Evaluation and Treatment of Patients With Corneal and External Diseases
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2001 |
| End Date: | March 2009 |
Evaluation and Treatment of Corneal and External Diseases and Anterior Segment Disorders
This study offers evaluation and treatment for patients with certain corneal and external
diseases of the eye (diseases of the surface of the eye and its surrounding structures). 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 various corneal and external 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.)
Children and adults with corneal or external eye diseases may be eligible for this study.
Candidates will be screened with a medical history, brief physical examination, 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 to examine the
lens and retina (back part of the eye). Patients will also undergo the following procedures:
1. Eye photography - Special photographs of the inside of the eye to help evaluate the
status of the cornea and conjunctiva (the most superficial layer of the eye) evaluate
changes that may occur in the future. From two to 20 pictures may be taken, depending
on the eye condition. The camera flashes a bright light into the eye for each picture.
2. Conjunctival or lacrimal gland biopsy - A small piece of the conjunctiva or the
lacrimal (tear) gland, is removed for examination under the microscope. Anesthetic
drops and possibly an injection of anesthetic are given to numb the eye. An antibiotic
ointment and patch may be placed over the eye for several hours after the procedure.
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. Vision will be checked at
each visit, and some of the tests described above may be repeated to follow the progress of
disease and evaluate the response to any treatment that is given.
diseases of the eye (diseases of the surface of the eye and its surrounding structures). 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 various corneal and external 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.)
Children and adults with corneal or external eye diseases may be eligible for this study.
Candidates will be screened with a medical history, brief physical examination, 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 to examine the
lens and retina (back part of the eye). Patients will also undergo the following procedures:
1. Eye photography - Special photographs of the inside of the eye to help evaluate the
status of the cornea and conjunctiva (the most superficial layer of the eye) evaluate
changes that may occur in the future. From two to 20 pictures may be taken, depending
on the eye condition. The camera flashes a bright light into the eye for each picture.
2. Conjunctival or lacrimal gland biopsy - A small piece of the conjunctiva or the
lacrimal (tear) gland, is removed for examination under the microscope. Anesthetic
drops and possibly an injection of anesthetic are given to numb the eye. An antibiotic
ointment and patch may be placed over the eye for several hours after the procedure.
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. Vision will be checked at
each visit, and some of the tests described above may be repeated to follow the progress of
disease and evaluate the response to any treatment that is given.
This protocol will permit the specialists in cornea and external disease at the NEI to
identify, follow and provide "standard of care" treatment to patients with various corneal
and external disease and anterior segment disorders. By providing long-term follow-up and
treatment for a variety of corneal and external diseases, the corneal specialists at NEI
will be better able to identify research hypotheses about these diseases in addition to
maintaining their clinical skills. Another purpose of the protocol is to accumulate a cohort
of patients with corneal diseases for possible participation in new NEI clinical trials and
epidemiological protocols. The availability of cohorts of patients with a spectrum of
anterior segment diseases will be valuable for the training of fellows, an important
component of the mission of the NEI. The ability to provide follow-up and care will also
facilitate referral efforts for NEI protocols.
The cornea specialists at the National Eye Institute will be free to choose those 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
as appropriate for the relevant ocular disease.
Participants in this evaluation and treatment protocol will be evaluated for potential
eligibility in other NEI clinical trials or epidemiologic protocols as they are developed.
If eligible, they 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.
identify, follow and provide "standard of care" treatment to patients with various corneal
and external disease and anterior segment disorders. By providing long-term follow-up and
treatment for a variety of corneal and external diseases, the corneal specialists at NEI
will be better able to identify research hypotheses about these diseases in addition to
maintaining their clinical skills. Another purpose of the protocol is to accumulate a cohort
of patients with corneal diseases for possible participation in new NEI clinical trials and
epidemiological protocols. The availability of cohorts of patients with a spectrum of
anterior segment diseases will be valuable for the training of fellows, an important
component of the mission of the NEI. The ability to provide follow-up and care will also
facilitate referral efforts for NEI protocols.
The cornea specialists at the National Eye Institute will be free to choose those 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
as appropriate for the relevant ocular disease.
Participants in this evaluation and treatment protocol will be evaluated for potential
eligibility in other NEI clinical trials or epidemiologic protocols as they are developed.
If eligible, they 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.
- INCLUSION CRITERIA:
1. Corneal and external diseases or anterior segment disorders.
2. If adult, ability to provide informed consent. Cognitively impaired adults will
not be enrolled.
3. Infants under the age of 2 years are excluded. Children greater than or equal to
age of 2 years willing to provide assent who meet other study requirements are
eligible to participate.
EXCLUSION CRITERIA:
Subjects may be excluded if they
1. Are unwilling or unable to cooperate with study procedures.
2. Have any disease or condition with less than 3 year expected survival.
3. There are no medical exclusions.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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