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Clinical Trials/NCT01358396
NCT01358396
Completed
Not Applicable

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

Cairo University1 site in 1 country52 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Macular Edema
Sponsor
Cairo University
Enrollment
52
Locations
1
Primary Endpoint
Visual Acuity
Status
Completed
Last Updated
14 years ago

Overview

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%.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
October 2010
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: 3 months

Correlate baseline HBA1c to the visual outcomes.

Study Sites (1)

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