OCT-Guided Phototherapeutic Keratectomy for Corneal Opacity

Overseen By Denny Romfh, OD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Cataracts, Retinal disease, Glaucoma, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve vision for individuals with corneal opacities, or cloudy spots on the front of their eyes. Using a special machine called OCT (Optical Coherence Tomography), doctors can guide a laser more precisely to remove these cloudy areas. This procedure, known as OCT-guided laser phototherapeutic keratectomy, acts like a GPS for eye surgery, ensuring precise treatment. Individuals with vision problems primarily due to these cloudy spots, rather than other eye issues like cataracts or glaucoma, might be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment precision and outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that OCT-guided laser phototherapeutic keratectomy is safe for corneal opacity treatment?

Research has shown that OCT-guided laser treatment for corneal problems is generally safe. This procedure can effectively reduce or remove corneal scars, leading to clearer vision.

OCT-guided methods use imaging to direct the laser, enhancing accuracy. This precision helps protect surrounding tissues from damage. Patients have reported that the treatment is well-tolerated, with no major side effects noted in studies.

Overall, evidence suggests that this method is a safe option for those with corneal clouding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for corneal opacity, which often include traditional phototherapeutic keratectomy (PTK) or corneal transplantation, the OCT-guided phototherapeutic keratectomy uses advanced imaging technology to guide the laser surgery more precisely. This technique allows surgeons to accurately target the affected areas of the cornea, potentially reducing the risk of removing too much tissue and improving visual outcomes. Researchers are excited about this method because it could lead to faster recovery times and fewer complications, offering a more effective and safer alternative for patients with corneal opacity.

What evidence suggests that OCT-guided laser phototherapeutic keratectomy is effective for corneal opacity?

Research has shown that OCT-guided laser treatment, which participants in this trial will receive, can effectively improve vision by treating corneal opacities. This method uses advanced imaging to guide the laser, allowing for more precise removal of scarred tissue. Studies have found that patients who underwent this procedure often experienced better vision and consistent results. Long-term evidence suggests that the benefits of the treatment endure, providing ongoing improvements in vision. These findings support OCT-guided laser treatment as a reliable option for those with cloudy vision due to corneal opacity. ^{1 3 6 7 8}

Who Is on the Research Team?

David Huang, MD, PhD

Principal Investigator

Casey Eye Institute, Oregon Health & Science University

Are You a Good Fit for This Trial?

This trial is for individuals with vision problems due to superficial corneal opacities and irregularities that can be treated with PTK, leaving at least 250 µm of the cornea. It's not suitable for those who can't stay still for OCT imaging, commit to follow-up visits, have deep corneal issues, or other eye conditions like cataracts or glaucoma.

Inclusion Criteria

My vision issues can potentially be corrected by a specific eye surgery.

Exclusion Criteria

I have an eye condition that could affect my vision after surgery.

Inability to maintain stable fixation for OCT imaging

Inability to commit to required visits to complete the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

OCT is assisting in surgery guidance for phototherapeutic keratectomy (PTK) to treat corneal opacities

1 day

1 visit (in-person)

Follow-up

Participants are monitored for improvement in visual acuity and other outcomes post-procedure

12 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• OCT-guided laser phototherapeutic keratectomy

Trial Overview

The study tests if using OCT to guide laser settings improves vision in patients undergoing phototherapeutic keratectomy (PTK) for removing scars and defects on the front part of the cornea.

How Is the Trial Designed?

Group I: Surgery Experimental Treatment 1 Intervention

OCT is assisting in surgery guidance.

OCT-guided laser phototherapeutic keratectomy is already approved in United States for the following indications:

Approved in United States as Phototherapeutic Keratectomy for:

• Corneal scars and opacities
• Epithelial membrane dystrophy
• Irregular corneal surfaces due to Salzmann's nodular degeneration or keratoconus nodules
• Recurrent corneal erosions

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

Custom phototherapeutic keratectomy (CPK) is a safe and effective treatment for highly aberrated eyes, with 88% of patients achieving 20/30 vision or better after 1 year, indicating significant improvement in visual acuity.

