Observational Study of Corneal Opacities in Adults | NCT02109471

Studies
Observational Study of Corneal Opacities in Adults

NCT02109471

Sponsor

Oregon Health and Science University

Status

Unknown status

Last Update Posted

Feb 12, 2024Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Corneal Opacities (Scar and Stromal Dystrophy)

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01EY018184	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Jan 14, 2014

First Submission Date that Met QC Criteria

Apr 7, 2014

First Posted Date

Apr 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2024

Last Update Posted Date

Feb 12, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Huang, David Huang, MD, PhD, Professor of Ophthalmology, Oregon Health and Science University, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Name	Class
National Eye Institute (NEI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Label	Type	Description	Intervention Names
corneal opacities

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	2 years

Secondary Outcomes

Measure	Description	Time Frame
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.	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Humberto Martinez, COT	Contact	503-494-7712		martinhu@ohsu.edu
Denzil Romfh, OD	Contact	503-494-4351		romfhd@ohsu.edu

Overall Officials

Name	Affiliation	Role
David Huang, MD, PhD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Humberto Martinez	Recruiting	Portland	Oregon	97239	United States

Condition Browse Module

MeSH Terms

ID	Term
D003318	Corneal Opacity
D002921	Cicatrix

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases
D005355	Fibrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided