OCT-Guided Phototherapeutic Keratectomy for Corneal Opacity

Recruiting in Palo Alto (17 mi)

Overseen by David Huang, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Oregon Health and Science University

Disqualifiers: Cataracts, Retinal disease, Glaucoma, others

No Placebo Group

Approved in 1 Jurisdiction

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Casey Eye Institute, Oregon Health & Science University Portland, OR

Who Is Running the Clinical Trial?

Oregon Health and Science University Lead Sponsor

National Eye Institute (NEI) Collaborator

References

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

Optical coherence tomography-guided transepithelial phototherapeutic keratectomy for the treatment of anterior corneal scarring. [2022] To report the visual and anatomic outcomes of a novel technique for the management of anterior corneal scarring using optical coherence tomography (OCT)-guided transepithelial phototherapeutic keratectomy (transepithelial PTK).

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] To report the long-term outcomes of optical coherence tomography (OCT)-guided transepithelial phototherapeutic keratectomy (PTK) for the management of anterior corneal scarring.

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] To demonstrate improved effectiveness of transepithelial phototherapeutic keratectomy (PTK) where topography-guided ablation is degraded by epithelial compensation for localized irregularities.

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

Optical Coherence Tomography-Guided Transepithelial Phototherapeutic Keratectomy for Central Corneal Opacity in the Pediatric Population. [2022] To report the outcomes of optical coherence tomography- (OCT-) guided transepithelial phototherapeutic keratectomy (PTK) for central corneal opacity in the pediatric population.

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] Excimer laser phototherapeutic keratectomy (PTK) is a safe treatment for superficial corneal opacities, e.g., in corneal dystrophies or degenerations. Nevertheless, no standardized treatment protocols are available and intraoperative monitoring was not possible, so far. Here we evaluate the potential benefits of the intraoperative assessment by microscope-integrated intraoperative optical coherence tomography (MI-OCT) of corneal optical properties during PTK.

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

One-year follow-up of custom phototherapeutic keratectomy. [2022] Phototherapeutic keratectomy is a safe and effective treatment for many superficial diseases of the cornea. We applied intraoperative, epithelium-free, topography-based corneal aberrometry as a basis for custom phototherapeutic keratectomy (CPK) in highly aberrated eyes with opacities or irregularities consequent to previous refractive treatment, ulcers, keratitis, trauma or corneal dystrophies.

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

Fourier-domain optical coherence tomography-guided phototherapeutic keratectomy for the treatment of anterior corneal scarring. [2020] To evaluate the safety, visual and anatomic outcomes of fourier-domain optical coherence tomography (FD-OCT)-guided excimer laser phototherapeutic keratectomy (PTK) combined with photorefractive keratectomy (PRK) surgery in treating anterior corneal scarring.