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

October 6, 2014 updated by: Zhi-zhong Ma, Peking University Third Hospital

Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: obervation
patients in this arm received 6-months observation alone after injury
Active Comparator: Surgical intervention
patients in this arm received vitrectomy surgery as soon as possible after injury
Procedure: vitrectomy surgery
"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
macular hole closure rate
Time Frame: 6 month after injury
6 month after injury

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Principal Investigator: Zhi-Zhong Ma, M.D., Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 28, 2011

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUTH-TMH-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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