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OpenTrials
Completed

NCT Number: NCT01358396

Glycemic Control and Diabetic Macular Edema

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

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Key information

Conditions

Diabetic Macular Edema

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo University

Cairo, Cairo Governorate, 11431, Egypt

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respond to therapy for diabetic macular edema

Other

Correlate HBA1c with visual acuity outcome to therapy.

Other names: Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin

Primary outcomes

  1. Visual Acuity

    Time frame: 3 months

    Correlate baseline HBA1c to the visual outcomes.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 23, 2011
Registry last updated
May 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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