Study of Surgery in Patients With Idiopathic Macular Hole
NCT ID: NCT02905409
Last Updated: 2019-12-30
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
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UNKNOWN
PHASE4
228 participants
INTERVENTIONAL
2016-08-31
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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4PD diameter of ILM peeling in surgery
Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI\<0.5, 0.5≤MHCI\<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 4PD (papillary diameter) group, patients were given 4PD diameter of ILM (internal limiting membrane) peeling in surgery.
ILM peeling surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)
2PD diameter of ILM peeling in surgery
Patients were stratified according to the macular hole closure index(MHCI) measured by OCT into 3 subgroup (MHCI\<0.5, 0.5≤MHCI\<0.7, MHCI≥0.7 ). And then randomized into 2 different intervention groups. If randomized into 2PD (papillary diameter) group, patients were given 2PD diameter of ILM (internal limiting membrane) peeling in surgery.
ILM peeling surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)
Interventions
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ILM peeling surgery
4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)
Eligibility Criteria
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Inclusion Criteria
* patients signed the ICF
* patients with course of IMH less than 3 years
Exclusion Criteria
* patients with traumatic macular hole
* accompanied or secondary of other fundus disease
* open or reopen after receiving MH surgery
* patients with retinal detachment
* received vitrectomy due to other diseases
* glaucoma cannot be controled by medication
* patients with other retinal or choroidal disease that may affect VA
* poor patients compliance
* poor condition that cannot undertake the surgery
* dioptric media opacities which make it difficult to exam fundus or measure on OCT
50 Years
80 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Beijing Hospital
OTHER_GOV
Peking Union Medical College Hospital
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Mingwei Zhao
Head of Opthalmology Department, Principal Investigator, Clinical Professor
Principal Investigators
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Mingwei Zhao, M.D
Role: STUDY_DIRECTOR
Peking University People's Hospital
Hong Dai, M.D
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College
Wenbin Wei, M.D
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital of Capital Medical University
Youxin Chen, M.D
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College
Locations
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People's Hospital of Peking University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Minwei Zhao, M.D
Role: primary
Other Identifiers
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ILMIMH-CHINA
Identifier Type: -
Identifier Source: org_study_id