Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

NCT ID: NCT01243931

Last Updated: 2024-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2026-12-31

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.

Conditions

Corneal Opacity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery

OCT is assisting in surgery guidance.

Group Type: EXPERIMENTAL

OCT-guided laser phototherapeutic keratectomy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Manufacturer/Name OCT Technology 510(K); Optovue/RTVue-CAM Fourier-domain K071250; Bioptigen/Bioptigen Fourier-domain K063343; Zeiss/Visante Time-domain K051789

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

David Huang

: David Huang, MD, PhD, Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Casey Eye Institute, Oregon Health & Science University

Locations

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Humberto Martinez, COT

Role: CONTACT

martinhu@ohsu.edu

503-494-7712

Denny Romfh, OD

Role: CONTACT

romfhd@ohsu.edu

503-494-4351

Facility Contacts

Humberto Martinez, COT

Role: primary

martinhu@ohsu.edu

503-494-7712

Denny Romfh, OD

Role: backup

romfhd@ohsu.edu

503-494-4351

Other Identifiers

R01EY018184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU IRB #00006612-PTK

Identifier Type: -

Identifier Source: org_study_id