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RecruitingNCT02109471Updated Feb 12, 2024

Observational Study of Corneal Opacities in Adults

An observational study in Corneal Opacities (Scar and Stromal Dystrophy), sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-12.

Sponsored by Oregon Health and Science University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jun 2011; still recruiting 15 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 100 Years
Sex
All
01

Study summary

A prospective observational study on corneal opacities (scar and stromal dystrophy) in adults (n=150) will be conducted at OHSU. The Optovue anterior segment OCT will be used to perform 3-D corneal scans. These scans will be used to assess opacity depth and measure corneal thickness (pachymetry), corneal topography (anterior and posterior), and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imaging, will be performed for comparison.

02

Conditions studied

  • Corneal Opacities (Scar and Stromal Dystrophy)

Keywords

  • corneal opacities
  • Optical coherence tomography
03

In context

Corneal Opacity

37 studies on the registry are indexed under Corneal Opacity; 5 are open to participants now.

This study's planned enrollment of 150 is above the median of 45 across 14 observational studies indexed under Corneal Opacity.

Browse Corneal Opacity studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult (18 \& older) patients presenting in OHSU Casey Eye Clinic with corneal opacities (scar and stromal dystrophy)

Exclusion criteria

Exclusion Criteria:

  • Inability to give .
  • Inability to maintain stable fixation for OCT imaging.
  • Inability to commit to required visits to complete the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • corneal opacities
06

What researchers measure

Primary outcomes

  1. Identification of suitable subjects

    The primary goal of this observational study is to identify suitable subjects for the clinical trials of OCT-guided transepithelial PTK.

    Time frame: 2 years

Secondary outcomes

  1. Validate OCT topography

    A second goal is to validate OCT anterior topography by comparison with standard Placido-ring corneal topography and develop a mathematical model that relates epithelial thickness variation to corneal mean curvature.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Humberto Martinez
    Portland, Oregon 97239, United States
    Recruiting
    • Humberto Martinez, COT · Contactmartinhu@ohsu.edu · 503-494-7712
    • Denzil Romfh, OD · Contactromfhd@ohsu.edu · 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
    • Yan Li, PhD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2011 (actual). Primary completion is estimated for Dec 2025, 174 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2014
First posted
Apr 10, 2014
StartActual
Jun 2011
Primary completionEst.
Dec 2025
CompletionEst.
Dec 2025
Last update
Feb 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02109471
Responsible party
David Huang (David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health and Science University, Oregon Health and Science University) — Principal investigator
First posted
Apr 10, 2014
Start date
Jun 2011
Primary completion
Dec 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Feb 12, 2024

Study contacts

Humberto Martinez, COT
Contact
martinhu@ohsu.edu
503-494-7712
Denzil Romfh, OD
Contact
romfhd@ohsu.edu
503-494-4351
David Huang, MD, PhD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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