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NCT Number: NCT04570020

Scleral Lens Fitting Using 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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases Irregular; Contour of Cornea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health & Science University, Casey Eye Institute

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Afshan Nanji, MD

SUB_INVESTIGATOR

Denzil Romfh, OD

CONTACT

[email protected]

503-494-4351

Derek Louie, OD

SUB_INVESTIGATOR

Humberto Martinez, COT

CONTACT

[email protected]

503-494-7712

Richard Stutzman, MD

SUB_INVESTIGATOR

Winston Chamberlain, MD, PhD

SUB_INVESTIGATOR

Yan Li, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Apical Clearance

    Time frame: 5 years

    Apical clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too high," or "too low."

  2. Limbal Clearance

    Time frame: 5 years

    Limbal clearance of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable," "too much," or "too little."

  3. Conjunctival Compression

    Time frame: 5 years

    Conjunctival compression of each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."

  4. Lens Edge Lift

    Time frame: 5 years

    Lens edge lift for each lens (whether clinically-selected or OCT-selected) will be graded as "acceptable" or "excessive."

Study contacts

Contact information is provided by the study sponsor or research team.

Denzil Romfh, OD

CONTACT

[email protected]

503-494-4351

Humberto Martinez, COT

CONTACT

[email protected]

503-494-7712

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Sep 30, 2020
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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