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

Location

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 Disease	Intervention/Treatment	Phase
Keratoconus Irregular Astigmatism Corneal Ectasia Aberration, Corneal Wavefront Wavefront Aberration, Corneal Pellucid Marginal Corneal Degeneration Keratoglobus	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

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

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

Outcome Measures

Primary Outcome Measures

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

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.
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.