Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism

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

Sponsors

Lead Sponsor: Cornea and Laser Eye Institute

Source Cornea and Laser Eye Institute
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.

Overall Status Recruiting
Start Date January 15, 2021
Completion Date December 31, 2022
Primary Completion Date January 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Higher order aberration 4 weeks
Secondary Outcome
Measure Time Frame
Visual Acuity 4 weeks
Contrast Sensitivity 4 weeks
Enrollment 100
Condition
Intervention

Intervention Type: Device

Intervention Name: Wavefront Guided Scleral Lenses

Description: Custom wavefront guided, higher order aberration correcting scleral lenses

Arm Group Label: WFG Scleral Lenses

Other Name: ARES Scleral Lenses

Intervention Type: Device

Intervention Name: Traditional Scleral Lenses

Description: Traditional scleral lenses

Arm Group Label: Traditional Scleral Lenses

Other Name: CS Scleral Lenses

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
John D Gelles, OD Principal Investigator The Cornea and Laser Eye Institute
Overall Contact

Last Name: BethAnn Furlong-Hibbert, BA

Phone: 2018830505

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Cornea and Laser Eye Institue - Hersh Vision Group BethAnn Furlong-Hibbert, BA 201-883-0505 [email protected] John D Gelles, OD Principal Investigator
Location Countries

United States

Verification Date

January 2021

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: WFG Scleral Lenses

Type: Active Comparator

Description: Scleral lenses with customized wavefront guided optics

Label: Traditional Scleral Lenses

Type: Placebo Comparator

Description: Scleral lenses with traditional optics

Acronym WFG Sclerals
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov