search
Back to results

Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

Primary Purpose

Corneal Opacity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OCT-guided laser phototherapeutic keratectomy
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Opacity focused on measuring Phototherapeutic keratectomy, Optical coherence tomography, Corneal opacity, Corneal dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Casey Eye Institute, Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgery

Arm Description

OCT is assisting in surgery guidance.

Outcomes

Primary Outcome Measures

Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK
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)

Secondary Outcome Measures

Improvement in uncorrected visual acuity (UCVA), refractive error, and higher order aberrations
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)

Full Information

First Posted
November 18, 2010
Last Updated
September 20, 2022
Sponsor
Oregon Health and Science University
Collaborators
National Eye Institute (NEI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01243931
Brief Title
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
Official Title
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Opacity
Keywords
Phototherapeutic keratectomy, Optical coherence tomography, Corneal opacity, Corneal dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Experimental
Arm Description
OCT is assisting in surgery guidance.
Intervention Type
Drug
Intervention Name(s)
OCT-guided laser phototherapeutic keratectomy
Other Intervention Name(s)
Manufacturer/Name OCT Technology 510(K), Optovue/RTVue-CAM Fourier-domain K071250, Bioptigen/Bioptigen Fourier-domain K063343, Zeiss/Visante Time-domain K051789
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK
Description
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
Secondary Outcome Measure Information:
Title
Improvement in uncorrected visual acuity (UCVA), refractive error, and higher order aberrations
Description
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)
Time Frame
12 months post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Humberto Martinez, COT
Phone
503-494-7712
Email
martinhu@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Denny Romfh, OD
Phone
503-494-4351
Email
romfhd@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Huang, MD, PhD
Organizational Affiliation
Casey Eye Institute, Oregon Health & Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casey Eye Institute, Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humberto Martinez, COT
Phone
503-494-7712
Email
martinhu@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Denny Romfh, OD
Phone
503-494-4351
Email
romfhd@ohsu.edu
First Name & Middle Initial & Last Name & Degree
David Huang, MD, PhD
First Name & Middle Initial & Last Name & Degree
Winston Chamberlain, MD, PhD
First Name & Middle Initial & Last Name & Degree
Afshan Nanji, MD
First Name & Middle Initial & Last Name & Degree
Richard Stutzman, MD
First Name & Middle Initial & Last Name & Degree
Seema Gupta, MD
First Name & Middle Initial & Last Name & Degree
Ellen Davis, MD
First Name & Middle Initial & Last Name & Degree
Yan Li, PhD

12. IPD Sharing Statement

Learn more about this trial

Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

We'll reach out to this number within 24 hrs