Evaluation and Treatment of Pediatric, Developmental and Genetic Eye Diseases
Colección de datos
Enfermedades del Sistema Nervioso Central+16
+ Coloboma
+ Catarata
Resumen
Fecha de inicio: 14 de enero de 2004
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 350 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
* 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.
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
Rocky Mountain Lions Eye Institute
Denver, United StatesAbrir Rocky Mountain Lions Eye Institute en Google MapsNational Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United States