Anterior Segment Spectral-domain Optical Coherence Tomogr... | NCT02638025

Studies
Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury

NCT02638025

Sponsor

Huizhou Municipal Central Hospital

Status

Completed

Last Update Posted

Dec 22, 2015Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Eye Injuries

Interventions

Countries

Not provided

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

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2015Actual

First Submitted Date

Dec 16, 2015

First Submission Date that Met QC Criteria

Dec 20, 2015

First Posted Date

Dec 22, 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

Dec 20, 2015

Last Update Posted Date

Dec 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 use anterior segment spectral-domain optical coherence tomography (SD-OCT) to exam patients with closed globe injury, and compared with slit lamp examination. The results showed that OCT can identify features of closed globe injury that were otherwise not visible on slit lamp biomicroscopy.

Detailed Description

The anterior segment architecture changes of closed globe injury patients include corneal damage, hyphema, angle recession and lens dislocation, which can be showed with OCT. OCT was superior to slit lamp biomicroscopy examination in detecting anterior segment architecture changes, especially in the presence of media opacities.

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

16Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OCT	Device	Anterior Segment Spectral-domain Optical Coherence Tomography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anterior segment spectral-domain optical coherence tomography (SD-OCT) findings in patients with closed globe injury		within 24 hours after patients were admitted

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with closed globe injury were recruited; had hyphema at least 1/3 of anterior chamber volume

Exclusion Criteria:

can not cooperate with examination

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with closed globe injury were recruited, and all eyes of recruited patients had hyphema occupying at least 1/3rd of anterior chamber volume

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D005131	Eye Injuries

Ancestor Terms

ID	Term
D005151	Facial Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided