An interventional study of Wavefront Guided Scleral Lenses and Traditional Scleral Lenses in Keratoconus, Irregular Astigmatism and Corneal Ectasia, sponsored by Cornea and Laser Eye Institute. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Cornea and Laser Eye Institute · Not applicable, Interventional, and Treatment
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.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Cornea and Laser Eye Institute is the lead sponsor of 10 studies on the registry; 3 are open to participants now.
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-A diagnosis of keratoconus or irregular astigmatism
Exclusion Criteria:
Scleral lenses with customized wavefront guided optics
Device: Wavefront Guided Scleral Lenses
Scleral lenses with traditional optics
Device: Traditional Scleral Lenses
Custom wavefront guided, higher order aberration correcting scleral lenses
Also known as: ARES Scleral Lenses
Traditional scleral lenses
Also known as: CS Scleral Lenses
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Cornea and Laser Eye Institute