Pilot Study of Laser Photocoagulation Therapy for Diabetic Macular Edema

NCT00069056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina, a thin layer of tissue that lines the back of the eye, become leaky and the retina swells. The macula, the center part of the retina that is responsible for fine vision, may also swell and cause vision loss. Traditional laser treatment (argon blue or green, or yellow) for macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision. A different laser technique, the mild macular grid, uses lighter laser burns through the macula and may be less damaging to the eye, but this is not known. This study will compare the two techniques and the information on side effects will be used to design a larger study of whether one laser is more effective than the other.

Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be eligible for this study. Candidates will be screened with the following tests and procedures:

* Medical history and physical examination.
* Eye examination to assess visual acuity (eye chart test) and eye pressure, and to examine pupils, lens, retina and eye movements. The pupils will be dilated with drops for this examination.
* Blood tests to measure cholesterol levels, hemoglobin A1C (a measure of diabetes control), and creatinine (measure of kidney function).
* Eye photography to help evaluate the status of the retina and changes that may occur in the future. Special photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye.
* Fluorescein angiography to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.
* Optical coherence tomography to examine retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. These measurements will be repeated during the study to determine whether retinal thickening is getting better, worse, or staying the same.

Participants will be randomly assigned to one of the two laser therapies in the eye with macula edema. (Patients with macular edema in both eyes will receive both treatments-one in each eye.) For these procedures, eye drops are put in the eye to numb the surface, and a contact lens is placed on the eye during the laser beam application. Several visits may be required for additional laser treatments. The number of treatments depends on how well they are working. Patients will return for follow-up visits 4, 8, and 12 months after the first treatment, and then every year until year 3. During the follow-up visits, the response to treatment will be evaluated with repeat tests of several of the screening exams.

Conditions

Diabetic Retinopathy

Interventions

PROCEDURE: Laser Treatment

Sponsors & Collaborators

National Eye Institute (NEI)
lead NIH

Study Design

Purpose: TREATMENT

Eligibility

Min Age: 18 Years
Sex: ALL
Healthy Volunteers: No

Timeline & Regulatory

Start: 2003-09-10
Completion: 2007-08-15

Countries

United States

Study Locations

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Entities

Diseases

Diabetic Retinopathy