What side effects are associated with this type of intervention?

Custom scleral lenses with wavefront guided optics, used to correct higher order aberrations, can significantly improve vision quality by masking corneal irregularities. Potential side effects include discomfort, difficulty in lens fitting, frequent adjustments, corneal hypoxia, infection, and mechanical irritation. These risks are generally manageable with proper fitting and hygiene practices.

What prior FDA approvals exist?

FDA-approved treatments for corneal wavefront aberrations primarily include specialty contact lenses, such as scleral lenses, which are designed to correct higher order aberrations (HOAs) caused by conditions like keratoconus or irregular astigmatism. These lenses help mask corneal irregularities and improve vision. Custom scleral lenses with wavefront guided optics are an advanced form of these lenses, aimed at further reducing residual HOAs and enhancing visual quality. While specific FDA approvals for these custom lenses are not detailed in the provided context, they represent a significant advancement in the management of corneal aberrations.

What other types of research exist?

Promising novel alternatives to custom scleral lenses with wavefront guided optics for corneal wavefront aberration patients in 2024 include: 1) Corneal collagen cross-linking combined with photorefractive keratectomy (PRK) to stabilize and reshape the cornea, 2) Implantable collamer lenses (ICLs) for correcting high refractive errors and reducing HOAs, 3) Topography-guided laser treatments that customize the ablation pattern based on the corneal surface, and 4) Intracorneal ring segments (ICRS) to improve corneal shape and reduce irregular astigmatism.

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Wavefront Guided Scleral Lenses for Keratoconus and Astigmatism (WFG Sclerals Trial)

N/A

Waitlist Available

Led By John D Gelles, OD

Research Sponsored by Cornea and Laser Eye Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

-A diagnosis of keratoconus or irregular astigmatism

A diagnosis of keratoconus or irregular astigmatism

Must not have

Patients with other visually significant ocular pathology

Inability to apply or remove a scleral lens.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Summary

This trial is testing special contact lenses for people with severe vision issues that regular lenses can't fix. These custom-made lenses use advanced eye measurements to improve vision quality by correcting specific distortions.

Who is the study for?

This trial is for individuals with keratoconus or irregular astigmatism, which are conditions that distort vision. Participants must be able to apply and remove scleral lenses themselves and should not have other major eye diseases affecting their sight.

What is being tested?

The study is comparing two types of contact lenses: Wavefront Guided Scleral Lenses designed to correct specific visual aberrations, versus Traditional Scleral Lenses that help improve vision but may not address all issues caused by higher order aberrations.

What are the potential side effects?

While the trial doesn't explicitly mention side effects, wearing scleral lenses typically can cause discomfort, redness, dry eyes or potential infection if not used properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with keratoconus or irregular astigmatism.

Select...

I have been diagnosed with keratoconus or irregular astigmatism.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an eye condition that significantly affects my vision.

Select...

I cannot put in or take out a scleral lens by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Higher order aberration

Secondary study objectives

Contrast Sensitivity

Visual Acuity

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: WFG Scleral LensesActive Control1 Intervention

Scleral lenses with customized wavefront guided optics

Group II: Traditional Scleral LensesPlacebo Group1 Intervention

Scleral lenses with traditional optics

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Custom scleral lenses with wavefront guided optics are designed to correct higher order aberrations (HOAs) that standard glasses and soft contact lenses cannot address. These lenses work by masking the irregularities of the cornea, thereby reducing visual distortions such as halos, glare, and starbursts. The wavefront guided optics further refine this correction by tailoring the lens to the specific aberrations of the individual eye, leading to improved visual clarity. This is particularly important for patients with conditions like keratoconus or irregular astigmatism, where traditional corrective methods fall short, thus significantly enhancing their quality of vision and daily life.