Scleral Lens Fitting Using Wide-Field OCT

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Keratoconus; Irregular; Contour of Cornea

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04570020

6612-SCLERAL LENS

R01EY028755 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 258 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

258 participants in 2 patient groups

Clinically-Selected Scleral Lens

Description:

The clinically-selected lens is based on slit lamp assessment. This lens will be compared against an OCT-selected lens.

OCT-Selected Scleral Lens

Description:

The OCT-selected lens is based on OCT measurements. This lens will be compared against a clinically-selected lens.