Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

Part of paid clinical trials in Portland, Oregon.

Sponsor
Oregon Health and Science University
Study ID
NCT01243931
Status
Recruiting

Conditions

  • Corneal Opacity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2011
Status verified
Feb 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Surgery
    OCT is assisting in surgery guidance.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Casey Eye Institute, Oregon Health & Science UniversityPortlandOregon97239
Humberto Martinez, COT
503-494-7712
Denny Romfh, OD
503-494-4351
David Huang, MD, PhD (PRINCIPAL_INVESTIGATOR)
Winston Chamberlain, MD, PhD (SUB_INVESTIGATOR)
Afshan Nanji, MD (SUB_INVESTIGATOR)
Richard Stutzman, MD (SUB_INVESTIGATOR)
Seema Gupta, MD (SUB_INVESTIGATOR)
Ellen Davis, MD (SUB_INVESTIGATOR)
Yan Li, PhD (SUB_INVESTIGATOR)

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