The procedure showed no cases of corneal ectasia, highlighting its safety as a surgical alternative to more invasive options like penetrating keratoplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year follow-up of custom phototherapeutic keratectomy. Vinciguerra, P., Camesasca, FI.[2022]

In a study of 23 eyes from 21 patients, FD-OCT-guided phototherapeutic keratectomy (PTK) combined with photorefractive keratectomy (PRK) significantly improved uncorrected visual acuity (UCVA) from a mean of 0.79 to 0.45 and best spectacle-corrected visual acuity (BSCVA) from 0.57 to 0.28, indicating effective treatment for anterior corneal scarring.

The procedure demonstrated safety with no complications reported, and significant improvements in corneal topographic indices, suggesting enhanced corneal surface regularity and symmetry post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fourier-domain optical coherence tomography-guided phototherapeutic keratectomy for the treatment of anterior corneal scarring. Yang, YL., Jian, Q., Liu, B., et al.[2020]

In a study of 60 patients undergoing OCT-guided transepithelial phototherapeutic keratectomy (PTK) for anterior corneal scarring, best spectacle-corrected visual acuity (BSCVA) significantly improved from a mean of 0.77 logMAR preoperatively to 0.34 logMAR postoperatively over an average follow-up of 41 weeks.

The procedure also resulted in significant improvements in corneal topography indices, indicating effective treatment of corneal scarring, with only a small number of patients requiring further surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of optical coherence tomography-guided transepithelial phototherapeutic keratectomy for the treatment of anterior corneal scarring. Rush, SW., Matulich, J., Rush, RB.[2022]

Transepithelial phototherapeutic keratectomy (PTK) was shown to effectively reduce stromal irregularities in patients with post-LASIK complications, leading to smoother corneal surfaces and improved visual outcomes, as evidenced by a 95% subjective improvement in one patient.

Epithelial compensation can mask underlying stromal irregularities, making traditional topography-guided ablation less effective and potentially worsening the condition, highlighting the importance of transepithelial PTK in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved effectiveness of transepithelial PTK versus topography-guided ablation for stromal irregularities masked by epithelial compensation. Reinstein, DZ., Archer, TJ., Gobbe, M.[2022]

Intraoperative optical coherence tomography (OCT) successfully provided real-time imaging during excimer laser phototherapeutic keratectomy (PTK) in all eight patients, allowing for the assessment of corneal optical properties.

PTK significantly improved corneal transparency and reduced surface roughness, indicating its efficacy in treating superficial corneal opacities, although further studies are needed to determine the correlation of these changes with postoperative visual outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative changes in corneal structure during excimer laser phototherapeutic keratectomy (PTK) assessed by intraoperative optical coherence tomography. Siebelmann, S., Horstmann, J., Scholz, P., et al.[2018]

In a study involving 10 eyes of 8 children aged 9 to 17, OCT-guided transepithelial phototherapeutic keratectomy (PTK) was performed without any significant complications, demonstrating its safety in a pediatric population.

Post-surgery, there was a significant improvement in both uncorrected and best spectacle-corrected visual acuity, with 7 out of 10 eyes showing complete resolution of central corneal opacity, indicating the efficacy of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography-Guided Transepithelial Phototherapeutic Keratectomy for Central Corneal Opacity in the Pediatric Population. Rush, SW., Rush, RB.[2022]

In a study of 22 patients, OCT-guided transepithelial phototherapeutic keratectomy (PTK) significantly improved best spectacle-corrected visual acuity (BSCVA) from a mean of 0.82 to 0.40 after 4 months, with all patients gaining at least one line of vision improvement.

The procedure showed no complications and provided predictable refractive outcomes, indicating it is a safe and effective treatment for anterior corneal scarring associated with irregularities in the Bowman layer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography-guided transepithelial phototherapeutic keratectomy for the treatment of anterior corneal scarring. Rush, SW., Han, DY., Rush, RB.[2022]

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