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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-procedure
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My vision issues can potentially be corrected by a specific eye surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK
Secondary outcome measures
Improvement in uncorrected visual acuity (UCVA), refractive error, and higher order aberrations
Trial Design
1Treatment groups
Experimental Treatment
Group I: SurgeryExperimental Treatment1 Intervention
OCT is assisting in surgery guidance.
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Who is running the clinical trial?
Oregon Health and Science UniversityLead Sponsor
978 Previous Clinical Trials
7,386,424 Total Patients Enrolled
5 Trials studying Corneal Opacity
655 Patients Enrolled for Corneal Opacity
National Eye Institute (NEI)NIH
547 Previous Clinical Trials
1,401,963 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My vision issues can potentially be corrected by a specific eye surgery.I have an eye condition that could affect my vision after surgery.I am unable to understand and agree to the study's details.I have deep clouding and unevenness in my cornea.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current scope of recruitment for this experiment?
"Affirmative. Clinicaltrials.gov shows that the experiment is still open for recruitment, with its initial posting date being June 1st 2011 and last updated on September 20th 2022. The research requires 80 participants to be sourced from one site in total."
Answered by AI
Are there any open enrolment opportunities in this experiment?
"Affirmative, the details published on clinicaltrials.gov affirms that this trial is actively looking for volunteers. The study was first announced in June 2011 and most recently revised in September 2022- it seeks to enrol 80 patients from a single centre."
Answered by AI
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