Glycemic Control and Diabetic Macular Edema
|Diabetic Macular Edema||Other: Respond to therapy for diabetic macular edema||Phase 1|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.|
- Visual Acuity [ Time Frame: 3 months ]Correlate baseline HBA1c to the visual outcomes.
|Study Start Date:||January 2010|
|Study Completion Date:||October 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Other: Respond to therapy for diabetic macular edema
Correlate HBA1c with visual acuity outcome to therapy.
Other Name: Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358396
|Cairo, Egypt, 11431|