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NCT Number: NCT01509092

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

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.

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Key information

Conditions

Trauma Eye Diseases Macular Hole Retinal Diseases Retinal Perforations Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Hospital of Hebei Province, Xingtai, Hebei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

vitrectomy surgery

Procedure

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

Primary outcomes

  1. macular hole closure rate

    Time frame: 6 month after injury

Secondary outcomes

  1. central foveal thickness

    Time frame: 6 month after hole closure

  2. length of inner-segment outer-segment junction defect

    Time frame: 6 month after hole closure

  3. final visual acuity

    Time frame: 6 month after hole closure

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 12, 2012
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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