Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

ConditionCorneal Opacity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with vision primarily limited by superficial opacities and irregularities that could be removed by PTK while leaving at least 250 µm.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

OCT-guided laser phototherapeutic keratectomy
Drug
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.

Treatment groups

80 Participants

are divided into 1 treatment group

Group A: SurgeryExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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)

Time frame

12 months post-procedure

Secondary outcomes

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)

Time frame

12 months post-procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov

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