Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-04-18 @ 12:58 PM
Study NCT ID:
NCT02555956
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Grid Laser for Diffuse Diabetic Maculopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-20', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2015-09-20', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of visual acuity after grid laser', 'timeFrame': '6 week', 'description': 'Visual acuity will be mesured pre laser and 06 weeks post laser'}], 'secondaryOutcomes': [{'measure': 'Complication', 'timeFrame': 'during first six weeks after laser', 'description': 'Patiens willbe asked and examined for any potentiail anticipated complication.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Macular grid', 'Subthreshold', 'diabetic macular edema', 'decrease in visual acuity'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'Diabetic related complications are increasing day by day due to increse in the number of diabetic patients all over the world. Diabetic macular edema is one of them and a major cause of vision imparment. Various kind of treatment modalities are preent to treat this coplication. Grid laser is one treatment modality. Laser phtocoagulation is a destrictive procedure.Laser power if kept to aminimum can get the desired results without severe destruction to the retina . In this study, the investigators are going to document the effect of minimal grid laser tn loss o overcome the visioe to diabetic macular edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diabetic patients having diffuse diabetic macular edema.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetic patients with macular edema.\n* both sexes\n* conset to participate.\n\nExclusion Criteria:\n\n* focal edema.\n* patients requiring only the focal laser.\n* patients with proferative diabetic retinopathy.\n* Patients with ischaemic maculopathy on fundus fluorescein angiography.'}, 'identificationModule': {'nctId': 'NCT02555956', 'acronym': 'MMG', 'briefTitle': 'Grid Laser for Diffuse Diabetic Maculopathy', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Subthreshold Double Frequency Nd. YAG Grid Laser for Diffuse Diabetic Maculopathy', 'orgStudyIdInfo': {'id': 'Macular Grid Laser'}}, 'contactsLocationsModule': {'locations': [{'zip': '75500', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dow universty Hospital,Dow international Medical college', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Dr. Jamshed Ahmed, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dow university of health sciences, karachi'}, {'name': 'Jamshed Ahmed, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dow University of Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jamshed Ahmed', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}