Scleral Lens Fitting Using Wide-Field OCT

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT04570020
Status
Recruiting
Apply to this trial

Conditions

  • Irregular; Contour of Cornea
  • Keratoconus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Sep 23, 2020
Status verified
Sep 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
258 participants (estimated)

Arms

  • Arm: Clinically-Selected Scleral Lens
    The clinically-selected lens is based on slit lamp assessment. This lens will be compared against an OCT-selected lens.
  • Arm: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oregon Health & Science University, Casey Eye InstitutePortlandOregon97239
Humberto Martinez, COT
[email protected]
503-494-7712
Denzil Romfh, OD
[email protected]
503-494-4351
Winston Chamberlain, MD, PhD (SUB_INVESTIGATOR)
Afshan Nanji, MD (SUB_INVESTIGATOR)
Derek Louie, OD (SUB_INVESTIGATOR)
Yan Li, PhD (SUB_INVESTIGATOR)
Richard Stutzman, MD (SUB_INVESTIGATOR)

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By research site
Oregon Health & Science University, Casey Eye Institute· Portland, OR

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