NCT01243931

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Jun 2011Dec 2026

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
15.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

15.5 years

First QC Date

November 18, 2010

Last Update Submit

February 8, 2024

Conditions

Corneal Opacity

Keywords

Phototherapeutic keratectomyOptical coherence tomographyCorneal opacityCorneal dystrophy

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months post-procedure

Secondary Outcomes (1)

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

    12 months post-procedure

Study Arms (1)

Surgery

EXPERIMENTAL

OCT is assisting in surgery guidance.

Drug: OCT-guided laser phototherapeutic keratectomy

Interventions

OCT-guided laser phototherapeutic keratectomyDRUG

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.

Also known as: Manufacturer/Name OCT Technology 510(K), Optovue/RTVue-CAM Fourier-domain K071250, Bioptigen/Bioptigen Fourier-domain K063343, Zeiss/Visante Time-domain K051789
Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Corneal OpacityCorneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • David Huang, MD, PhD

    Casey Eye Institute, Oregon Health & Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Humberto Martinez, COT

CONTACT

503-494-7712martinhu@ohsu.edu

Denny Romfh, OD

CONTACT

503-494-4351romfhd@ohsu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
: David Huang, MD, PhD, Professor of Ophthalmology

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

June 1, 2011

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

US(1)