Diabetic Macular Edema Clinical Trial
Official title:
Comparison of Short-pulse Subthreshold (532 nm) and Infrared Micropulse (810 nm) Macular Laser for Diabetic Macular Edema
Verified date | August 2020 |
Source | Moorfields Eye Hospital Centre Abu Dhabi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
When applied according to manufacturer recommendations, short-pulse system may yield more temporary reduction in edema while infrared micropulse system may yield slightly better functional outcomes.
Status | Completed |
Enrollment | 113 |
Est. completion date | January 1, 2017 |
Est. primary completion date | January 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - center-involving clinically significant macular edema due to diabetic retinopathy (>300 microns) - clear ocular media - ETDRS visual acuity >29 letters (Snellen equivalent of 20/150) or better - treatment naïve eyes or previously treated with antiangiogenic intravitreal agent(s) more than 6 months ago to allow for long wash-out period Exclusion Criteria: - non-center involving diabetic macular edema - previous retinal laser or surgery - intravitreal steroid use - any condition that may be associated with a risk of macular edema such as age-related macular degeneration, retinal vein occlusion, vitreomacular traction, epiretinal membrane and others. |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | Moorfields Eye Hospital Centre | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
Moorfields Eye Hospital Centre Abu Dhabi | King Khaled Eye Specialist Hospital, University of Nebraska |
United Arab Emirates,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Central foveal thickness | All patients had central retinal thickness measurement using spectral-domain optical coherence tomography (SD-OCT)(Spectralis, Heidelberg Engineering, Heidelberg, Germany). The SD-OCT B-scan was based on the Spectralis macular raster consisting of 19 horizontals 6 millimeter line scans and a real-time eye tracking system. | 6 months | |
Primary | Best corrected visual acuity | ETDRS visual acuity charts | 6 months |
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