Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006422
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-10-27
Brief Title:
Evaluation and Treatment of Pediatric Eye Diseases
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation and Treatment Protocol for Patients With Pediatric Eye Diseases and Strabismus
Status:
COMPLETED
Status Verified Date:
2002-10
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 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 patients 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 patients 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
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 patients 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 patients 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
Detailed Description:
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 patients 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
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 patients 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
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 |
|---|---|---|---|
| 01-EI-0023 | None | None | None |