Status:
COMPLETED
Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole
Lead Sponsor:
Peking University Third Hospital
Conditions:
Trauma
Macular Hole
Eligibility:
All Genders
Phase:
NA
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.
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 ...
Eligibility Criteria
Inclusion
- closed globe injury
- identification of full-thickness macular hole by optical coherence tomography within one month after trauma
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01509092
Start Date
January 1 2012
End Date
June 1 2014
Last Update
October 7 2014
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Eye Hospital of Hebei Province
Xingtai, Hebei, China
2
Weifang Eye Hospital
Weifang, Shandong, China
3
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
4
Wenzhou Medical College
Wenzhou, Zhejiang, China