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.
The purpose of this protocol is to allow the pediatric and strabismus specialists at the
National Eye Institute to gain additional knowledge of the course of various pediatric eye
diseases and strabismus and to evaluate the effects of standard treatments for these
diseases. This understanding may lead to ideas for future protocols. This protocol will also
allow for the maintenance of populations of patients with specific pediatric eye diseases
and strabismus that may be eligible for future protocols. In addition, by allowing for the
care of persons with a spectrum of these diseases, the protocol will be valuable for the
training of pediatric eye disease and ocular motility fellows. The pediatric and eye
movement specialists at the National Eye Institute are free to choose those diseases that
interest them.
This protocol is not designed to test any new treatments. Any evaluations or treatment under
this protocol will be based on the current standard of care for each pediatric or ocular
motor disease. All alternatives for evaluation and care will be reviewed with each patient,
and the patient's family.
Patients in this patient evaluation and treatment protocol will be evaluated for potential
eligibility in any new NEI clinical trials or epidemiological protocols as they are
developed. If eligible, patients may be asked to participate in the new protocol. However,
they will not be required to enter any new protocol and their decision to participate will
be entirely voluntary.
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