- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01243931
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The long-term goal of this project is to utilize newly available very high-speed OCT technology to guide surgical treatments of corneas with superficial opacities and irregularities. OCT is well known for its exquisite resolution, but until recently it has not had sufficient speed to capture the shape of the cornea because of eye motion during OCT scanning. The development of Fourier-domain OCT (FD-OCT) technology has made the requisite speed possible.
Eyes with superficial opacities (corneal scars and stromal dystrophies) can be treated by phototherapeutic keratectomy (PTK). Currently, many surgeons rely on subjective slit-lamp impression of opacity depth to guide PTK and repeat slit-lamp examinations during surgery to determine if the opacity has been sufficiently reduced. Unpredictable hyperopic shifts can occur after PTK. The aim of this project is to develop methods for imaging the cornea with an FD-OCT system that will precisely measure corneal shape and use this information to guide surgery. Patients with irregularly shaped corneas could have their vision restored by reshaping the corneas with a procedure that combines the precision of OCT and lasers.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Denny Romfh, OD
- Phone Number: 503-494-4351
- Email: romfhd@ohsu.edu
Study Contact Backup
- Name: Humberto Martinez, COT
- Phone Number: 503-494-7712
- Email: martinhu@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Casey Eye Institute, Oregon Health & Science University
-
Contact:
- Denny Romfh, OD
- Phone Number: 503-494-4351
- Email: romfhd@ohsu.edu
-
Contact:
- Humberto Martinez, COT
- Phone Number: 503-494-7712
- Email: martinhu@ohsu.edu
-
Principal Investigator:
- David Huang, MD, PhD
-
Sub-Investigator:
- Winston Chamberlain, MD, PhD
-
Sub-Investigator:
- Afshan Nanji, MD
-
Sub-Investigator:
- Richard Stutzman, MD
-
Sub-Investigator:
- Yan Li, PhD
-
Sub-Investigator:
- Ellen Davis, MD
-
Sub-Investigator:
- Seema Gupta, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with vision primarily limited by superficial opacities and irregularities that could be removed by PTK while leaving at least 250 µm.
Exclusion Criteria:
- Inability to give informed consent
- Inability to maintain stable fixation for OCT imaging
- Inability to commit to required visits to complete the study
- Deep corneal opacities and irregularities
- Cataracts, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgery
OCT is assisting in surgery guidance.
|
Preoperative measurements from the OCT are used to assist the calculation in deciding the laser depth settings for removal of anterior corneal opacities and defects in the phototherapeutic PTK procedure.
The surgeon uses the OCT data to plan a range of treatment parameters to remove most of the opacity while preserving at least 250 microns of residual corneal stroma.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK
Time Frame: 12 months post-procedure
|
The primary goal of the trial is to determine the efficacy of the OCT-guided PTK treatment of corneal opacities.
During the course of the trial, we will compare the predictive accuracy of the original OCT-guided PTK planning system to the OCT topography-guided system.
BSCVA will be measured in typical Snellen acuity notation as 20/xx (feet)
|
12 months post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in uncorrected visual acuity (UCVA), refractive error, and higher order aberrations
Time Frame: 12 months post-procedure
|
A second goal is to develop a more sophisticated OCT guidance system incorporating OCT topography of anterior and posterior corneal surfaces and to develop a mathematical model that relates epithelial thickness variation to corneal mean curvature.
During the course of the trial, we will compare the predictive accuracy of the original OCT-guided PTK planning system to the OCT topography-guided system.
UCVA will be measured in typical Snellen acuity notation as 20/xx (feet)
|
12 months post-procedure
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Huang, MD, PhD, Casey Eye Institute, Oregon Health & Science University
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OHSU IRB #00006612-PTK
- R01EY018184 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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