OrthoK Lenses for Myopia Progression

Phase 2

Waitlist Available

Research Sponsored by Illinois College of Optometry

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Must not have

History of any type of trauma or ocular surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is investigating whether orthokeratology (ortho-k) lenses, which are worn at night and change the corneal topography to correct low to moderate amounts of myopia, can also help slow axial elongation (which leads to degenerative changes like retinal detachment, glaucoma, and vitreal degeneration) in young adults.

Who is the study for?

This trial is for young adults aged 21-30 who are first-year optometry students with mild to moderate nearsightedness (myopia) and no serious eye conditions. Participants must be able to sleep at least six hours nightly, have good overall health, and commit to all necessary follow-up appointments.

What is being tested?

The study tests if wearing orthokeratology (ortho-k) lenses at night can slow down the worsening of myopia in young adults. These specialty lenses reshape the cornea temporarily to correct vision.

What are the potential side effects?

Potential side effects from using ortho-k lenses include discomfort or irritation in the eyes, risk of infection, temporary visual disturbances like glare or halos, especially when adapting to lens wear.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have had eye surgery or an eye injury in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: OrthoKExperimental Treatment1 Intervention

OrthoK lenses will be prescribed for subjects randomly and followed for 2yrs throughout wearing the lenses. There will be an enrollment appointment, dispense appointment, 1-day, 1-week, 1-month, 6-month, 12-month, and 24-month follow-ups.

Group II: ControlPlacebo Group1 Intervention

Subjects in the randomly assigned control will continue to wear their glasses throughout the 2yr follow-up period. There will be an enrollment appointment, 6-month, 12-month, and 24-month follow-ups.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OrthoK

2017

N/A

~50

0 / 1Eligibility criteria met