Glycemic Control and Diabetic Macular Edema

NCT ID: NCT01358396

Last Updated: 2011-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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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%.

Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HBA1c

Respond to therapy for diabetic macular edema

Intervention Type OTHER

Correlate HBA1c with visual acuity outcome to therapy.

Interventions

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Respond to therapy for diabetic macular edema

Correlate HBA1c with visual acuity outcome to therapy.

Intervention Type OTHER

Other Intervention Names

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Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Cario University

Locations

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Cairo University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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HB-DME-1

Identifier Type: -

Identifier Source: org_study_id

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