Eye DiseasesNCT00088348
Screening for Research Subjects With Anterior Segment Diseases
An observational study of Eye Diseases, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will identify patients with anterior segment disease who may be eligible to participate in current or future NEI studies on this disease. Anterior segment disease includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body and lens of the eye. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Diseases
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2004to 20 Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- ELIGIBILITY CRITERIA:
To participate in this screening study, a patient must have a history of anterior segment disease. Patients of all ages are eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Anterior Segment Disease
This study will identify patients with anterior segment disease who may be eligible to participate in current or future NEI studies on this disease. Anterior segment disease includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body and lens of the eye. The eye surface is composed of the cornea, conjunctiva, eyelids, lacrimal and meibomian glands, and the interconnecting nerves.
Patients of any age with anterior segment disease may be eligible for this screening study. Participants will be evaluated with some or all of the following tests and procedures, depending on the nature of their eye problem:
Read more
- Medical history and brief physical examination.
- Eye examination, including measurement of visual acuity (eye chart) and eye pressure, examination of the pupils, eye movements, structures in the front of the eye (cornea, conjunctive, etc.), the lens, and the structures in the back of the eye (retinal, optic nerve, etc.).
- Photographs of the eye to help assess the status of the cornea and conjunctive and to evaluate any changes that may occur in the future.
- Assessment of tear and surface status. The amount of tears the eyes can produce is measured by placing a small piece of sterile paper in the corner of the eye every 5 minutes. Special orange and green dyes are placed in the eyes to determine the health status of the surface of the eye.
- Corneal or conjunctival biopsy. A small tissue sample from the surface of the eye may be removed for laboratory examination to help diagnose a condition that is unclear. For this procedure, the eye is numbed with anesthetic eye drops. The required tissue is collected, an antibiotic ointment is placed in the eye to prevent infection, and a patch may be placed over the eye for 12 to 24 hours.
- Blood draw for tests to study the cause of the patient's eye disease.
- Other diagnostic tests as needed.
- DNA testing to look for a genetic pattern associated with the patient's eye disease.
Patients who are found eligible for an NEI study will be offered participation in that study. Patients who are not eligible for current studies will be advised about treatment options.
Read the detailed description
This is a screening protocol that will allow the NEI clinicians to examine patients with ocular diseases in order to identify those who may be eligible to participate in other NEI studies on anterior segment disease.
- Conditions
- Eye Diseases
- Keywords
- Cornea, Conjunctiva, Keratitis, Ocular Surface, Inflammation, Evaluation, Screening, Ocular Surface Disease, Eye, Ocular Disease, Anterior Segment Disease
- Medical subject headings
- Eye Diseases, Corneal Diseases, Keratitis, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2004 (estimated)
- Study start13 Jul 2004
- Study completion20 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088348
- Sponsor's protocol ID
- 040241
- Other IDs
- 04-EI-0241
- Status last verified
- 20 Aug 2008
- First submitted
- 23 Jul 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Holland EJ. Epithelial transplantation for the management of severe ocular surface disease. Trans Am Ophthalmol Soc. 1996;94:677-743.
PubMed 8981714
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Study for the Evaluation and Diagnosis of Potential Research Subjects With Anterior Segment Disease
- ClinicalTrials.gov ID
- NCT00088348
- Acronym / sponsor ID
- 040241
- Conditions
- Eye Diseases
- Keywords
- Cornea, Conjunctiva, Keratitis, Ocular Surface, Inflammation, Evaluation, Screening, Ocular Surface Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 13 Jul 2004
- Study completion
- 20 Aug 2008
- First posted
- 26 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will identify patients with anterior segment disease who may be eligible to participate in current or future NEI studies on this disease. Anterior segment disease includes all disorders that affect the eye surface, anterior chamber, iris and ciliary body and lens of the eye. The eye surface is composed of the cornea, conjunctiva, eyelids, lacrimal and meibomian glands, and the interconnecting nerves.
Patients of any age with anterior segment disease may be eligible for this screening study. Participants will be evaluated with some or all of the following tests and procedures, depending on the nature of their eye problem:
- Medical history and brief physical examination.
- Eye examination, including measurement of visual acuity (eye chart) and eye pressure, examination of the pupils, eye movements, structures in the front of the eye (cornea, conjunctive, etc.), the lens, and the structures in the back of the eye (retinal, optic nerve, etc.).
- Photographs of the eye to help assess the status of the cornea and conjunctive and to evaluate any changes that may occur in the future.
- Assessment of tear and surface status. The amount of tears the eyes can produce is measured by placing a small piece of sterile paper in the corner of the eye every 5 minutes. Special orange and green dyes are placed in the eyes to determine the health status of the surface of the eye.
- Corneal or conjunctival biopsy. A small tissue sample from the surface of the eye may be removed for laboratory examination to help diagnose a condition that is unclear. For this procedure, the eye is numbed with anesthetic eye drops. The required tissue is collected, an antibiotic ointment is placed in the eye to prevent infection, and a patch may be placed over the eye for 12 to 24 hours.
- Blood draw for tests to study the cause of the patient's eye disease.
- Other diagnostic tests as needed.
- DNA testing to look for a genetic pattern associated with the patient's eye disease.
Patients who are found eligible for an NEI study will be offered participation in that study. Patients who are not eligible for current studies will be advised about treatment options.
Detailed description
This is a screening protocol that will allow the NEI clinicians to examine patients with ocular diseases in order to identify those who may be eligible to participate in other NEI studies on anterior segment disease.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8981714Holland EJ. Epithelial transplantation for the management of severe ocular surface disease. Trans Am Ophthalmol Soc. 1996;94:677-743.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00088348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.