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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WFG Scleral Lenses | Active Comparator | Scleral lenses with customized wavefront guided optics |
|
| Traditional Scleral Lenses | Placebo Comparator | Scleral lenses with traditional optics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wavefront Guided Scleral Lenses | Device | Custom wavefront guided, higher order aberration correcting scleral lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
-A diagnosis of keratoconus or irregular astigmatism
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John D Gelles, OD | The Cornea and Laser Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornea and Laser Eye Institue - Hersh Vision Group | Teaneck | New Jersey | 07666 | United States |
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| Traditional Scleral Lenses | Device | Traditional scleral lenses |
|
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| 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 |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D057108 | Corneal Wavefront Aberration |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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