Keratoconus Clinical Trial
— WFG ScleralsOfficial title:
Custom Anterior Surfacing of Scleral Lens for Vision Quality Improvement in Patients With Keratoconus or Irregular Astigmatism
Verified date | May 2024 |
Source | Cornea and Laser Eye Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Cornea and Laser Eye Institue - Hersh Vision Group | Teaneck | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Cornea and Laser Eye Institute |
United States,
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 |
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