Optimizing scleral lens fittings using advanced imaging technology
Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
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 |
|---|---|
| Enrollment | 258 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT04570020 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with keratoconus, post-penetrating keratoplasty, post-LASIK ectasia, or other anterior surface disorders needing scleral lens fittings.
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.
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 performed: While the use of OCT in lens fitting is a relatively novel approach, similar studies have shown promising results in optimizing contact lens fittings.
Eligibility criteria
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 this trial is running
Portland, Oregon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.