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

Primary Purpose

Trauma, Macular Hole

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vitrectomy surgery
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring traumatic macular hole, vitrectomy, observation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Eye Hospital of Hebei Province
  • Weifang Eye Hospital
  • The Second Affiliated Hospital Zhejiang University School of Medicine
  • Wenzhou Medical College
  • China - Japan Friendship Hospital
  • Peking University Third Hospital
  • Southwest Eye hospital of Third Military Medical University
  • Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

obervation

Surgical intervention

Arm Description

patients in this arm received 6-months observation alone after injury

patients in this arm received vitrectomy surgery as soon as possible after injury

Outcomes

Primary Outcome Measures

macular hole closure rate

Secondary Outcome Measures

central foveal thickness
length of inner-segment outer-segment junction defect
final visual acuity

Full Information

First Posted
December 28, 2011
Last Updated
October 6, 2014
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01509092
Brief Title
Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole
Official Title
Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Macular Hole
Keywords
traumatic macular hole, vitrectomy, observation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
obervation
Arm Type
No Intervention
Arm Description
patients in this arm received 6-months observation alone after injury
Arm Title
Surgical intervention
Arm Type
Active Comparator
Arm Description
patients in this arm received vitrectomy surgery as soon as possible after injury
Intervention Type
Procedure
Intervention Name(s)
vitrectomy surgery
Intervention Description
"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole
Primary Outcome Measure Information:
Title
macular hole closure rate
Time Frame
6 month after injury
Secondary Outcome Measure Information:
Title
central foveal thickness
Time Frame
6 month after hole closure
Title
length of inner-segment outer-segment junction defect
Time Frame
6 month after hole closure
Title
final visual acuity
Time Frame
6 month after hole closure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-Zhong Ma, M.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hospital of Hebei Province
City
Xingtai
State/Province
Hebei
Country
China
Facility Name
Weifang Eye Hospital
City
Weifang
State/Province
Shandong
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Name
China - Japan Friendship Hospital
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Southwest Eye hospital of Third Military Medical University
City
Chongqing
Country
China
Facility Name
Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine
City
Shanghai
Country
China

12. IPD Sharing Statement

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

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