Comparative Study Between Early Vitrectomy and Observation for Spontaneous Closure of Traumatic Macular Hole
NCT ID: NCT01509092
Last Updated: 2014-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
44 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
NCT00485199
Study of Surgery in Patients With Idiopathic Macular Hole
NCT02905409
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
NCT01229657
Early Vitrectomy for Impending Macular Hole
NCT01121965
Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
NCT03433547
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
obervation
patients in this arm received 6-months observation alone after injury
No interventions assigned to this group
Surgical intervention
patients in this arm received vitrectomy surgery as soon as possible after injury
vitrectomy surgery
"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
vitrectomy surgery
"pars plana vitrectomy +internal limiting membrane peeling" done immediately after the identification of the macular hole
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* identification of full-thickness macular hole by optical coherence tomography within one month after trauma
Exclusion Criteria
* 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)
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peking University Third Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhi-zhong Ma
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhi-Zhong Ma, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University Third Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eye Hospital of Hebei Province
Xingtai, Hebei, China
Weifang Eye Hospital
Weifang, Shandong, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Wenzhou Medical College
Wenzhou, Zhejiang, China
China - Japan Friendship Hospital
Beijing, , 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PekingUTH-TMH-2011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.