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Procedure

OCT-Guided Phototherapeutic Keratectomy for Corneal Opacity

N/A
Recruiting
Led By David Huang, MD, PhD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with vision primarily limited by superficial opacities and irregularities that could be removed by PTK while leaving at least 250 µm.
Be older than 18 years old
Must not have
Cataracts, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery
Inability to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether using an OCT machine to guide a laser results in better vision for patients with corneal scars or defects.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort in the eye, temporary visual disturbances, sensitivity to light, and a risk of infection or inflammation post-procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My vision issues can potentially be corrected by a specific eye surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an eye condition that could affect my vision after surgery.
Select...
I am unable to understand and agree to the study's details.
Select...
I have deep clouding and unevenness in my cornea.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK
Secondary study objectives
Improvement in uncorrected visual acuity (UCVA), refractive error, and higher order aberrations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SurgeryExperimental Treatment1 Intervention
OCT is assisting in surgery guidance.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,892 Total Patients Enrolled
5 Trials studying Corneal Opacity
655 Patients Enrolled for Corneal Opacity
National Eye Institute (NEI)NIH
554 Previous Clinical Trials
1,407,252 Total Patients Enrolled
5 Trials studying Corneal Opacity
221 Patients Enrolled for Corneal Opacity
David Huang, MD, PhD5.01 ReviewsPrincipal Investigator - Casey Eye Institute, Oregon Health & Science University
Oregon Health and Science University
10 Previous Clinical Trials
2,847 Total Patients Enrolled
1 Trials studying Corneal Opacity
150 Patients Enrolled for Corneal Opacity

Media Library

OCT-guided laser phototherapeutic keratectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT01243931 — N/A
Corneal Opacity Research Study Groups: Surgery
Corneal Opacity Clinical Trial 2023: OCT-guided laser phototherapeutic keratectomy Highlights & Side Effects. Trial Name: NCT01243931 — N/A
OCT-guided laser phototherapeutic keratectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01243931 — N/A
~10 spots leftby Dec 2026
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