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Clinical Trials/NCT00906659
NCT00906659
Completed
Not Applicable

Correlation of Visual Function, Center Point Thickness and Macular Volume Changes Three Weeks After Focal Photocoagulation for Diabetic Macular Edema

Hospital Juarez de Mexico1 site in 1 country89 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Hospital Juarez de Mexico
Enrollment
89
Locations
1
Primary Endpoint
visual capacity (under subjective refractive correction was measured in decimal equivalent)
Status
Completed
Last Updated
16 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
March 2008
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital Juarez de Mexico

Eligibility Criteria

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

Study Sites (1)

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