Scleral Lens Fitting Using Wide-Field OCT

NCT04570020 | Recruiting

• 2 other identifiers: 6612-SCLERAL LENSR01EY028755
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus; Irregular; Contour of Cornea

Keywords

Keratoconus (KCN); Irregular Cornea; Optical Coherence Tomography (OCT)

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female subjects meeting the eye criteria listed above.

You may qualify if:

• Eyes requiring fit for scleral lenses for KCN, post-PK, post-RK, post-LASIK ectasia, or various anterior surface disorders

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Oregon Health & Science University, Casey Eye Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• David Huang, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Humberto Martinez, COT

CONTACT

503-494-7712; martinhu@ohsu.edu

Denzil Romfh, OD

CONTACT

503-494-4351; romfhd@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peterson Professor of Ophthalmology & Professor of Biomedical Engineering

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: September 23, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)