Clinical Trial: Glycemic Control and Diabetic Macular Edema

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.

Brief Summary: Does diabetic patients' glycemic control affect their response to laser and/or intravitreal injection therapy in terms of visual and anatomical outcomes.

Detailed Summary:

To evaluate the visual and anatomical response to therapy in patients with diabetic macular edema (DME) in relation to their glycemic control.

Patients with DME with central foveal thickness (CFT) > 250µm with no proliferative disease had their glycosolated hemoglobin (HbA1c) measured at baseline and 3 months. CFT by optical coherence tomography, and best corrected visual acuity (BCVA) in logMARs were measured at baseline, 1, and 3 months. Exclusion criteria: laser or intravitreal injections within 6 months, hard exudates within 500um of the foveal center, or macular traction. Therapy included laser and intravitreal anti VEGFs. HbA1c graded as: G1=<7%, G2= 7-7.9%, G3= 8-8.9%, G4 = >9%; and as: low <8%, high ≥ 8%.


Sponsor: Cairo University

Current Primary Outcome: Visual Acuity [ Time Frame: 3 months ]

Correlate baseline HBA1c to the visual outcomes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cairo University

Dates:
Date Received: May 19, 2011
Date Started: January 2010
Date Completion:
Last Updated: May 20, 2011
Last Verified: January 2010