NCT Number: NCT01243931
Optical Coherence Tomography (OCT) machines are non-contact instruments that can measure the depth of scars and other causes of cloudiness in the front of the cornea. The purpose of this study is to determine whether OCT-guided settings for the lasers used for removal of corneal scars and other partial-thickness corneal defects result in improved vision in patients receiving these procedures.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
Location status: Recruiting
Afshan Nanji, MD
SUB_INVESTIGATOR
David Huang, MD, PhD
PRINCIPAL_INVESTIGATOR
Denny Romfh, OD
CONTACT
Ellen Davis, MD
SUB_INVESTIGATOR
Humberto Martinez, COT
CONTACT
Richard Stutzman, MD
SUB_INVESTIGATOR
Seema Gupta, MD
SUB_INVESTIGATOR
Winston Chamberlain, MD, PhD
SUB_INVESTIGATOR
Yan Li, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Manufacturer/Name OCT Technology 510(K), Optovue/RTVue-CAM Fourier-domain K071250, Bioptigen/Bioptigen Fourier-domain K063343, Zeiss/Visante Time-domain K051789
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)
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)
Contact information is provided by the study sponsor or research team.
Denny Romfh, OD
CONTACT
Humberto Martinez, COT
CONTACT
Oregon Health and Science University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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