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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhi-zhong Ma, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT01509092
First received: December 28, 2011
Last updated: October 6, 2014
Last verified: January 2012
  Purpose

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.


Condition Intervention
Trauma
Macular Hole
Procedure: vitrectomy surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial

Further study details as provided by Peking University Third Hospital:

Primary Outcome Measures:
  • macular hole closure rate [ Time Frame: 6 month after injury ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • central foveal thickness [ Time Frame: 6 month after hole closure ] [ Designated as safety issue: No ]
  • length of inner-segment outer-segment junction defect [ Time Frame: 6 month after hole closure ] [ Designated as safety issue: No ]
  • final visual acuity [ Time Frame: 6 month after hole closure ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2012
Study Completion Date: June 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509092

Locations
China, Hebei
Eye Hospital of Hebei Province
Xingtai, Hebei, China
China, Shandong
Weifang Eye Hospital
Weifang, Shandong, China
China, Zhejiang
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Wenzhou Medical College
Wenzhou, Zhejiang, China
China
Peking University Third Hospital
Beijing, China
China - Japan Friendship 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
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Principal Investigator: Zhi-Zhong Ma, M.D. Peking University Third Hospital
  More Information

No publications provided

Responsible Party: Zhi-zhong Ma, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01509092     History of Changes
Other Study ID Numbers: PekingUTH-TMH-2011
Study First Received: December 28, 2011
Last Updated: October 6, 2014
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Peking University Third Hospital:
traumatic macular hole
vitrectomy
observation

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014