Actively Recruiting
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy for Corneal Opacity
Led by Oregon Health and Science University · Updated on 2024-02-12
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether using Optical Coherence Tomography (OCT) to guide laser settings during the removal of corneal scars and partial-thickness corneal defects can improve vision. The study focuses on patients with vision limited by superficial corneal opacities and irregularities that can be treated with phototherapeutic keratectomy (PTK). The project utilizes advanced Fourier-domain OCT technology to precisely measure corneal shape and guide surgery, aiming to restore vision by reshaping irregular corneas. The treatment involves OCT-guided laser phototherapeutic keratectomy, where preoperative OCT measurements help determine laser depth settings to remove anterior corneal opacities while preserving at least 250 microns of corneal stroma. The surgeon uses this detailed imaging to plan treatment parameters for precise removal. There is one experimental surgery arm using this OCT-assisted technique. Participants will undergo the PTK procedure guided by OCT data and will be followed for 12 months post-procedure. Researchers will assess improvements in best spectacle-corrected visual acuity (BSCVA) as the primary outcome, along with secondary measures including uncorrected visual acuity, refractive error, and higher order aberrations. The study includes regular visits for imaging and vision assessments to monitor outcomes and safety over the year following surgery.
CONDITIONS
Brief Title
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with vision primarily limited by superficial corneal opacities and irregularities that can be removed by phototherapeutic keratectomy while preserving at least 250 microns of corneal stroma
You will not qualify if you...
- Inability to give informed consent
- Inability to maintain stable fixation for OCT imaging
- Inability to commit to required study visits
- Presence of deep corneal opacities and irregularities
- Presence of cataracts, retinal disease, glaucoma, or other eye conditions that may limit visual outcome after surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo OCT-guided laser phototherapeutic keratectomy where high-speed OCT imaging guides the laser treatment to remove superficial corneal opacities while preserving corneal stroma.
1 surgical visit (in-person)
Duration - Up to 12 months
Participants are monitored for improvements in visual acuity and corneal healing after surgery.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Casey Eye Institute, Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
H
Humberto Martinez, COT
D
Denny Romfh, OD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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