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NCT01509092 Clinical Trial

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

Trauma Clinical Trial

Official title:
Traumatic Macular Hole: Six-months Observation Versus Early Surgical Intervention, A Multicenter Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01509092
Other study ID # PekingUTH-TMH-2011
Secondary ID
Status Completed
Phase N/A
First received December 28, 2011
Last updated October 6, 2014
Start date January 2012
Est. completion date June 2014

Study information
Verified date January 2012
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date June 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China China - Japan Friendship Hospital Beijing
China Peking University Third Hospital Beijing
China Southwest Eye hospital of Third Military Medical University Chongqing
China The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang
China Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University school of Medicine Shanghai
China Weifang Eye Hospital Weifang Shandong
China Wenzhou Medical College Wenzhou Zhejiang
China Eye Hospital of Hebei Province Xingtai Hebei

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary macular hole closure rate 6 month after injury No
Secondary central foveal thickness 6 month after hole closure No
Secondary length of inner-segment outer-segment junction defect 6 month after hole closure No
Secondary final visual acuity 6 month after hole closure No
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