NIH Clinical Research Studies

Protocol Number: 03-EI-0291

Active Followup, Protocols NOT Recruiting New Patients

Title:
A Pilot Study of Laser Photocoagulation for Diabetic Macular Edema
Number:
03-EI-0291
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.

Sponsoring Institute:
National Eye Institute (NEI)
Recruitment Detail
Type: Follow-up Of Previously Enrolled Subjects Only
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
Special Instructions: Currently Not Provided
Disease Category:
PROTICD
Keywords:
Grid Laser
Focal Laser
Glycemic Control
Recruitment Keywords:
Diabetes
Diabetic Macular Edema
Macular Edema
Conditions:
Diabetic Retinopathy
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citations:
[No authors listed] Early Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS reportnumber 7.Ophthalmology. 1991 May;98(5 Suppl):741-56. PMID: 2062510

[No authors listed] Grading diabetic retinopathy from stereoscopic color fundus photographs--an extension of themodified Airlie House classification. ETDRS report number 10.Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):786-806. PMID: 2062513

[No authors listed] Photocoagulation for diabetic macular edema. Early Treatment DiabeticRetinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group.Arch Ophthalmol. 1985 Dec;103(12):1796-806. PMID: 2866759

Active Followup, Protocols NOT Recruiting New Patients

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