Ocular Motility DisorderNCT00006422
Evaluation and Treatment of Pediatric Eye Diseases
A study of Ocular Motility Disorder, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Motility Disorder
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Oct 2002
- Phase
- Interventional
- 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
Must have a disorder of ocular motility or a pediatric specific eye disease.
Must have the ability to understand and sign an informed consent form or have a legal guardian/parent with the ability to do the same.
Patients must have the ability to be followed at the NEI clinical center for at least the next 3 years.
Presence of severe systemic diseases such as developmental delay, cancer and others that may compromise the evaluation of the eye disease may exclude patient from this protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation and Treatment Protocol for Patients With Pediatric Eye Diseases and Strabismus
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 patient's 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 patient's 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.
Read the 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 patient's 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.
- Conditions
- Ocular Motility Disorder
- Being tested
- current standard of care treatments
- Keywords
- Lazy Eye, Amblyopia, Nystagmus, Eye Movements, Child Vision
- Medical subject headings
- Ocular Motility Disorders, Amblyopia, Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
current standard of care treatmentsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2000 (estimated)
- Study startOct 2000
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Motility DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006422
- Sponsor's protocol ID
- 010023
- Other IDs
- 01-EI-0023
- Status last verified
- Oct 2002
- First submitted
- 27 Oct 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment Protocol for Patients With Pediatric Eye Diseases and Strabismus
- ClinicalTrials.gov ID
- NCT00006422
- Acronym / sponsor ID
- 010023
- Conditions
- Ocular Motility Disorder
- Keywords
- Lazy Eye, Amblyopia, Nystagmus, Eye Movements, Child Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Oct 2000
- Study completion
- Oct 2002
- First posted
- 30 Oct 2000 (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 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 patient's 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 patient's 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 patient's 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 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| current standard of care treatments | Procedure or surgery | – |
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 4 Mar 2008.
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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?
A study of Ocular Motility Disorder, 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 4 Mar 2008. 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?
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 4 Mar 2008.