Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy
OBJECTIVES: I. Evaluate the effects of 20 Gy of external-beam radiotherapy to 1 orbit vs. the untreated orbit at 3 and 6 months after therapy in patients with Graves' ophthalmopathy.
II. Evaluate whether 20 Gy of external-beam radiotherapy delivered to the second orbit 6 months later in the course of the disease produces effects of equal magnitude to those observed when the first orbit was treated.
III. Relate the magnitude of treatment effects to the time since onset of eye symptoms.
IV. Evaluate whether characteristics of radiation retinopathy are present 3 years after orbital radiotherapy.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Controlled Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy|
- Orbital Volume [ Time Frame: 1 year ]Orbital fat and muscle volumes
|Study Start Date:||June 1993|
|Study Completion Date:||January 1998|
|Primary Completion Date:||January 1998 (Final data collection date for primary outcome measure)|
|Experimental: Radiotherapy||Radiation: Radiotherapy|
|Sham Comparator: Sham treatment||Radiation: Sham treatment|
PROTOCOL OUTLINE: The posterior region of 1 orbit is irradiated over 2 weeks with supervoltage equipment. The other orbit is treated 6 months later. The sequence of therapy is randomly assigned.
The untreated eye receives a simultaneous sham treatment during each radiotherapy session.
Patients are followed at 3, 6, 9, 12, and 36 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004660
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Colum A. Gorman||Mayo Clinic|