An observational study in Fuch's Dystrophy, Corneal Disorders and Prior Surgery, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by NYU Langone Health · Observational
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Among 76 studies in Corneal Diseases with a site in United States — 12 open to participants now, 13 under way, 3 of them phase 3. Corneal Diseases · United States.
Among the 76 studies in Corneal Diseases with a site in United States, this one is the 21st largest by enrollment of the 22 observational ones that give a count, is one of 2 that started in 2005, is one of 22 observational ones, and was the 9th registered.
219 studies on the registry are indexed under Corneal Diseases; 43 are open to participants now.
Browse Corneal Diseases studies →12 of the 76 studies in Corneal Diseases with a site in United States are open now. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 20–79 · Healthy volunteers
University of Maryland, Baltimore · Sites in United States
Ages 18+ · Healthy volunteers
Woolfson Eye Institute · Sites in United States
Ages 8+
Duke University · Sites in United States
Ages 18+
Optos, PLC · Sites in United States
Ages 22+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Corneal Diseases studies recruiting now, 21 (64%) set no upper age limit and 5 (15%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
76 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 9 · Phase 3 14 · Phase 4 5
First in 1992; this study’s year is marked. 2 started in 2005.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 100 across 73 observational studies indexed under Corneal Diseases.
Median enrollment 79 across the 54 interventional studies, 90 across the 22 observational. Of the 54 that completed or were terminated, 15 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 76 have an industry lead sponsor. The 10 most frequent:
NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
NYU Langone Health has 1 study filed under Corneal Diseases — fewer than ten, so there is no comparison to draw.
6 of the studies in Corneal Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06993597University of Maryland, BaltimoreStudy of Corneal Biomechanics in Glaucoma Patients Using Brillouin Microscopy | 2027-03 |
| NCT03030755The Cleveland ClinicCorneal Elastography and Patient Specific Modeling | 2027-05 |
| NCT06854393Henry M. Jackson Foundation for the Advancement of Military MedicineLacripep for Corneal Wound Healing Study | 2027-06 |
| NCT04439552Boston Children's HospitalfMRI and IVCM Cornea Microscopy of CXL in Keratoconus | 2027-08 |
| NCT07780890Massachusetts General HospitalA Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases | 2027-09-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 76 studies in Corneal Diseases with a site in United States, from their registry updates:
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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.
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
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 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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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: 2 years
Plan to share: Undecided
Ran from Oct 2005 to primary completion in Sep 2019, 167 months.
Of 25 observational studies under Corneal Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 76. This study's 167 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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