Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism (WFG Sclerals)

Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus or Irregular Astigmatism

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Keratoconus; Corneal Ectasia; Irregular Astigmatism; Aberration, Corneal Wavefront; Wavefront Aberration, Corneal; Pellucid Marginal Corneal Degeneration; Keratoglobus
• Intervention / Treatment: Device: Wavefront Guided Scleral Lenses; Device: Traditional Scleral Lenses

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Cornea and Laser Eye Institue - Hersh Vision Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Higher order aberration	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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	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.	4 weeks
Contrast Sensitivity	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.	4 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Keratoconus; Scleral lens; Scleral lenses; Wavefront guided scleral lenses; Higher order aberrations; HOA scleral lenses; Sclerals; Higher order aberration correction; Custom scleral lenses; Wavefront guided; Irregular Astigmatism; WFG scleral lenses
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Refractive Errors; Astigmatism; Keratoconus; Corneal Wavefront Aberration
• Other Study ID Numbers: CLEI WFG Scleral Lens

Drug and device information, study documents

• 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