Glycemic Control and Diabetic Macular Edema

Cairo University (CU)

Status: Completed

Conditions: Diabetic Macular Edema

Treatments: Other: Respond to therapy for diabetic macular edema

Study type: Observational

Funder types: Other

Identifiers

NCT01358396

HB-DME-1

Details and patient eligibility

About

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

Full 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%.

Enrollment: 52 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

52 participants in 1 patient group

HBA1c

Treatment:

Other: Respond to therapy for diabetic macular edema