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Glycemic Control and Diabetic Macular Edema

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01358396
Enrollment
52
Registered
2011-05-23
Start date
2010-01-31
Completion date
2010-10-31
Last updated
2011-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema, Glycemic Control

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%.

Interventions

OTHERRespond to therapy for diabetic macular edema

Correlate HBA1c with visual acuity outcome to therapy.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual Acuity3 monthsCorrelate baseline HBA1c to the visual outcomes.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026