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Evaluation and Treatment of Patients With Inherited Eye Diseases

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ClinicalTrials.gov Identifier: NCT00011817
Recruitment Status : Completed
First Posted : March 1, 2001
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date February 28, 2001
First Posted Date March 1, 2001
Last Update Posted Date July 2, 2017
Study Start Date February 21, 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00011817 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation and Treatment of Patients With Inherited Eye Diseases
Official Title Evaluation and Treatment Protocol for Potential Research Subjects With Inherited Ophthalmic Diseases
Brief Summary

This study offers evaluation and treatment for patients with inherited (genetic) eye diseases. 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 (NEI) Institute physicians to increase their knowledge of various genetic eye diseases, identify possible new avenues of research in this area, and maintain their clinical skills; 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.)

Children and adults with genetic eye diseases may be eligible for this study. Candidates will be screened with a medical and family history, thorough eye examination and blood test. The eye examination includes measurements of eye pressure and visual acuity (ability to see the vision chart) and dilation of the pupils with eye drops to examine the lens and retina (back part of the eye). Patients may also undergo additional diagnostic tests needed to determine eligibility for other NEI studies, including routine laboratory testing, imaging, questionnaires, a physical examination, and other standard and specialized tests and procedures as needed. In addition, patients will have special photographs taken of the eye to document the clarity or opacity of the eye lens. They will also undergo a procedure called electroretinography to assess the eye's response to bright lights. For this procedure, the eye is numbed with anesthetic drops and a contact lens is placed in the eye. The patient looks inside a large, hollow sphere and sees flashes of light, first in darkness and then in light. The contact lenses sense small electrical signals generated by the retina.

Patients who need medical care will be given appropriate standard medical treatment. Those who are found eligible for a research study will be recommended for participation in that study and taken off this one.

Participants will be followed at least 3 years. Follow-up visits are scheduled according to the standard of care for the individual patient's eye problem. Patients in this protocol will probably have 1 to 3 follow-up visits per year.

Detailed Description

This "Evaluation and Treatment Protocol" will allow the geneticists and ophthalmic genetic specialists at the NEI to identify, follow and provide "standard of care" treatment to patients with genetic eye disease. The primary purpose of the protocol is to accumulate a cohort of patients with genetic eye disease for possible participation in NEI studies. A secondary purpose is to provide long-term follow-up and treatment for a variety of genetic eye diseases so that the genetic specialists at NEI will be better able to identify research hypotheses about these diseases in addition to maintaining their clinical skills. The availability of cohorts of patients with a spectrum of genetic disorders will be valuable for the training of fellows in ophthalmic genetics, an important mission of the NEI. Finally, the ability to provide long-term follow-up and care will also facilitate referral efforts for new NEI protocols.

The genetic specialists at the National Eye Institute will be free to choose those genetic conditions that interest them. However, the total number of patients that can be enrolled in the protocol will be restricted. 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 genetic condition.

Participants in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new NEI clinical studies 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 protocol and their decision to participate will be entirely voluntary. No more than 150 patients will be accepted in this "Evaluation and Treatment Protocol."

Study Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Hereditary Eye Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†23,¬†2005)
300
Original Enrollment Same as current
Study Completion Date March 31, 2007
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

Patients are initially screened for NEI protocols under the NEI screening protocol or from closeout of another protocol. Some of these patients will have a genetic eye disease that NEI staff wishes to follow and treat. Such patients can then be enrolled in this evaluation and treatment protocol. Each study participant must have the ability to understand and sign an informed consent form.

EXCLUSION CRITERIA:

Patients will be excluded from this study if they are unable or unwilling to give informed consent or they are unwilling to be followed and treated at the NEI clinical center for at least the next 3 years.

Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00011817
Other Study ID Numbers 010102
01-EI-0102
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Eye Institute (NEI)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 31, 2007