Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole
Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial
1 other identifier
interventional
44
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 7, 2014
January 1, 2012
2.1 years
December 28, 2011
October 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
macular hole closure rate
6 month after injury
Secondary Outcomes (3)
central foveal thickness
6 month after hole closure
length of inner-segment outer-segment junction defect
6 month after hole closure
final visual acuity
6 month after hole closure
Study Arms (2)
obervation
NO INTERVENTIONpatients in this arm received 6-months observation alone after injury
Surgical intervention
ACTIVE COMPARATORpatients in this arm received vitrectomy surgery as soon as possible after injury
Interventions
"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole
Eligibility Criteria
You may qualify if:
- closed globe injury
- identification of full-thickness macular hole by optical coherence tomography within one month after trauma
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhi-Zhong Ma, M.D.
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2011
First Posted
January 12, 2012
Study Start
January 1, 2012
Primary Completion
February 1, 2014
Study Completion
June 1, 2014
Last Updated
October 7, 2014
Record last verified: 2012-01