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Scleral Lens Fitting Using Wide-Field OCT

Sponsor
Oregon Health and Science University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04570020
Collaborator
National Eye Institute (NEI) (NIH)
258
Enrollment
1
Location
50.3
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    258 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Trial of OCT-based Scleral Lens Fitting With Wide-Field OCT
    Actual Study Start Date :
    Sep 23, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Apical Clearance [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 [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 [5 years]

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

    4. Lens Edge Lift [5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University, Casey Eye Institute Portland Oregon United States 97239

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: David Huang, MD, PhD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Huang, Peterson Professor of Ophthalmology & Professor of Biomedical Engineering, Oregon Health and Science University
    ClinicalTrials.gov Identifier:
    NCT04570020
    Other Study ID Numbers:
    • 6612-SCLERAL LENS
    • R01EY028755
    First Posted:
    Sep 30, 2020
    Last Update Posted:
    Sep 30, 2020
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by David Huang, Peterson Professor of Ophthalmology & Professor of Biomedical Engineering, Oregon Health and Science University
    Keratoconus (KCN)
    Irregular Cornea
    Optical Coherence Tomography (OCT)
    Additional relevant MeSH terms:
    Keratoconus

    Study Results

    No Results Posted as of Sep 30, 2020