WFG Sclerals: Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism

Sponsor
Cornea and Laser Eye Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04698590
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
23.5
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aberrations are the spreading of light from a point focus. Aberrations of the eyes can be objectively evaluated with a wavefront aberrometer. Lower order aberrations such as defocus and astigmatism can be corrected with glasses and traditional/disposable soft contact lenses. Patients with ectatic corneal disease, such as keratoconus, or irregular astigmatism cause by surgery, trauma or disease, experience vision that is unlikely to be adequately corrected with glasses or disposable soft contact lenses due to higher order aberrations (HOA). HOA's cause halos, flare, glare, starbursts, doubling, smearing or ghosting of vision. Specialty contact lenses, such as scleral lenses, can be used to mask the irregularity of the cornea, reducing HOA's and improving vision. In many patients the resultant vision, though improved, still has some level of residual HOA's affecting the quality of vision. Custom scleral lenses with customized wavefront guided optics can be used to reduce residual HOA's and improve vision further. These lenses have been referred to as higher order aberration correcting scleral lenses or HOA correcting sclerals and wavefront guided scleral lenses or WFG sclerals.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Wavefront Guided Scleral Lenses
  • Device: Traditional Scleral Lenses
N/A

Detailed Description

The purpose of this study is to investigate the effect of an advanced technique for designing custom scleral contact lenses to further improve vision in keratoconus or irregular astigmatism by reducing residual aberrations. The derived custom scleral lenses will include customized aberration correcting optics, guided by a wavefront aberrometer measurements. These lenses are custom made based on the individual measurements from an eye.The primary objective of this study is to evaluate the vision differences between traditional scleral lens optics and customized scleral lens optics. In particular, the investigators will compare efficacy in reducing aberrations and improvement in vision.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus or Irregular Astigmatism
Actual Study Start Date :
Jan 15, 2021
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: WFG Scleral Lenses

Scleral lenses with customized wavefront guided optics

Device: Wavefront Guided Scleral Lenses
Custom wavefront guided, higher order aberration correcting scleral lenses
Other Names:
  • ARES Scleral Lenses
  • Placebo Comparator: Traditional Scleral Lenses

    Scleral lenses with traditional optics

    Device: Traditional Scleral Lenses
    Traditional scleral lenses
    Other Names:
  • CS Scleral Lenses
  • Outcome Measures

    Primary Outcome Measures

    1. Higher order aberration [4 weeks]

      Total higher order aberrations with traditional scleral lenses will be compared with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in total higher order aberrations with wavefront guided scleral lenses from dispense to 4 week follow up, will be evaluated.

    Secondary Outcome Measures

    1. Visual Acuity [4 weeks]

      Visual acuity with traditional scleral lenses will be compared to visual acuity with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in visual acuity from dispense to 4 week follow up, will be evaluated for signs of neural adaptation.

    2. Contrast Sensitivity [4 weeks]

      Contrast sensitivity with traditional scleral lenses will be compared to contrast sensitivity with wavefront guided scleral lenses for all eyes. A secondary analysis of this endpoint, the change in contrast sensitivity with wavefront guided scleral lenses from dispense to 4 week follow up, will be evaluated for signs of neural adaptation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    -A diagnosis of keratoconus or irregular astigmatism

    Exclusion Criteria:
    • Patients with other visually significant ocular pathology.

    • Inability to apply or remove a scleral lens.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Cornea and Laser Eye Institue - Hersh Vision GroupTeaneckNew JerseyUnited States07666

    Sponsors and Collaborators

    • Cornea and Laser Eye Institute

    Investigators

    • Principal Investigator: John D Gelles, OD, The Cornea and Laser Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cornea and Laser Eye Institute
    ClinicalTrials.gov Identifier:
    NCT04698590
    Other Study ID Numbers:
    • CLEI WFG Scleral Lens
    First Posted:
    Jan 7, 2021
    Last Update Posted:
    Apr 19, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Cornea and Laser Eye Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2021