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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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04698590
Acronym
WFG Sclerals
Enrollment
100
Registered
2021-01-07
Start date
2021-01-15
Completion date
2025-12-31
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

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.

Interventions

DEVICEWavefront Guided Scleral Lenses

Custom wavefront guided, higher order aberration correcting scleral lenses

DEVICETraditional Scleral Lenses

Traditional scleral lenses

Sponsors

Cornea and Laser Eye Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Higher order aberration4 weeksTotal 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

MeasureTime frameDescription
Visual Acuity4 weeksVisual 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 Sensitivity4 weeksContrast 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026