| NCT ID | NCT03504800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Keratoconus |
| Study Type | OBSERVATIONAL |
| Enrollment | 445 participants |
| Start Date | 2018-05-01 |
| Primary Completion | 2030-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 445 participants in total. It began in 2018-05-01 with a primary completion date of 2030-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions. The primary goal will be achieved by using optical coherence tomography (OCT) to: 1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities. 2. Develop OCT metrics for more sensitive detection of keratoconus progression. 3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.
Eligibility Criteria
Inclusion Criteria: GROUP A: * Keratoconus: 1. CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye 2. Topography characteristic of keratoconus or pellucid marginal degeneration * Contact lens-related corneal warpage: 1. Contact lens use; and 2. Topography irregularities * Dry eye: 1. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and 2. Topography irregularities 3. Presence of punctate epithelial erosion on exam with surface staining 4. Aqueous deficiency or evaporative dry eye * Epithelial basement membrane dystrophy (EBMD): 1. Negative corneal fluorescein staining; and 2. Corneal opacities; and 3. Topography irregularities * Stromal addition or subtraction: 1. Scars; or 2. Salzmann's degeneration; or 3. Stromal dystrophies; or 4. Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK) * Stromal distortion: 1. Radial keratectomy (RK); or 2. Corneal transplants. * Normal controls: 1. Healthy eyes with no previous eye procedures/surgeries. GROUP B: Participants will be selected from the keratoconus population in Group A based on topography findings. GROUP C: Participants will be selected from the stromal addition/subtraction and stromal distortion populations of Group A if they have vision primarily limited by scars, dystrophy, or high astigmatism that could benefit from PTK. Exclusion Criteria (all groups): * Inability to give informed consent. * Inability to maintain fixation for OCT imaging. * Inability to commit to required study visits. * Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery. * Previous corneal surgeries if considered as a keratoconus participant. * Pregnancy or breastfeeding.
Contact & Investigator
Yan Li, PhD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT03504800 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 85 Years, studying Keratoconus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03504800 currently recruiting?
Yes, NCT03504800 is actively recruiting participants. Contact the research team at martinhu@ohsu.edu for enrollment information.
Where is the NCT03504800 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT03504800 clinical trial?
NCT03504800 is sponsored by Oregon Health and Science University. The principal investigator is Yan Li, PhD at Oregon Health and Science University. The trial plans to enroll 445 participants.