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

Primary Purpose

Keratoconus, Irregular Astigmatism, Corneal Ectasia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wavefront Guided Scleral Lenses
Traditional Scleral Lenses
Sponsored by
Cornea and Laser Eye Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Scleral lenses, Scleral lens, Wavefront guided scleral lenses, Higher order aberrations, HOA scleral lenses, Sclerals, Higher order aberration correction, Custom scleral lenses, Wavefront guided, Keratoconus, Irregular Astigmatism, WFG scleral lenses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cornea and Laser Eye Institue - Hersh Vision GroupRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

WFG Scleral Lenses

Traditional Scleral Lenses

Arm Description

Scleral lenses with customized wavefront guided optics

Scleral lenses with traditional optics

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 31, 2020
Last Updated
December 30, 2022
Sponsor
Cornea and Laser Eye Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04698590
Brief Title
Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism
Acronym
WFG Sclerals
Official Title
Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus or Irregular Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornea and Laser Eye Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus, Irregular Astigmatism, Corneal Ectasia, Aberration, Corneal Wavefront, Wavefront Aberration, Corneal, Pellucid Marginal Corneal Degeneration, Keratoglobus
Keywords
Scleral lenses, Scleral lens, Wavefront guided scleral lenses, Higher order aberrations, HOA scleral lenses, Sclerals, Higher order aberration correction, Custom scleral lenses, Wavefront guided, Keratoconus, Irregular Astigmatism, WFG scleral lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WFG Scleral Lenses
Arm Type
Active Comparator
Arm Description
Scleral lenses with customized wavefront guided optics
Arm Title
Traditional Scleral Lenses
Arm Type
Placebo Comparator
Arm Description
Scleral lenses with traditional optics
Intervention Type
Device
Intervention Name(s)
Wavefront Guided Scleral Lenses
Other Intervention Name(s)
ARES Scleral Lenses
Intervention Description
Custom wavefront guided, higher order aberration correcting scleral lenses
Intervention Type
Device
Intervention Name(s)
Traditional Scleral Lenses
Other Intervention Name(s)
CS Scleral Lenses
Intervention Description
Traditional scleral lenses
Primary Outcome Measure Information:
Title
Higher order aberration
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
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.
Time Frame
4 weeks
Title
Contrast Sensitivity
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BethAnn Furlong-Hibbert, BA
Phone
2018830505
Email
bfurlong-hibbert@vision-institute.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Lazar, BS
Phone
2018830505
Email
slazar@vision-institute.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D Gelles, OD
Organizational Affiliation
The Cornea and Laser Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cornea and Laser Eye Institue - Hersh Vision Group
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BethAnn Furlong-Hibbert, BA
Phone
201-883-0505
Email
bfurlong-hibbert@vision-institute.com
First Name & Middle Initial & Last Name & Degree
Stacey Lazar, BS
Phone
201-883-0505
Email
slazar@vision-institute.com
First Name & Middle Initial & Last Name & Degree
John D Gelles, OD

12. IPD Sharing Statement

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Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism

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