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

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ClinicalTrials.gov Identifier: NCT01509092
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Zhi-zhong Ma, Peking University Third Hospital

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.

Condition or disease Intervention/treatment Phase
Trauma Macular Hole Procedure: vitrectomy surgery Not Applicable

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  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial
Study Start Date : January 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2014

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



Primary Outcome Measures :
  1. macular hole closure rate [ Time Frame: 6 month after injury ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Principal Investigator: Zhi-Zhong Ma, M.D. Peking University Third Hospital

Responsible Party: Zhi-zhong Ma, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01509092     History of Changes
Other Study ID Numbers: PekingUTH-TMH-2011
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: January 2012

Keywords provided by Zhi-zhong Ma, Peking University Third Hospital:
traumatic macular hole
vitrectomy
observation

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases