Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076271
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-01-16
Brief Title:
Evaluation and Treatment of Pediatric Developmental and Genetic Eye Diseases
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation and Treatment of Pediatric Developmental and Genetic Eye Diseases
Status:
COMPLETED
Status Verified Date:
2008-10-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate and treat children or adults with inherited or developmental eye conditions It will allow specialists in pediatric ophthalmology genetic ophthalmology and ocular motility at the National Eye Institute NEI to learn more about the course of various pediatric genetic developmental and eye movement diseases thorough long-term observation and treatment It will also serve as the first step in determining the eligibility of patients who may wish to enroll in other NEI clinical research studies or undergo standard eye treatments
Children with eye conditions especially inherited or developmental conditions and adults with eye disorders that began in childhood or that likely have a genetic or developmental component may be eligible for this study Participants will undergo some or all of the following procedures
Medical history including family history
Physical examination and possibly routine blood tests x-rays tests standard eye movement recordings questionnaires and specialized procedures when needed
Complete eye examination including vision test visual perception eye pressure if possible dilation of the pupils to examine the back of the eye lens vitreous and retina
Photographs of the eyes
Oculography eye movement recordings in patients for whom testing will aid in diagnosis This test is done either with goggles placed over the eyes or with a contact lens placed on each eye When the goggles or lenses are in place the subject looks at a series of red targets on a computer screen
Electroretinography ERG in patients with suspected retinal degeneration This is a test of the electrical function of the eyes Before the test patients sit in a dark room for 30 minutes with their eyes patched A small electrode silver disk is taped to their forehead The eye patches are then removed the eyes are numbed with drops and contact lenses are placed in the eyes The contact lenses sense small electrical signals generated by the retina when lights flash During the ERG recording the patient looks inside a large empty bowl A light flashes first in the dark and then with a light turned on inside the bowl The test takes 1 hour or less
Participants are followed up to 6 times a year for 3 years depending on the diagnosis and treatment
Children with eye conditions especially inherited or developmental conditions and adults with eye disorders that began in childhood or that likely have a genetic or developmental component may be eligible for this study Participants will undergo some or all of the following procedures
Medical history including family history
Physical examination and possibly routine blood tests x-rays tests standard eye movement recordings questionnaires and specialized procedures when needed
Complete eye examination including vision test visual perception eye pressure if possible dilation of the pupils to examine the back of the eye lens vitreous and retina
Photographs of the eyes
Oculography eye movement recordings in patients for whom testing will aid in diagnosis This test is done either with goggles placed over the eyes or with a contact lens placed on each eye When the goggles or lenses are in place the subject looks at a series of red targets on a computer screen
Electroretinography ERG in patients with suspected retinal degeneration This is a test of the electrical function of the eyes Before the test patients sit in a dark room for 30 minutes with their eyes patched A small electrode silver disk is taped to their forehead The eye patches are then removed the eyes are numbed with drops and contact lenses are placed in the eyes The contact lenses sense small electrical signals generated by the retina when lights flash During the ERG recording the patient looks inside a large empty bowl A light flashes first in the dark and then with a light turned on inside the bowl The test takes 1 hour or less
Participants are followed up to 6 times a year for 3 years depending on the diagnosis and treatment
Detailed Description:
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 eg 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 patients disease All alternatives for evaluation and care will be reviewed with each patient and the patients 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
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 patients disease All alternatives for evaluation and care will be reviewed with each patient and the patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-EI-0039 | None | None | None |