NCT04570020 Scleral Lens Fitting Using Wide-Field OCT
| NCT ID | NCT04570020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Keratoconus |
| Study Type | OBSERVATIONAL |
| Enrollment | 258 participants |
| Start Date | 2020-09-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 258 participants in total. It began in 2020-09-23 with a primary completion date of 2027-12.
⚠ 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
The purpose of this study is to see if OCT technology can optimize scleral contact lens fittings. Subjects with keratoconus, post-penetrating keratoplasty (PK), post-LASIK ectasia, post-radial keratotomy (RK), or a variety of anterior surface disorders requiring scleral lens fittings will be considered for enrollment. For each study eye, a clinically-selected scleral lens fit will be compared against an OCT-selected lens fit. The quality of each lens fit will be determined by flourescein exam at the slit lamp. Apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be assessed. A lens that satisfies all four criteria will be considered satisfactory.
Eligibility Criteria
Inclusion Criteria: * Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders Exclusion Criteria: * Inability to maintain stable fixation for OCT imaging * Inability to commit to required visits to complete the study * Eyes with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcome
Contact & Investigator
David Huang, MD, PhD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT04570020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT04570020 currently recruiting?
Yes, NCT04570020 is actively recruiting participants. Contact the research team at martinhu@ohsu.edu for enrollment information.
Where is the NCT04570020 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT04570020 clinical trial?
NCT04570020 is sponsored by Oregon Health and Science University. The principal investigator is David Huang, MD, PhD at Oregon Health and Science University. The trial plans to enroll 258 participants.