Recruiting

OCT Guided PTK

Sponsor:

Oregon Health and Science University

Code:

NCT01243931

Conditions

Corneal Opacity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OCT-guided laser phototherapeutic keratectomy

Study Details

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.

Conditions

Corneal Opacity

Study ID

NCT01243931

Start date

Jun, 2011

Status verified date

Feb, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surgery

OCT is assisting in surgery guidance.

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.

Primary outcome measure

  • Improvement in best spectacle-corrected visual acuity (BSCVA) after PTK [ Time Frame: 12 months post-procedure ]

Central Contacts and Locations

Central contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denny Romfh, OD

503-494-4351romfhd@ohsu.edu

Locations

Casey Eye Institute, Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Humberto Martinez, COT

503-494-7712martinhu@ohsu.edu

Denny Romfh, OD

503-494-4351romfhd@ohsu.edu

Principal Investigator:

David Huang, MD, PhD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Feb 12, 2024

Last verified

Feb, 2024

Keywords

  • Phototherapeutic keratectomy
  • Optical coherence tomography
  • Corneal opacity
  • Corneal dystrophy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-02-12.