ClinicalTrials.Veeva

Menu

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

P

Peking University

Status

Completed

Conditions

Trauma
Macular Hole

Treatments

Procedure: vitrectomy surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT01509092
PekingUTH-TMH-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

obervation
No Intervention group
Description:
patients in this arm received 6-months observation alone after injury
Surgical intervention
Active Comparator group
Description:
patients in this arm received vitrectomy surgery as soon as possible after injury
Treatment:
Procedure: vitrectomy surgery

Trial contacts and locations

8

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems