Scleral Lens Fitting Using Wide-Field OCT

Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT

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.

Study Overview

• Status: Recruiting
• Conditions: Keratoconus; Irregular; Contour of Cornea

• Study Type: Observational
• Enrollment (Estimated): 258

Contacts and Locations

• Study Contact: Name: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu
• Study Contact Backup: Name: Denzil Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University, Casey Eye Institute
      • Sub-Investigator: Derek Louie, OD
      • Contact: Humberto Martinez, COT; Phone Number: 503-494-7712; Email: martinhu@ohsu.edu
      • Contact: Denzil Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu
      • Sub-Investigator: Winston Chamberlain, MD, PhD
      • Sub-Investigator: Afshan Nanji, MD
      • Sub-Investigator: Richard Stutzman, MD
      • Sub-Investigator: Yan Li, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects meeting the eye criteria listed above.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Clinically-Selected Scleral Lens; The clinically-selected lens is based on slit lamp assessment. This lens will be compared against an OCT-selected lens.
OCT-Selected Scleral Lens; The OCT-selected lens is based on OCT measurements. This lens will be compared against a clinically-selected lens.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 24, 2020
• First Posted (Actual): September 30, 2020

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography (OCT); Keratoconus (KCN); Irregular Cornea
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: 6612-SCLERAL LENS; R01EY028755 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No