Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism

Keratoconus Clinical Trial

— WFG Sclerals  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04698590
• Other study ID #: CLEI WFG Scleral Lens
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Cornea and Laser Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aberration, Corneal Wavefront
• Astigmatism
• Corneal Ectasia
• Corneal Wavefront Aberration
• Irregular Astigmatism
• Keratoconus
• Keratoglobus
• Pellucid Marginal Corneal Degeneration
• Wavefront Aberration, Corneal

Intervention

Device:
• Wavefront Guided Scleral Lenses
Custom wavefront guided, higher order aberration correcting scleral lenses
• Traditional Scleral Lenses
Traditional scleral lenses

Locations

Country	Name	City	State
United States	Cornea and Laser Eye Institue - Hersh Vision Group	Teaneck	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cornea and Laser Eye Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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