Scleral Lens Fitting Using Wide-Field OCT

NCT ID: NCT04570020

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-23

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Keratoconus Irregular; Contour of Cornea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinically-Selected Scleral Lens

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

No interventions assigned to this group

OCT-Selected Scleral Lens

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

Peterson Professor of Ophthalmology & Professor of Biomedical Engineering

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University, Casey Eye Institute

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Humberto Martinez, COT

Role: CONTACT

503-494-7712

Denzil Romfh, OD

Role: CONTACT

503-494-4351

Facility Contacts

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Humberto Martinez, COT

Role: primary

503-494-7712

Denzil Romfh, OD

Role: backup

503-494-4351

Other Identifiers

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R01EY028755

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6612-SCLERAL LENS

Identifier Type: -

Identifier Source: org_study_id

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