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NCT04698590 · ClinicalTrials.gov registry record · NA
Wavefront Guided Scleral Lenses for Keratoconus and Irregular Astigmatism
A NA study of Keratoconus and Pellucid Marginal Corneal Degeneration, sponsored by Cornea and Laser Eye Institute.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04698590 is a NA study of Keratoconus and Pellucid Marginal Corneal Degeneration that is active but no longer recruiting, run by Cornea and Laser Eye Institute. The registered enrollment target is 100 participants, below the 1,176-participant average among 21 other Keratoconus trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04698590, a NA study of Keratoconus and Pellucid Marginal Corneal Degeneration, is active but no longer recruiting, sponsored by Cornea and Laser Eye Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE Wavefront Guided Scleral Lenses
- DEVICE Traditional Scleral Lenses
Study Locations (1)
New Jersey
- Cornea and Laser Eye Institue - Hersh Vision Group - Teaneck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04698590
The ClinicalTrials.gov registry entry for NCT04698590 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,176-participant average among 21 other Keratoconus trials with a reported enrollment target (91% lower). The listed sponsor is Cornea and Laser Eye Institute, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Keratoconus appearing as the primary indexed condition, and to 2 interventions - of which Wavefront Guided Scleral Lenses is the first listed.
NCT04698590 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT04698590 about?
NCT04698590 is a clinical study titled "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 co...
What is the current status of trial NCT04698590?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-01-15. Estimated completion is 2025-12-31.
What conditions does trial NCT04698590 study?
This clinical trial studies the following conditions: Keratoconus, Pellucid Marginal Corneal Degeneration, Corneal Ectasia, Irregular Astigmatism, Aberration, Corneal Wavefront.
What interventions are being tested in trial NCT04698590?
The interventions under investigation include: Wavefront Guided Scleral Lenses (DEVICE), Traditional Scleral Lenses (DEVICE).
Who is sponsoring clinical trial NCT04698590?
This trial is sponsored by Cornea and Laser Eye Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04698590 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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