Recruiting

Scleral Lens

Sponsor:

Oregon Health and Science University

Code:

NCT04570020

Conditions

Keratoconus

Irregular; Contour of Cornea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04570020

Start date

Sep 23, 2020

Status verified date

Sep, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

258 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Apical Clearance [ Time Frame: 5 years ]
  • Limbal Clearance [ Time Frame: 5 years ]
  • Conjunctival Compression [ Time Frame: 5 years ]
  • Lens Edge Lift [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

Locations

Oregon Health & Science University, Casey Eye Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denzil Romfh, OD

503-494-4351romfhd@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-09-09.