COLLABORATIVE STUDY ON CENTRAL VEIN OCCLUSION

  • Clarkson, John G., (PI)

Project: Research project

Description

This application is for a Reading Center of a national
collaborative randomized controlled clinical trial of
photocoagulation treatment for central vein occlusion. The study
will be conducted at 8 clinical centers with the Reading Center at
the Bascom Palmer Eye Institute (University of Miami), and the
Coordinating Center at Scott and White Hospital in Temple, Texas
(Texas A&M University). Patients will be entered into four study
groups: Non-perfused (Group N); Macular edema (Group M);
Perfused (Group P); and indeterminant (Group I). Eyes in the first
two groups will be randomly assigned to photocoagulation
treatment and a control group. Patients in Groups P and I will be
followed for natural history and for possible later entry into the
randomized study. Estimated recruitment is 240 patients in
Group N; 480 in Group P and 240 in Group I. Approximately 50%
of these patients will also qualify for Group M. Patients will be
recruited for the first 3 years of this 5 year study, and all patients
will be followed until termination of the study. The study is
designed to provide information regarding whether or not
photocoagulation is efficacious in preventing iris
neovascularization and subsequent neovascular glaucoma in eyes
with central vein occlusion and retinal non-perfusion, and whether
or not photocoagulation is useful in preserving visual acuity in
eyes with central vein occlusion and macular edema. Information
collected at base line and each follow-up visit will be forwarded
to the Coordinating Center for processing and analysis.
Photographs taken to record the appearance of the iris and retina,
as well as fluoresein angiographic studies of the retina will be
forwarded to the Reading Center for analysis and interpretation.
The inclusion of patients in the various groups in the study will
depend upon the interpretation of the fluoresein angiogram. The
interpretation of iris photographs will determine the outcome
variable, iris neovascularization. A Data and Safety Monitoring
Committee will review interim results of the study every six
months.
StatusFinished
Effective start/end date3/1/882/28/97

Funding

  • National Institutes of Health: $205,392.00
  • National Institutes of Health
  • National Institutes of Health: $240,728.00
  • National Institutes of Health
  • National Institutes of Health: $210,769.00
  • National Institutes of Health
  • National Institutes of Health

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Veins
Iris
Reading
Macular Edema
Retina
Neovascular Glaucoma
Retinal Vein
Light Coagulation
Natural History
Visual Acuity
Angiography
Randomized Controlled Trials
Safety
Control Groups
Therapeutics

ASJC

  • Medicine(all)