Choroidal Thickness in Optic Neuropathy | NCT02382627

Studies
Choroidal Thickness in Optic Neuropathy

NCT02382627

Sponsor

University of Colorado, Denver

Status

Terminated

Last Update Posted

Oct 18, 2019Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Optic Nerve Disorders

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

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor enrollment

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Mar 2, 2015

First Submission Date that Met QC Criteria

Mar 6, 2015

First Posted Date

Mar 9, 2015Estimated

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

Oct 16, 2019

Last Update Posted Date

Oct 18, 2019Actual

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

This study plans to learn more about the thickness of the choroid in patients with optic neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. Patients are being asked to be in this research study because they have optic neuropathy and are receiving care at the University of Colorado Hospital.

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

2Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference of the subfoveal and parafoveal choroidal thickness in affected and unaffected eye of the same patient.		1 time

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

age greater than 18 years,
diagnosis of optic neuropathy,
willing and able to sign an informed consent.

Exclusion criteria:

steroid use within the past 4 weeks,
inability to cooperate with optical coherence tomography (OCT) testing,
relevant ocular comorbidities in the affected or unaffected eye, such as
- glaucoma,
- uveitis,
- optic nerve hypoplasia,
- age related macular degeneration,
- refractive error greater than 5 spherical diopters.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

200 patients with optic neuropathy seen in the ophthalmology or neuro-ophthalmology clinics at the University of Colorado will be enrolled in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Bennett, MD	303-724-6450	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Hospital		Aurora	Colorado	80045	United States

Condition Browse Module

MeSH Terms

ID	Term
D009901	Optic Nerve Diseases

Ancestor Terms

ID	Term
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided