short pulses, thereby reducing thermal energy in the target area.\n\nThis strategy has two properties: a shorter exposure time and a subvisible clinical endpoint, delivering energy by dividing the beam into a series of short pulses (100-300 µs). Every single pulse has an "on and off" duration (duty cycle (DC)), enabling tissues to cool down before the next pulse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective cohort comparative study was conducted at the Ophthalmology Department of Sohag Teaching Hospital, with approval from the institutional ethical committee.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Both sexes.\n* Patients with type 1 or 2 diabetes mellitus (DM), best-corrected visual acuity (BCVA) of 20/400 or better, and center-involved DME \\[defined as a central macular thickness (CMT) of \\>250 but \\<700µm measured by spectral-domain optical coherence tomography\\].\n* Patients with any level of non-proliferative diabetic retinopathy or proliferative diabetic retinopathy with adequate panretinal photocoagulation (PRP) and no signs of disease activity determined by fluorescein angiography (FA).\n\nExclusion Criteria:\n\n* Monocular eyes.\n* Chronic renal failure or renal transplant because of diabetic nephropathy.\n* Glycated hemoglobin (HbA1c) of more than 10%.\n* Vitreomacular traction syndrome.\n* Epiretinal membrane.\n* PRP within 4months before the treatment.\n* Intraocular surgery within 6months, including cataract or vitreoretinal operation.\n* Rubeosis iridis.\n* Severe glaucoma.\n* High-risk proliferative diabetic retinopathy.\n* Poor dilation.\n* Increased foveal avascular zone.\n* Any condition that could interfere with optical coherence tomography (OCT) measurement or visual acuity.'}, 'identificationModule': {'nctId': 'NCT07295704', 'briefTitle': 'Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema', 'organization': {'class': 'NETWORK', 'fullName': 'The General Authority for Teaching Hospitals and Institutes'}, 'officialTitle': 'Comparative Evaluation of Micropulse Laser in Treatment of Initial and Refractory Cases of Center-Involved Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'HSO00011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Naïve center-involved diabetic macular edema group', 'description': 'Patients with treatment-naïve center-involved diabetic macular edema.', 'interventionNames': ['Other: Micropulse Laser']}, {'label': 'Refractory center-involved diabetic macular edema group', 'description': 'Patients with refractory center-involved diabetic macular edema.', 'interventionNames': ['Other: Micropulse Laser']}], 'interventions': [{'name': 'Micropulse Laser', 'type': 'OTHER', 'description': 'All laser procedures will be performed in a darkened room. The laser will be delivered together in an 8×8 pattern mode with high density (0µm of spacing) over the entire area of macular edema, including the foveal center and unthickened (200µm) retina with no attempt to target or avoid microaneurysms.', 'armGroupLabels': ['Naïve center-involved diabetic macular edema group', 'Refractory center-involved diabetic macular edema group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Hossam A Hassan, MD', 'role': 'CONTACT', 'email': 'Dr.hossameabdalfataah@gothi.gov.eg', 'phone': '00201026808348'}], 'facility': 'the General Authority for Teaching Hospitals and Institutes', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hossam A Hassan, MD', 'role': 'CONTACT', 'email': 'Dr.hossameabdalfataah@gothi.gov.eg', 'phone': '00201026808348'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The General Authority for Teaching Hospitals and Institutes', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow of Ophthalmology, Sohag Teaching Hospital, Egypt.', 'investigatorFullName': 'Hossam Abdelfattah Husein Hassan', 'investigatorAffiliation': 'The General Authority for Teaching Hospitals and Institutes'}}}}