Glycemic Control and Diabetic Macular Edema
|ClinicalTrials.gov Identifier: NCT01358396|
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : May 23, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Other: Respond to therapy for diabetic macular edema||Phase 1|
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%.
|Study Type :||Observational|
|Actual Enrollment :||52 participants|
|Official Title:||The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.|
|Study Start Date :||January 2010|
|Primary Completion Date :||July 2010|
|Study Completion Date :||October 2010|
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
- Visual Acuity [ Time Frame: 3 months ]Correlate baseline HBA1c to the visual outcomes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358396
|Cairo, Egypt, 11431|