Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy
|ClinicalTrials.gov Identifier: NCT00004660|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : May 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Graves' Disease||Radiation: Radiotherapy Radiation: Sham treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Controlled Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy|
|Study Start Date :||June 1993|
|Actual Primary Completion Date :||January 1998|
|Actual Study Completion Date :||January 1998|
|Experimental: Radiotherapy||Radiation: Radiotherapy|
|Sham Comparator: Sham treatment||Radiation: Sham treatment|
- Orbital Volume [ Time Frame: 1 year ]Orbital fat and muscle volumes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004660
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Colum A. Gorman||Mayo Clinic|