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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Photorefractive Keratectomy (PRK), a laser eye surgery, can improve vision in children with "lazy eye" (amblyopia) who haven't responded to standard treatments. PRK already corrects vision problems like nearsightedness and farsightedness in adults, so researchers aim to determine if it can assist children with severe vision differences between their eyes or similar severe issues in both eyes. Children aged 2 to 17 with such vision problems, who haven't improved after six months of regular treatment, might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore a new application of an existing treatment, potentially benefiting children who have not found success with other options.

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 prior data suggests that photorefractive keratectomy is safe for children with amblyopia?

Research has shown that photorefractive keratectomy (PRK) is a safe procedure for treating vision problems. In children with severe vision issues, such as anisometropic amblyopia (where one eye is weaker than the other), PRK significantly improves vision over time. Studies indicate that it leads to long-lasting vision improvement and enhances the eye's ability to focus light.

PRK has been used in adults for over 35 years, providing extensive information about its safety. In adults with amblyopia ("lazy eye"), PRK has improved vision and may even enhance binocular vision. Although some short-term side effects, like discomfort or changes in vision, can occur, these typically resolve as the eye heals.

Overall, PRK is well-tolerated and has a strong safety record in both adults and children, making it a promising option for children who haven't had success with other treatments for amblyopia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Photorefractive Keratectomy (PRK) is unique because it offers a surgical approach to treating lazy eye, unlike traditional methods like patching or atropine drops that focus on strengthening the weaker eye. PRK reshapes the cornea in the affected eye, potentially improving vision directly through physical change rather than just compensatory measures. Researchers are excited about PRK because it may provide a more permanent solution by addressing the structural issues of the eye, offering hope for lasting visual correction.

What evidence suggests that photorefractive keratectomy might be an effective treatment for amblyopia?

Research has shown that photorefractive keratectomy (PRK) effectively treats vision issues like nearsightedness, farsightedness, and astigmatism in adults for over 35 years. Studies indicate that about 70% of PRK patients achieve 20/20 vision, and 92% experience significantly better vision after surgery. Although this trial focuses on children, previous research has demonstrated that refractive surgery can be safe and effective for kids with unequal vision in their eyes. PRK has also shown promise in improving vision in adults with lazy eye. These findings suggest that PRK could effectively treat lazy eye in children who do not respond to standard treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Evelyn Paysse, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16360207/

Long-term outcomes of photorefractive keratectomy for ... Five (63%) of 8 myopic children achieved a refraction within 2 D of the target refraction. Two (67%) of 3 hyperopic patients maintained their refractions within ...

2. parkavenuelasek.com parkavenuelasek.com/amblyopia-lazy-eye-old/amblyopia-research/

We Have Fixed Hundreds Of Lazy Eyes Results from our study show that in adults with amblyopia, correction of refractive error with LASEK successfully improves the BCVA in the amblyopic eye.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9792104/

Ten-Year Outcomes of LASIK for Pediatric Myopic ... Conclusion. LASIK appears safe, effective, and stable for correcting refractory pediatric myopic anisometropia, in which conventional measures ...

4. gweye.com gweye.com/blog/2015/03/16/the-success-rates-of-prk-156123/

The Success Rates of PRK Surgery ... It's estimated that around 70% of PRK patients will achieve 20/20 vision after they undergo surgery; an estimated 92% of PRK patients achieve 20 ...

5. journals.lww.com journals.lww.com/aamj/fulltext/2024/01000/visual_and_sensory_outcomes_after_refractive.3.aspx

Visual and sensory outcomes after refractive surgery for... Refractive surgery is safe and effective for pediatric anisometropia treatment. LASIK has better visual outcomes and ICL has more preserved outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35156869/

Visual outcomes of photorefractive keratectomy in non- ... Results: The mean preoperative CDVA was 0.34 ± 0.24 LogMAR which showed a statistically significant improvement at 12 months (0.20 ± 0.19, p = ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939404000881

safety and impact on refractive error, visual acuity, and ... Photorefractive keratectomy for severe anisometropic amblyopia in children resulted in long-term stable reduction in refractive error and improvement in VA and ...

8. aaojournal.org aaojournal.org/article/S0161-6420(06)00294-6/fulltext

PRK and Amblyopia The authors concluded that adults with amblyopia have, “possibly, better binocular function” after refractive surgery.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37876510/

Evaluation of the efficiency and safety of TransPRK and FS ... Results: In the transPRK group, SEQ improved significantly after 1 month, from 2.08 ± 2.02D (p<0.01) to 0.125 ± 0.86D and at the 12 month visit to -0.04 ± 0.62D ...

10. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/11206721211073033

Visual outcomes of photorefractive keratectomy in non- ... Objective. To evaluate the safety, efficiency, short term stability, and sensory results of photorefractive keratectomy (PRK) in anisometropic ...