Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- visual capacity (under subjective refractive correction was measured in decimal equivalent)
Study Overview
Brief Summary
The purpose of this study is to correlate changes of visual function three weeks after photocoagulation for macular edema, with changes of center point thickness and macular volume.
Detailed Description
Photocoagulation for clinically significant macular edema is effective to reduce the incidence of moderate visual loss. Selective photocoagulation for focal macular edema statistically reduces macular thickening, measured with optical coherence tomography, as early as two weeks after treatment, without significant changes over center point thickness. Although anatomic improvement has been demonstrated with OCT, clinical improvement takes longer to be evident: the Early Treatment Diabetic Retinopathy Study describe that clinical differences in visual function are after the eight month, and all the treatment strategies for macular edema used in this study were associated with an increased rate of moderate visual loss, during the first six weeks. Differences in research can achieve statistical significance, without clinical significance. A study was conducted to identify changes of visual function three weeks after photocoagulation for focal macular edema, and to correlate them with changes of CPT and macular volume, in order to compare the behavior of anatomical changes with visual changes.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •type 2 diabetes
- •regardless of diabetes duration and retinopathy severity level
- •one or both eyes with focal clinically significant macular edema
- •treated with selective or focal photocoagulation
- •visual capacity under subjective refraction before and three weeks after treatment
- •adequate quality 6 mm fast macular map both on the day of photocoagulation, and three weeks after it
Exclusion Criteria
- •patients with myopia over -6.00 diopters
- •any retinal disease different from diabetic retinopathy at the moment of photocoagulation
- •eyes with a thickened posterior vitreous
- •eyes with vitreoretinal traction at the macula
- •if they had required scatter photocoagulation before the three weeks evaluation
Outcomes
Primary Outcomes
visual capacity (under subjective refractive correction was measured in decimal equivalent)
Time Frame: before the treatment and 3 weeks after photocoagulation
center point thickness (measured in µm)
Time Frame: before the treatment and 3 weeks after photocoagulation
macular volume (measured in mm3)
Time Frame: before the treatment and 3 weeks after photocoagulation
Secondary Outcomes
No secondary outcomes reported