Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01243931|
Recruitment Status : Recruiting
First Posted : November 19, 2010
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Corneal Opacity||Drug: OCT-guided laser phototherapeutic keratectomy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
OCT is assisting in surgery guidance.
Drug: OCT-guided laser phototherapeutic keratectomy
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.
- Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK [ Time Frame: 3-4, 6-8, and 12-14 months after the PTK 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.
- Improvement in uncorrected visual acuity (UCVA), refractive error, and higher order aberrations [ Time Frame: 3-4, 6-8, and 12-14 months after the PTK 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243931
|Contact: Omkar Thaware, B Optom, MSVSemail@example.com|
|Contact: Denny Romfh, ODfirstname.lastname@example.org|
|United States, Oregon|
|Casey Eye Institute, Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Omkar Thaware, B Optom, MSVS 503-494-7398 email@example.com|
|Contact: Denny Romfh, OD 503-494-4351 firstname.lastname@example.org|
|Principal Investigator: David Huang, MD, PhD|
|Sub-Investigator: Winston Chamberlain, MD, PhD|
|Sub-Investigator: Afshan Nanji, MD|
|Sub-Investigator: John Clements, MD|
|Sub-Investigator: Lorinna Lombardi, MD|
|Sub-Investigator: Seema Gupta, MD|
|Sub-Investigator: Ellen Davis, MD|
|Sub-Investigator: Yan Li, PhD|
|Sub-Investigator: Maolong Tang, PhD|
|Sub-Investigator: Xinbo Zhang, PhD|
|Principal Investigator:||David Huang, MD, PhD||Casey Eye Institute, Oregon Health & Science University|