WFG Sclerals: Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism
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.
|Condition or Disease||Intervention/Treatment||Phase|
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.
Arms and Interventions
|Active Comparator: WFG Scleral Lenses
Scleral lenses with customized wavefront guided optics
Device: Wavefront Guided Scleral Lenses
Custom wavefront guided, higher order aberration correcting scleral lenses
|Placebo Comparator: Traditional Scleral Lenses
Scleral lenses with traditional optics
Device: Traditional Scleral Lenses
Traditional scleral lenses
Primary Outcome Measures
- Higher order aberration [4 weeks]
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.
Secondary Outcome Measures
- Visual Acuity [4 weeks]
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.
- Contrast Sensitivity [4 weeks]
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.
-A diagnosis of keratoconus or irregular astigmatism
Patients with other visually significant ocular pathology.
Inability to apply or remove a scleral lens.
Contacts and Locations
|1||Cornea and Laser Eye Institue - Hersh Vision Group||Teaneck||New Jersey||United States||07666|
Sponsors and Collaborators
- Cornea and Laser Eye Institute
- Principal Investigator: John D Gelles, OD, The Cornea and Laser Eye Institute
Study Documents (Full-Text)None provided.
- CLEI WFG Scleral Lens