Scleral Lens Fitting Using Wide-Field OCT

Recruiting

• Conditions: Keratoconus; Irregular; Contour of Cornea

• Registration Number: NCT04570020
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-23
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-09-24
• Study First Posted: 2020-09-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Conjunctival Compression	5 years	Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."
Lens Edge Lift	5 years	Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."
Apical Clearance	5 years	Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low."
Limbal Clearance	5 years	Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too much," or "too little."

Trial Locations

Locations (1)

Oregon Health & Science University, Casey Eye Institute; 🇺🇸 Portland, Oregon, United States