Comparative Study Between Early Vitrectomy and Observatio... | NCT01509092

Studies
Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole

NCT01509092

Sponsor

Peking University Third Hospital

Status

Completed

Last Update Posted

Oct 7, 2014Estimated

Enrollment

44Actual

Phase

Not Applicable

Conditions

Trauma
Macular Hole

Interventions

vitrectomy surgery

Countries

China

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

Jan 2012

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 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

Dec 28, 2011

First Submission Date that Met QC Criteria

Jan 9, 2012

First Posted Date

Jan 12, 2012Estimated

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 6, 2014

Last Update Posted Date

Oct 7, 2014Estimated

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

The purpose of this study is to compare the anatomical and visual recovery of eyes with traumatic macular hole (TMH) following either early vitrectomy or 6-month observation.

Detailed Description

Patients who received vitrectomy immediately after the injury were compared with patients who were observed for six months for spontaneously closure.The closure rate, foveal microstructure, and final visual acuity were analyzed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
obervation	No Intervention	patients in this arm received 6-months observation alone after injury
Surgical intervention	Active Comparator	patients in this arm received vitrectomy surgery as soon as possible after injury	Procedure: vitrectomy surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitrectomy surgery	Procedure	"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole	Surgical intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
macular hole closure rate		6 month after injury

Secondary Outcomes

Measure	Description	Time Frame
central foveal thickness		6 month after hole closure
length of inner-segment outer-segment junction defect		6 month after hole closure
final visual acuity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

closed globe injury
identification of full-thickness macular hole by optical coherence tomography within one month after trauma

Exclusion Criteria:

open globe injury
coexistence of idiopathic macular hole
severe opaque in the visual axis caused by the injury(eg. severe cataract, severe vitreous hemorrhage)
combined injuries requiring immediate surgical intervention (eg. lens dislocation, retinal detachment, cyclodialysis)
coexistence of high myopia
coexistence of choroidal rupture or subretinal hemorrhage within the diameter of 400μm from the center of the foveola
coexistence of severe optic nerve injury (no light perception, positive afferent pupillary defect)

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhi-Zhong Ma, M.D.	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye Hospital of Hebei Province		Xingtai	Hebei		China
Weifang Eye Hospital

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D012167	Retinal Perforations

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided