Optimizing scleral lens fittings using advanced imaging technology
Official title: Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
Run by Oregon Health and Science University · NCT04570020 · Data updated 2026-11-12
This study is testing if using advanced imaging technology can help fit scleral contact lenses better for people with keratoconus and other corneal issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 258 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Status | Recruiting |
| Started | September 23, 2020 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | September 9, 2025 |
| Trial ID | NCT04570020 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with keratoconus, post-penetrating keratoplasty, post-LASIK ectasia, or other anterior surface disorders needing scleral lens fittings.
✕Probably not a fit
Patients with concurrent retinal diseases, glaucoma, or other eye conditions that may limit visual outcomes are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of Optical Coherence Tomography (OCT) in enhancing the fitting process for scleral contact lenses in patients with keratoconus and other corneal irregularities. Participants will undergo fittings using both clinically-selected and OCT-selected lenses, with the quality of each fit assessed through a fluorescein examination at the slit lamp. Key parameters such as apical clearance, limbal clearance, conjunctival compression, and lens edge lift will be measured to determine the optimal lens fit. The goal is to identify which fitting method provides better outcomes for patients requiring scleral lenses.
Why it matters
Potential benefit: If successful, this study could lead to improved comfort and visual outcomes for patients requiring scleral lenses.
How similar studies have gone: While the use of OCT in lens fitting is a relatively novel approach, similar studies have shown promising results in optimizing contact lens fittings.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Oregon Health & Science University, Casey Eye Institute
Portland, Oregon, United States Recruiting
Study contacts
- Principal investigator: David Huang, MD, PhD — Oregon Health and Science University
- Study coordinator: Humberto Martinez, COT
- Email: martinhu@ohsu.edu
- Phone: 503-494-7712
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Corneal Crosslinking to Treat Progressive Keratoconus or Corneal Ectasia
This study tests two different light durations used in corneal crosslinking to see which better helps people with keratoconus or corneal ectasia.
-
Brillouin hydration mapping to study cornea health
Researchers test a Brillouin microscope to see if it can measure corneal water content in healthy people and those with eye conditions.
-
Same-day bilateral corneal cross-linking for keratoconus
This trial tests whether performing corneal cross-linking in both eyes on the same day is safe and feasible for people with keratoconus.
-
A Smart Aperture Lens to Help Keratoconus and Presbyopia
This study tests the NOA lens, a custom scleral contact lens with a central aperture, to see if it improves vision for people with keratoconus and presbyopia.
-
GLK-221 eye drops for keratoconus
This trial will test whether twice-daily GLK-221 eye drops are safe and help adults aged 18–55 with keratoconus compared with a placebo.
-
Corneal wavefront-guided PRK plus epi-off CXL versus PTK plus epi-off CXL for keratoconus
This trial tests whether adding corneal wavefront-guided PRK to epi-off corneal cross-linking gives better vision than PTK plus epi-off CXL in adults with keratoconus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.