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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01509092
Enrollment
44
Registered
2012-01-12
Start date
2012-01-31
Completion date
2014-06-30
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Hole, Trauma

Keywords

traumatic macular hole, vitrectomy, observation

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.

Interventions

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

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
macular hole closure rate6 month after injury

Secondary

MeasureTime frame
central foveal thickness6 month after hole closure
length of inner-segment outer-segment junction defect6 month after hole closure
final visual acuity6 month after hole closure

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026