NCT04698590: WFG Sclerals

Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism

Active, enrolled NA Last updated 3 May 2024

What this trial tests

NA trial testing Wavefront Guided Scleral Lenses in Keratoconus in 100 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 January 2021

Primary endpoint
31 January 2025

31 December 2025

Quick facts

Lead sponsor	Cornea and Laser Eye Institute
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	15 January 2021
Primary completion	31 January 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Wavefront Guided Scleral Lenses
• Traditional Scleral Lenses

Conditions studied

• Keratoconus — all drugs for Keratoconus →
• Irregular Astigmatism — all drugs for Irregular Astigmatism →
• Corneal Ectasia — all drugs for Corneal Ectasia →
• Aberration, Corneal Wavefront — all drugs for Aberration, Corneal Wavefront →

Sponsor

Cornea and Laser Eye Institute

Who can join

18 and older, any sex, with Keratoconus or Irregular Astigmatism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.