Photorefractive Keratectomy for Lazy Eye

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Corneal abnormality, Collagen disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

Duration: 1 day

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Photorefractive keratectomy (PRK) with excimer laser has been used successfully to treat myopia, hyperopia, and astigmatism in adults for over 35 years. Children with high refractive errors that go untreated will develop severe amblyopia. PRK can normalize high refractive errors and potentially improve the visual acuity in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Photorefractive Keratectomy for Lazy Eye?

Photorefractive keratectomy (PRK) has shown to improve visual acuity (sharpness of vision) in pediatric patients with refractive errors, including those with amblyopia (lazy eye), as seen in a study where all treated children experienced better vision and reduced need for glasses. ^{1 2 3 4 5}

Is photorefractive keratectomy (PRK) generally safe for humans?

Research shows that photorefractive keratectomy (PRK) is generally safe, with studies evaluating its safety and complication rates over many years. While these studies primarily focus on its use for correcting vision problems like myopia (nearsightedness), they provide valuable safety information for its use in humans. ^{6 7 8 9 10}

How is photorefractive keratectomy different from other treatments for lazy eye?

Photorefractive keratectomy (PRK) is unique because it uses a laser to reshape the cornea (the clear front part of the eye) to improve vision, which is different from traditional treatments for lazy eye that often involve eye patches or corrective lenses. PRK is typically used for correcting vision issues like nearsightedness, farsightedness, and astigmatism, making its application for lazy eye a novel approach. ^{1 11 12 13 14}

Research Team

Evelyn Paysse, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

My child, aged 2-17, has vision issues not improved by standard treatments for 6+ months.

If you have nearsightedness, it must be at least -4.00 diopters in both eyes. If you have farsightedness, it must be at least +4.00 diopters in both eyes. If you have astigmatism, it must be at least +2.50 diopters in both eyes.

One eye must have significantly different vision from the other eye, and the blurry eye must be much worse than the clear eye.

Exclusion Criteria

You have a history of eye problems that could make it difficult to improve your vision.

You have a history of a known collagen disorder.

I have a history of corneal ectasia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo photorefractive keratectomy (PRK) in the affected eye(s) using previously derived formulas

1 day

1 visit (in-person)

Follow-up

Participants are monitored for visual acuity, refractive error stability, and corneal health

10 years

Regular visits over 10 years

Treatment Details

Interventions

• Photorefractive Keratectomy

Trial Overview 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.

Participant Groups

Group I: Photorefractive keratectomy Experimental Treatment 1 Intervention

The children will undergo PRK in the affected eye(s) using previously derived formulas for PRK.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of photorefractive keratectomy retreatments after regressed myopic laser in situ keratomileusis. [2019]

2. China pubmed.ncbi.nlm.nih.gov

Therapeutic effects of undercorrection by LASIK following RK and PRK for correction of high myopia. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Photorefractive keratectomy retreatments: comparison of two methods of excimer laser epithelium removal. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Photorefractive keratectomy in pediatric patients. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[Photorefractive keratectomy in hypermetropia]. [2008]

6. France pubmed.ncbi.nlm.nih.gov

[Non-refractive complications of keratectomy with Excimer laser in 141 myopic eyes]. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Results and complications of laser in situ keratomileusis by experienced surgeons. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Excimer laser photorefractive keratectomy for low to moderate myopia using a 5.0 mm treatment zone and no transitional zone: 16-year follow-up. [2022]

9. England pubmed.ncbi.nlm.nih.gov

PRK Enhancement for Residual Refractive Error After Primary PRK: A Retrospective Study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Complications of excimer laser photorefractive keratectomy for myopia. [2022]

11. Brazil pubmed.ncbi.nlm.nih.gov

[Topographically-guided photorefractive keratectomy for the management of secondary hyperopia following radial keratectomy]. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Photorefractive keratectomy for the treatment of purely refractive accommodative esotropia: 6 years' experience. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Excimer laser keratectomy for astigmatism occurring after penetrating keratoplasty. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Time-delayed, two-step excimer laser photorefractive keratectomy to correct high myopia. [2007]