Randomized Study of Sequential Orbital Radiotherapy for Graves'

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00004660
Study type	Interventional
Source	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact
Status	Completed
Phase	N/A
Start date	June 1993
Completion date	January 1998

View Details

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Randomized Study of Sequential Orbital Radiotherapy for Graves' Ophthalmopathy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms