Fuch's DystrophyNCT00343473
Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye
An observational study of Fuch's Dystrophy and Corneal Disorders, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye)… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fuch's Dystrophy, Corneal Disorders, Prior Surgery
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2005to 14 Feb 2024
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will range form 18 years to 90 years. Gender can be male or female. Will include 100 normals and 100 diseased patients that include diabetic retinopathy, macular degeneration, and glaucoma.
Inclusion Criteria: Female Subjects who are pregnant or breastfeeding will be included (no risks to fetus).
Normals: Normal appearing cornea, no history of corneal trauma, surgery or disease, no historical or current contact lens wear. Thirty subjects from 6 different age groups (> 18 yrs; 20-30 yrs; 30-40 yrs; 40-50 yrs; 50-60 yrs; > 60 yrs) will be recruited to determine the normal variations in anterior eye structure.
LASIK patients: to participate as a LASIK patient, the subject is previously normal but may have worn contact lenses, and is scheduled to undergo LASIK.
Contact lens wearers: to participate as a contact lens wearer the patient otherwise fulfills all criteria specified for normalcy, with the exception of contact lens wear.
Fuchs' dystrophy patients: Fuchs' Dystrophy is characterized by guttata and clinically significant corneal edema, with a corneal thickness of >700 microns, and/or reduced visual acuity in the morning which improves over the course of the day.
Diabetic patients: for diabetic patients are specified in the posterior segment imaging section.
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Exclusion Criteria:Subjects will be excluded from the study if their media are opaque, or if they are unwilling or unable to participate in the study.
If participants choose they may also participate in other imaging research protocols. No risk is associated if entering multiple imaging protocols, while being a participant in this research study.
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Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York University School of Medicine
New York, New York, 10016
University of Pittsburgh UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes.
Read the detailed description
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes. OCT may also be useful for assessing contact lens and surgical procedures, such as LASIK (type of ophthalmic surgical procedure). The OCT is Food and Drug Administration (FDA) approved. The ultra high OCT is a non-significant risk device (it does not present a possible serious risk to your health, your safety, or your welfare) that has not been approved by the FDA. This study will also be conducted at the Massachusetts Institute of Technology and Tufts-New England Medical Center New England Eye Center in Massachusetts
- Conditions
- Fuch's Dystrophy, Corneal Disorders, Prior Surgery
- Keywords
- Fuch's dystrophy, corneal disorders, cornea, lasik, refractive surgery
- Medical subject headings
- Corneal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startOct 2005
- Primary completion12 Sep 2019
- Study completion14 Feb 2024
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 Fuch's DystrophyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Other
- Time perspective
- Other
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Chaim Wollstein, MD, Principal investigator, NYU Langone HealthIan Conner, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343473
- Sponsor's protocol ID
- s17-00039
- Other IDs
- R01EY011289-15
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2006
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christopoulos V, Kagemann L, Wollstein G, Ishikawa H, Gabriele ML, Wojtkowski M, Srinivasan V, Fujimoto JG, Duker JS, Dhaliwal DK, Schuman JS. In vivo corneal high-speed, ultra high-resolution optical coherence tomography. Arch Ophthalmol. 2007 Aug;125(8):1027-35. doi: 10.1001/archopht.125.8.1027.
PubMed 17698748
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Diagnostics With Optical Coherence Tomography: Imaging of the Anterior Eye
- ClinicalTrials.gov ID
- NCT00343473
- Acronym / sponsor ID
- s17-00039
- Conditions
- Fuch's Dystrophy, Corneal Disorders, Prior Surgery
- Keywords
- Fuch's dystrophy, corneal disorders, cornea, lasik, refractive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Oct 2005 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 23 Jun 2006 (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 research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes.
Detailed description
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes. OCT may also be useful for assessing contact lens and surgical procedures, such as LASIK (type of ophthalmic surgical procedure). The OCT is Food and Drug Administration (FDA) approved. The ultra high OCT is a non-significant risk device (it does not present a possible serious risk to your health, your safety, or your welfare) that has not been approved by the FDA. This study will also be conducted at the Massachusetts Institute of Technology and Tufts-New England Medical Center New England Eye Center in Massachusetts
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will range form 18 years to 90 years. Gender can be male or female. Will include 100 normals and 100 diseased patients that include diabetic retinopathy, macular degeneration, and glaucoma.
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
Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye
Time frame: 2 years
The purpose of this research is to evaluate the optical coherence tomography (OCT), to image diseases of the eye. OCT may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as Fuch's Dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes
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 1 Jul 2024.
- Derived from this study: PubMed 17698748Christopoulos V, Kagemann L, Wollstein G, Ishikawa H, Gabriele ML, Wojtkowski M, Srinivasan V, Fujimoto JG, Duker JS, Dhaliwal DK, Schuman JS. In vivo corneal high-speed, ultra high-resolution optical coherence tomography. Arch Ophthalmol. 2007 Aug;125(8):1027-35. doi: 10.1001/archopht.125.8.1027.
- Individual participant dataSharing planned: Undecided
Related trials for Fuch's Dystrophy
RecruitingPhase 2
Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy
RecruitingPhase 4
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
Fuchs' Endothelial Dystrophy
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.
Chaim Wollstein, MD principal investigator
NYU Langone Health
Ian Conner, MD, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fuch's Dystrophy and Corneal Disorders, run by NYU Langone Health at 2 sites 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?
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: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Novel Diagnostics With Optical Coherence Tomography: Imaging the Anterior Eye (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00343473, 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 1 Jul 2024.