What side effects are associated with this type of intervention?

Common treatments for myopia include corrective lenses (glasses or contact lenses), orthokeratology (overnight corneal reshaping lenses), and refractive surgery (such as LASIK). Corrective lenses generally have minimal side effects, though contact lenses can sometimes cause dry eyes, irritation, or infection if not properly maintained. Orthokeratology can lead to temporary discomfort, risk of infection, and corneal staining. Refractive surgery carries risks such as dry eyes, glare, halos, and potential complications from the surgery itself. Novel spectacle lenses, like those studied in recent trials, aim to control myopia progression and are generally well-tolerated, though specific side effects are not well-documented yet.

What prior FDA approvals exist?

The FDA has approved various treatments for myopia, including corrective lenses such as spectacles and contact lenses, which work by altering the way light enters the eye to focus it correctly on the retina. Additionally, orthokeratology (Ortho-K) lenses, which are worn overnight to temporarily reshape the cornea, have been approved. Pharmacological treatments like atropine eye drops, which slow the progression of myopia in children by relaxing the eye's focusing mechanism, are also FDA-approved. These treatments aim to manage and correct the refractive error associated with myopia, similar to the novel spectacle lens being studied in the referenced trial.

What other types of research exist?

Promising novel alternatives for treating myopia in 2024 include: 1) Novel spectacle lenses designed to control myopia progression, currently validated in clinical trials. 2) Low-dose atropine eye drops, which have shown efficacy in slowing myopia progression in children. 3) Orthokeratology (Ortho-K) lenses, which temporarily reshape the cornea to reduce myopia. 4) Multifocal contact lenses, which help in controlling the progression of myopia. 5) Lifestyle modifications such as increased outdoor activities and reduced near work, which have been associated with slower myopia progression.

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Device

Novel Spectacle Lenses for Myopia (EUCALYPTUS Trial)

N/A

Recruiting

Research Sponsored by SightGlass Vision, Inc.

Eligibility Criteria Checklist

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

Must have

Children 6 - 8 years of age (inclusive) at time of informed consent/assent

Be younger than 18 years old

Must not have

Current or prior use of bifocals, progressive addition spectacle lenses

Amblyopia in either eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment to see how well it works for younger children. The study will look at results over time to predict how effective the treatment will be in the long term. The trial involves multiple sites to ensure accurate results.

Who is the study for?

This trial is for children aged 6-8 with mild to moderate near-sightedness (myopia) who have good vision with glasses and no more than a small difference in prescription between their eyes. They must be able to wear the study glasses at least 10 hours a day, not use contact lenses, and have no eye conditions or systemic diseases affecting vision.

What is being tested?

The study tests if special spectacle lenses can control worsening myopia in young children compared to regular single-vision lenses. It's a masked study where neither participants nor observers know which type of lens each child gets, randomly assigning kids into two groups equally.

What are the potential side effects?

Since this trial involves wearing different types of spectacle lenses, there are minimal side effects expected. However, some discomfort or adjustment issues may occur when switching from previous eyewear to the test spectacles.

Eligibility Criteria

Inclusion Criteria

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

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My child is between 6 and 8 years old.

Exclusion Criteria

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

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I currently use or have used bifocals or progressive glasses.

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I have a 'lazy eye'.

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I have used treatments to control nearsightedness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Spherical equivalent refraction

Secondary study objectives

Axial length

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Test Arm 2Experimental Treatment1 Intervention

Single vision, impact-resistant spectacle lenses

Group II: Test Arm 1Experimental Treatment1 Intervention

Single vision, impact-resistant spectacle lenses

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

Common treatments for myopia, or nearsightedness, include corrective lenses, orthokeratology, and pharmacological treatments. Corrective lenses, such as glasses or contact lenses, work by refocusing light directly onto the retina, thereby improving vision clarity. Orthokeratology involves wearing specially designed rigid contact lenses overnight to temporarily reshape the cornea, reducing myopia during the day. Pharmacological treatments, like low-dose atropine eye drops, slow the progression of myopia by relaxing the eye's focusing mechanism and reducing eye elongation. These treatments are crucial for myopia patients as they not only improve vision but also help in managing the progression of the condition, potentially reducing the risk of severe complications like retinal detachment or glaucoma.

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