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

Not Applicable

Completed

• Conditions: Trauma; Macular Hole
• Interventions: Procedure: vitrectomy surgery

• Registration Number: NCT01509092
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-12-28
• Status Verified: 2012-01
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Primary Completion: 2014-02
• Study Completion: 2014-06
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• closed globe injury
• identification of full-thickness macular hole by optical coherence tomography within one month after trauma

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical intervention	vitrectomy surgery	patients in this arm received vitrectomy surgery as soon as possible after injury

Primary Outcome Measures

Name	Time	Method
macular hole closure rate	6 month after injury

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Eye Hospital of Hebei Province; 🇨🇳 Xingtai, Hebei, China

Weifang Eye Hospital; 🇨🇳 Weifang, Shandong, China

Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, 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

China - Japan Friendship Hospital; 🇨🇳 Beijing, China