Glycemic Control and Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01358396
First received: May 19, 2011
Last updated: May 20, 2011
Last verified: January 2010
  Purpose

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


Condition Intervention Phase
Diabetic Macular Edema
Other: Respond to therapy for diabetic macular edema
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Glycemic Control on Visual and Anatomical Outcomes in Response to Therapy for Diabetic Macular Edema.

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Correlate baseline HBA1c to the visual outcomes.


Enrollment: 52
Study Start Date: January 2010
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HBA1c Other: Respond to therapy for diabetic macular edema
Correlate HBA1c with visual acuity outcome to therapy.
Other Name: Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin

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%.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Diabetic patients with macular edema with central foveal thickness more than 250 microns and no proliferative changes.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358396

Locations
Egypt
Cairo University
Cairo, Egypt, 11431
Sponsors and Collaborators
Cairo University
  More Information

No publications provided

Responsible Party: Tamer A Macky, Cario University
ClinicalTrials.gov Identifier: NCT01358396     History of Changes
Other Study ID Numbers: HB-DME-1
Study First Received: May 19, 2011
Last Updated: May 20, 2011
Health Authority: EGYPT:Faculty of Medicine, Research Committee,Cairo University

Keywords provided by Cairo University:
Diabetic Macular Edema, Glycemic Control

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014