Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism

NCT04698590 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLEI WFG Scleral Lens
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Acuity

  4 weeks

• Contrast Sensitivity

  4 weeks

Study Arms (2)

WFG Scleral Lenses

ACTIVE COMPARATOR

Scleral lenses with customized wavefront guided optics

Device: Wavefront Guided Scleral Lenses

Traditional Scleral Lenses

PLACEBO COMPARATOR

Scleral lenses with traditional optics

Device: Traditional Scleral Lenses

Interventions

Wavefront Guided Scleral Lenses DEVICE

Custom wavefront guided, higher order aberration correcting scleral lenses

Also known as: ARES Scleral Lenses

WFG Scleral Lenses

Traditional Scleral Lenses DEVICE

Traditional scleral lenses

Also known as: CS Scleral Lenses

Traditional Scleral Lenses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of keratoconus or irregular astigmatism

You may not qualify if:

• Patients with other visually significant ocular pathology.
• Inability to apply or remove a scleral lens.

Sponsors & Collaborators

• Cornea and Laser Eye Institute: lead

Study Sites (1)

Cornea and Laser Eye Institue - Hersh Vision Group

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Keratoconus; Corneal Wavefront Aberration

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Refractive Errors

Study Officials

• John D Gelles, OD

  The Cornea and Laser Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 7, 2021
• Study Start: January 15, 2021
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

US (1)