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 |
Trial Parameters
Eligibility Fast-Check
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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