Evaluation and Treatment of Pediatric, Developmental and Genetic Eye Diseases
Data Collection
Eye Diseases
Summary
Study start date: January 14, 2004
Actual date on which the first participant was enrolled.The purpose of this protocol is to allow the pediatric ophthalmology, genetic ophthalmology, and ocular motility specialists at the National Eye Institute to gain additional knowledge of the course of various pediatric, genetic, developmental and ocular motility diseases. Heretofore, this spectrum of diseases will be referred to as pediatric ophthalmology diseases. We wish to evaluate the effects of standard treatments for these diseases, use non- or minimally-invasive technologies to understand the pathogenesis of these diseases, and to collect blood or other easily obtained biologic sample (e.g., urine, saliva, hair, cheek swab, or stool) for future laboratory studies on these diseases. The information gained from 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 patients with a spectrum of these diseases, the protocol will be valuable for the training of pediatric eye disease, ocular genetics, and ocular motility fellows. The pediatric, genetic, and eye movement specialists at the National Eye Institute will choose ophthalmology diseases based on the training and research needs of the NEI program. While the primary focus of this protocol is to study eye disease in children, adults who have a disease that began in childhood or who may have an inherited eye disease or are unaffected first-degree relatives may also be evaluated under this protocol. This protocol is not designed to test any new treatments. Any evaluation of treatments under this protocol will be based on the standard-of-care for each patient's disease. All alternatives for evaluation and care will be reviewed with each patient and the patient's family. Patients in this 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 a new protocol. However, they will not be required to enter any new protocol and their decision to participate will be entirely voluntary.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.350 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* INCLUSION CRITERIA: Subjects will be able to enroll if they: 1. Are a pediatric patient, of any age, with ophthalmic conditions, especially inherited or developmental conditions, OR 2. Are an adult patient with an eye disorder that began in childhood or that is likely to have a genetic/developmental component, OR 3. Are an unaffected first-degree relative that we believe that will aid in our diagnosis or future research objectives, AND 4. Have the ability to understand and sign an informed consent OR have a legal parent/guardian with the ability to do the same. EXCLUSION CRITERIA: Subjects will not be eligible if they: 1. Are unable to follow-up as clinically indicated. 2. Have a severe systemic disease that compromises our ability to provide adequate examination and/or treatment.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United States