Study of the Surgical Timing of Traumatic Macular Hole

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by Peking University Third Hospital
Sponsor:
Information provided by (Responsible Party):
Zhi-zhong Ma, Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT01509092
First received: December 28, 2011
Last updated: January 9, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to determine whether patient with traumatic macular hole should be observed for spontaneous closure of the hole or receive vitrectomy surgery at early time.


Condition Intervention
Traumatic Macular Hole
Procedure: vitrectomy surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Traumatic Macular Hole: Observation Versus Early Surgical Intervention, A Multicenter Randomized Controlled Trial

Further study details as provided by Peking University Third Hospital:

Primary Outcome Measures:
  • Change from Baseline in Best Corrected Visual Acuity [ Time Frame: 2week, 1month, 2month, 3month, 6month ] [ Designated as safety issue: No ]
  • Change from Baseline in Maximal Diameter of the Hole Shown on OCT [ Time Frame: 2week, 1month, 2month, 3month, 6month ] [ Designated as safety issue: No ]
  • Change from Baseline in Top Diameter of the Hole Shown on OCT [ Time Frame: 2week, 1month, 2month, 3month, 6month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: obervation
Active Comparator: Surgical intervention (vitrectomy surgery) Procedure: vitrectomy surgery
"PPV+ILM peeling" done immediately after the identification of the macular hole

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • closed globe injury
  • presence of full-thickness macular hole 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, APD+)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509092

Contacts
Contact: Hui-Jin Chen, Doctor 86-010-82266699 ext 6359 chjdoc@yahoo.cn

Locations
China, Guangdong
ZhongShan Eye Hospital Not yet recruiting
GuangZhou, Guangdong, China
Contact: Tang       drtang@yahoo.cn   
China, Zhejiang
Eye Hospital of WenZhou Medical school
WenZhou, Zhejiang, China
China
Tong Ren hospital Not yet recruiting
Beijing, China
Contact: wang       drwang@yahoo.cn   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
Principal Investigator: Zhi-Zhong Ma, Doctor Peking University Third Hospital
  More Information

No publications provided

Responsible Party: Zhi-zhong Ma, Professor, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT01509092     History of Changes
Other Study ID Numbers: PekingUTH-TMH-2011
Study First Received: December 28, 2011
Last Updated: January 9, 2012
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Peking University Third Hospital:
traumatic macular hole
vitrectomy
observation

Additional relevant MeSH terms:
Retinal Perforations
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014