Glycemic Control and Diabetic Macular Edema

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Other: Respond to therapy for diabetic macular edema

• Registration Number: NCT01358396
• Lead Sponsor: Cairo University

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 Description

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 Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Primary Completion: 2010-07
• Study Completion: 2010-10
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-20
• Last Update Submitted: 2011-05-20
• Study First Posted: 2011-05-23
• Last Update Posted: 2011-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Central foveal thickness more than 250 microns

Exclusion Criteria

• Proliferative Diabetic Retinopathy.
• Traction Macular Membranes
• Previous Laser or intravitreal injections within 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBA1c	Respond to therapy for diabetic macular edema	-

Primary Outcome Measures

Name	Time	Method
Visual Acuity	3 months	Correlate baseline HBA1c to the visual outcomes.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt