Exfoliation SyndromeNCT02042703
Imaging Lens Deposits in Exfoliation Syndrome
An observational study of Exfoliation Syndrome and Primary Open Angle Glaucoma, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Exfoliation Syndrome, Primary Open Angle Glaucoma, Cataracts
- What is being tested?
- anterior segment OCT
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 2015
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from Glaucoma and Comparehensive clinics at the duke Eye Center.
Who may be able to join
- Diagnosis of exfoliation syndrome, primary open angle glaucoma (POAG), or cataracts
Who cannot join
- Unable to provide or sign consent
- Pseudophakia
- Other prior intraocular surgery
- Other eye diseases other than refractive error
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Imaging Lens Changes in Exfoliation Syndrome Using Anterior Segment OCT
The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the eye without requiring contact with the eye. We will compare lens images of subjects with exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis of exfoliation syndrome to track disease progression and see how they respond to possible treatments. We also hope that with this imaging technology we can detect early changes in currently unaffected eyes, which could be useful for predicting which patients may develop the disease.
- Conditions
- Exfoliation Syndrome, Primary Open Angle Glaucoma, Cataracts
- Being tested
- anterior segment OCT
- Medical subject headings
- Exfoliation Syndrome, Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior segment OCTDevice
| Study group | Role | What they receive |
|---|---|---|
| exfoliation syndrome | patients with exfoliation syndrome Receives: Device: anterior segment OCT | |
| POAG | patients with primary open angle glaucoma (POAG) Receives: Device: anterior segment OCT | |
| cataracts | patients with cataracts Receives: Device: anterior segment OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of exfoliation deposits on the lens as measured by AS-OCT
Measured: 20 min (length of imaging)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Unanticipated slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exfoliation SyndromeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042703
- Sponsor's protocol ID
- Pro00050919
- Status last verified
- Oct 2015
- First submitted
- 21 Jan 2014
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Lens Changes in Exfoliation Syndrome Using Anterior Segment OCT
- ClinicalTrials.gov ID
- NCT02042703
- Acronym / sponsor ID
- Pro00050919
- Conditions
- Exfoliation Syndrome, Primary Open Angle Glaucoma, Cataracts
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unanticipated slow enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Jan 2014 (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.
The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the eye without requiring contact with the eye. We will compare lens images of subjects with exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis of exfoliation syndrome to track disease progression and see how they respond to possible treatments. We also hope that with this imaging technology we can detect early changes in currently unaffected eyes, which could be useful for predicting which patients may develop the disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exfoliation syndrome | – | Device: anterior segment OCTpatients with exfoliation syndrome |
| POAG | – | Device: anterior segment OCTpatients with primary open angle glaucoma (POAG) |
| cataracts | – | Device: anterior segment OCTpatients with cataracts |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from Glaucoma and Comparehensive clinics at the duke Eye Center.
Key inclusion criteria (1 listed)
- Diagnosis of exfoliation syndrome, primary open angle glaucoma (POAG), or cataracts
Key exclusion criteria (4 listed)
- Unable to provide or sign consent
- Pseudophakia
- Other prior intraocular surgery
- Other eye diseases other than refractive error
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 |
|---|---|---|
| anterior segment OCT | Device | POAG, cataracts, exfoliation syndrome |
Primary outcome
Amount of exfoliation deposits on the lens as measured by AS-OCT
Time frame: 20 min (length of imaging)
Results and safety
The study was stopped early (reason given: Unanticipated slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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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 Exfoliation Syndrome and Primary Open Angle Glaucoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2015. 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 was stopped early (reason given: Unanticipated slow enrollment). Results are not available in the source record.
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.
What does the primary outcome measure?
Amount of exfoliation deposits on the lens as measured by AS-OCT (time frame: 20 min (length of imaging)). It is what the study was designed to measure, not a finding.
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 21 Oct 2015.