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

Trial Summary

What is the purpose of this trial?

Optical Coherence Tomography (OCT) machines are non-contact instruments that can measure the depth of scars and other causes of cloudiness in the front of the cornea. The purpose of this study is to determine whether OCT-guided settings for the lasers used for removal of corneal scars and other partial-thickness corneal defects result in improved vision in patients receiving these procedures.

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 data supports the effectiveness of the treatment OCT-guided laser phototherapeutic keratectomy for corneal opacity?

Research shows that OCT-guided transepithelial phototherapeutic keratectomy (PTK) is effective for treating corneal opacity and scarring, with studies reporting positive visual and anatomical outcomes. This treatment is particularly beneficial for managing anterior corneal scarring and has shown improved effectiveness compared to other methods for certain corneal irregularities. ^{1 2 3 4 5}

Is OCT-guided phototherapeutic keratectomy safe for humans?

Research shows that phototherapeutic keratectomy (PTK), including OCT-guided versions, is generally safe for treating various corneal conditions, such as scarring and opacities, in both adults and children. ^{1 2 4 6 7}

How is OCT-guided phototherapeutic keratectomy different from other treatments for corneal opacity?

OCT-guided phototherapeutic keratectomy is unique because it uses optical coherence tomography (OCT) to guide the laser treatment, allowing for precise removal of corneal opacities while preserving healthy tissue. This approach offers real-time monitoring and customization, which is not available in traditional treatments. ^{1 2 4 5 6}

Research Team

David Huang, MD, PhD

Principal Investigator

Casey Eye Institute, Oregon Health & Science University

Eligibility Criteria

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 commit to required visits to complete the study

I am unable to understand and agree to the study's details.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Optical coherence tomography-guided transepithelial phototherapeutic keratectomy for the treatment of anterior corneal scarring. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes of optical coherence tomography-guided transepithelial phototherapeutic keratectomy for the treatment of anterior corneal scarring. [2022]

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

Improved effectiveness of transepithelial PTK versus topography-guided ablation for stromal irregularities masked by epithelial compensation. [2022]

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Intraoperative changes in corneal structure during excimer laser phototherapeutic keratectomy (PTK) assessed by intraoperative optical coherence tomography. [2018]

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

One-year follow-up of custom phototherapeutic keratectomy. [2022]

7. China pubmed.ncbi.nlm.nih.gov

Fourier-domain optical coherence tomography-guided phototherapeutic keratectomy for the treatment of anterior corneal scarring. [2020]