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Procedure

Photorefractive Keratectomy for Lazy Eye

N/A
Waitlist Available
Led By Evelyn Paysse, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children aged 2 to 17 with significant anisometropia or isoametropia and amblyopia that have failed traditional treatment for at least 6 months.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial will investigate whether PRK can help improve the longterm visual acuity in children who have not responded to standard therapy for high anisometropia or isoametropia.

Who is the study for?
This trial is for children aged 2 to 17 with severe anisometropia or isoametropia and lazy eye (amblyopia) who haven't improved after at least 6 months of standard treatment. They must have a significant difference in vision between eyes or high near-sightedness, farsightedness, or astigmatism. Kids with certain corneal issues, collagen disorders, previous herpes infections in the eye, or very thin corneas can't join.Check my eligibility
What is being tested?
The study tests Photorefractive Keratectomy (PRK), a laser eye surgery that has helped adults correct vision problems like near-sightedness and astigmatism for over three decades. The goal is to see if PRK can also improve long-term vision in kids with amblyopia due to high refractive errors when other treatments fail.See study design
What are the potential side effects?
Potential side effects of PRK may include discomfort or pain post-surgery, light sensitivity, glare or halos around lights, dry eyes, and less commonly changes in cornea shape leading to blurry vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child, aged 2-17, has vision issues not improved by standard treatments for 6+ months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Visual acuity
Secondary outcome measures
Corneal clarity
Refractive error

Trial Design

1Treatment groups
Experimental Treatment
Group I: Photorefractive keratectomyExperimental Treatment1 Intervention
The children will undergo PRK in the affected eye(s) using previously derived formulas for PRK.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Photorefractive keratectomy
2006
N/A
~40

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
997 Previous Clinical Trials
6,001,819 Total Patients Enrolled
Evelyn Paysse, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

Photorefractive Keratectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03610997 — N/A
Near-sightedness Research Study Groups: Photorefractive keratectomy
Near-sightedness Clinical Trial 2023: Photorefractive Keratectomy Highlights & Side Effects. Trial Name: NCT03610997 — N/A
Photorefractive Keratectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03610997 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals allowed to participate in this trial?

"This trial has a narrow scope of qualification, which is limited to patients aged 2-17. However, there are 24 other trials for those below 18 and 40 separate studies open to those above 65 years old."

Answered by AI

Are there any participants being accepted into this research program?

"Based on the information sourced from clinicaltrials.gov, this particular medical trial is no longer recruiting subjects for participation. It was originally posted January 1st 2001 and last modified on January 19th 2022; however, there are 78 other trials currently enlisting participants at present."

Answered by AI

Are there any criteria for people to be eligible to participate in this trial?

"This research study is seeking 200 youth between the ages of 2 and 17 with hyperopia who have not responded to traditional treatments for a duration of at least 6 months. The prerequisite criteria include, but are not limited to: isoametropic group; myopia -4.00 diopters in each eye; hyperopia +4.00 diopters in both eyes; astigmatism +2.50 diopters in both eyes; anisometropia 3+ dioptres; best corrected visual acuity two lines lower on amblyopic eye than fellow eye (in verbal children)."

Answered by AI
~31 spots leftby Aug 2028