CataractNCT00005911
Magnetic Resonance Imaging to Study the Normal Eye
An observational study of Cataract and Lens Disease, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
This study will assess the value of improved magnetic resonance imaging (MRI) techniques to study the lens of the human eye. Knowledge of how cataracts develop and progress has been hampered by the lack of human tissue available for study; MRI may provide an effective means for learning more about this eye disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Aug 2002
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Must be between 18 and 70 years of age of either sex.
Must not have uveitis, glaucoma, or be at risk for an adverse reaction to dilation or have a history of allergic reaction to one of lthe dilating agents to be used.
Must not have any metallic prosthesis, cardiac pacemakers, neural pacemakers, surgical clips in the brain or on blood vessels, surgically implanted metal plates, screws or pins, cochlear implants or metal objects in the body especially in the eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Official title: Refinement of the Magnetic Resonance Imaging Technique for the Study of the Normal Eye, Particularly the Lens and Cataract
This study will assess the value of improved magnetic resonance imaging (MRI) techniques to study the lens of the human eye. Knowledge of how cataracts develop and progress has been hampered by the lack of human tissue available for study; MRI may provide an effective means for learning more about this eye disease.
Normal volunteers between 18 and 70 years of age may be eligible for this study. Participants will undergo a medical history and complete eye examination, including vision assessment, eye pressure measurement, lens and retina examinations, and photography of the eye.
MRI scans will be scheduled for a second visit. For this procedure, the volunteer's pupils are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a magnetic field. A device similar to a welder's helmet is placed on the head. Attached to the device are an imaging probe and a small blinking light. The probe receives radio signals from the eye that a computer converts into images. During imaging, the participant gazes at the blinking light; this helps keep the eyes from blinking and wandering. Scan times vary from 2 to 10 minutes; the total time for the study is less than an hour.
Read the detailed description
Studies of human diabetic cataract and age related cataract formation have been hampered by unavailability of human tissues especially in the early stages of the disease. Eye bank tissues are first used for cornea transplants so that by the time they become available for basic research studies, the lens is no longer suitable for biochemical nor histological studies. Cataracts usually only become available after extraction which is at the end stage of their development. However, appropriate surgical lens specimens are no longer available because cataracts are generally extracted by the destructive phakoemulsification technique. Therefore, noninvasive techniques are required in order to study the lens in vivo.
- Conditions
- Cataract, Lens Disease
- Keywords
- Magnetic Resonance Imaging, Human Eye, Lens, Normal Volunteers, Cataract, Human Lens, Healthy Volunteer
- Medical subject headings
- Cataract, Lens Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2000 (estimated)
- Study startJun 2000
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005911
- Sponsor's protocol ID
- 000151
- Other IDs
- 00-EI-0151
- Status last verified
- Aug 2002
- First submitted
- 13 Jun 2000
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kinoshita JH, Kador P, Catiles M. Aldose reductase in diabetic cataracts. JAMA. 1981 Jul 17;246(3):257-61. No abstract available.
PubMed 6787220Reddy VN, Schwass D, Chakrapani B, Lim CP. Biochemical changes associated with the development and reversal of galactose cataracts. Exp Eye Res. 1976 Nov;23(5):483-93. doi: 10.1016/0014-4835(76)90157-3. No abstract available.
PubMed 1001376Datiles M, Fukui H, Kuwabara T, Kinoshita JH. Galactose cataract prevention with sorbinil, an aldose reductase inhibitor: a light microscopic study. Invest Ophthalmol Vis Sci. 1982 Feb;22(2):174-9.
PubMed 6799419
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
- Refinement of the Magnetic Resonance Imaging Technique for the Study of the Normal Eye, Particularly the Lens and Cataract
- ClinicalTrials.gov ID
- NCT00005911
- Acronym / sponsor ID
- 000151
- Conditions
- Cataract, Lens Disease
- Keywords
- Magnetic Resonance Imaging, Human Eye, Lens, Normal Volunteers, Cataract, Human Lens, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Jun 2000
- Study completion
- Aug 2002
- First posted
- 14 Jun 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 will assess the value of improved magnetic resonance imaging (MRI) techniques to study the lens of the human eye. Knowledge of how cataracts develop and progress has been hampered by the lack of human tissue available for study; MRI may provide an effective means for learning more about this eye disease.
Normal volunteers between 18 and 70 years of age may be eligible for this study. Participants will undergo a medical history and complete eye examination, including vision assessment, eye pressure measurement, lens and retina examinations, and photography of the eye.
MRI scans will be scheduled for a second visit. For this procedure, the volunteer's pupils are dilated and he or she then lies on a stretcher that is moved into a cylinder containing a magnetic field. A device similar to a welder's helmet is placed on the head. Attached to the device are an imaging probe and a small blinking light. The probe receives radio signals from the eye that a computer converts into images. During imaging, the participant gazes at the blinking light; this helps keep the eyes from blinking and wandering. Scan times vary from 2 to 10 minutes; the total time for the study is less than an hour.
Detailed description
Studies of human diabetic cataract and age related cataract formation have been hampered by unavailability of human tissues especially in the early stages of the disease. Eye bank tissues are first used for cornea transplants so that by the time they become available for basic research studies, the lens is no longer suitable for biochemical nor histological studies. Cataracts usually only become available after extraction which is at the end stage of their development. However, appropriate surgical lens specimens are no longer available because cataracts are generally extracted by the destructive phakoemulsification technique. Therefore, noninvasive techniques are required in order to study the lens in vivo.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- 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 4 Mar 2008.
- Background: PubMed 6787220Kinoshita JH, Kador P, Catiles M. Aldose reductase in diabetic cataracts. JAMA. 1981 Jul 17;246(3):257-61. No abstract available.
- Background: PubMed 1001376Reddy VN, Schwass D, Chakrapani B, Lim CP. Biochemical changes associated with the development and reversal of galactose cataracts. Exp Eye Res. 1976 Nov;23(5):483-93. doi: 10.1016/0014-4835(76)90157-3. No abstract available.
- Background: PubMed 6799419Datiles M, Fukui H, Kuwabara T, Kinoshita JH. Galactose cataract prevention with sorbinil, an aldose reductase inhibitor: a light microscopic study. Invest Ophthalmol Vis Sci. 1982 Feb;22(2):174-9.
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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 Cataract and Lens Disease, 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?
On the ClinicalTrials.gov record for NCT00005911, which also lists 3 linked publications.
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; AzTrials last refreshed its copy on 2 Nov 2026.