Ocular Motility Disorder Clinical Trial
Official title:
Evaluation and Treatment Protocol for Patients With Pediatric Eye Diseases and Strabismus
This study offers evaluation and treatment for patients with pediatric eye diseases,
particularly amblyopia and strabismus. The protocol is not designed to test new treatments;
rather, patients will receive current standard of care treatments. The purpose of the study
is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of
inflammatory eye conditions and identify possible new avenues of research in this area; and
2) to establish a pool of patients who may be eligible for new studies as they are
developed. (Participants in this protocol will not be required to join a new study; the
decision will be voluntary.)
Patients age 6 months and older with pediatric eye diseases, including amblyopia,
strabismus, cataracts, glaucoma, and developmental abnormalities may be eligible for this
study. Candidates will be screened with a medical history, eye examination, and diagnostic
procedures that may include routine laboratory testing, X-rays, questionnaires, physical
examination, and other standard or specialized tests or procedures as needed. The eye
examination includes measurements of eye pressure and visual acuity (ability to see the
vision chart), examination of the pupils and eye movements, and dilation of the pupils to
examine the lens and retina. In addition, patients will undergo a procedure to record eye
movements called oculography, in which special detectors measure infrared light reflected
off the patient's eyes while he or she watches lights on a computer screen.
Participants will be followed for at least 3 years. Visits will be scheduled from 1 to 6
times a year, according to the standard of care for the individual patient's eye problem.
Vision will be checked at each visit, and some of the screening tests described above may be
repeated to follow the progress of disease and evaluate the response to treatment.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | October 2002 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Must have a disorder of ocular motility or a pediatric specific eye disease. Must have the ability to understand and sign an informed consent form or have a legal guardian/parent with the ability to do the same. Patients must have the ability to be followed at the NEI clinical center for at least the next 3 years. Presence of severe systemic diseases such as developmental delay, cancer and others that may compromise the evaluation of the eye disease may exclude patient from this protocol. |
N/A
| Country | Name | City | State |
|---|---|---|---|
| United States | National Eye Institute (NEI) | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Eye Institute (NEI) |
United States,