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CompletedNCT01509092Updated Oct 7, 2014

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

An interventional study of vitrectomy surgery in Trauma and Macular Hole, sponsored by Peking University Third Hospital. Completed at 8 sites in China. Per ClinicalTrials.gov, last updated 2014-10-07.

Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Trauma
  • Macular Hole

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Keywords

  • traumatic macular hole
  • vitrectomy
  • observation
03

In context

Retinal Perforations

156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.

This study's enrollment of 44 is close to the median of 44 across 104 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • 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

Interventions

  • Procedurevitrectomy surgery

    "pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole

06

What researchers measure

Primary outcomes

  1. macular hole closure rate

    Time frame: 6 month after injury

Secondary outcomes

  1. central foveal thickness

    Time frame: 6 month after hole closure

  2. length of inner-segment outer-segment junction defect

    Time frame: 6 month after hole closure

  3. final visual acuity

    Time frame: 6 month after hole closure

07

Study locations

8 sites
  • Eye Hospital of Hebei Province
    Xingtai, Hebei, China
  • Weifang Eye Hospital
    Weifang, Shandong, China
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
  • Wenzhou Medical College
    Wenzhou, Zhejiang, China
  • China - Japan Friendship Hospital
    Beijing, China
  • Peking University Third Hospital
    Beijing, China
  • Southwest Eye hospital of Third Military Medical University
    Chongqing, China
  • Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine
    Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01509092
Lead sponsor
Peking University Third Hospital
Responsible party
Zhi-zhong Ma (Professor, Peking University Third Hospital) — Principal investigator
First posted
Jan 12, 2012
Start date
Jan 2012
Primary completion
Feb 2014
Completion
Jun 2014
Last update
Oct 7, 2014

Study contacts

Zhi-Zhong Ma, M.D.
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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