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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033723
Receipt No. R000038425
Scientific Title Clinical Outcomes of a Multicenter Study of Endoscope-Assisted Vitrectomy for Patients with Rhegmatogenous Retinal Detachment
Date of disclosure of the study information 2018/08/13
Last modified on 2020/08/12

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Basic information
Public title Clinical Outcomes of a Multicenter Study of Endoscope-Assisted Vitrectomy for Patients with Rhegmatogenous Retinal Detachment
Acronym Clinical Outcomes of a Multicenter Study of Endoscope-Assisted Vitrectomy for Rhegmatogenous Retinal Detachment
Scientific Title Clinical Outcomes of a Multicenter Study of Endoscope-Assisted Vitrectomy for Patients with Rhegmatogenous Retinal Detachment
Scientific Title:Acronym Clinical Outcomes of a Multicenter Study of Endoscope-Assisted Vitrectomy for Rhegmatogenous Retinal Detachment
Region
Japan

Condition
Condition Rhegmatogenous Retinal Detachment
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the utility of the ophthalmic endoscope by investigating a multicenter study of the clinical outcomes of endoscope-assisted vitrectomy for patients with rhegmatogenous retinal detachment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary success rate at postoperative 6 months
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Evaluate the clinical outcomes up to 6 months after surgery for patients who have undergone endoscope-assisted vitrectomy for treatment of rhegmatogenous retinal detachment.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with rhegmatogenous retinal detachment who are indication of vitrectomy
Key exclusion criteria Eyes with macular hole, giant retinal tears of >90 degrees, grade C proliferative vitreoretinopathy, dense vitreous hemorrhage that precluded the assessment of retinal breaks and retinal detachment preoperatively, proliferative diabetic retinopathy, familial exudative vitreoretinopathy, RD secondary to retinal vein occlusion, atopic dermatitis or uveitis, previous vitreoretinal surgery, or a history of previous RD surgery
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Tatsushi
Middle name
Last name Kaga
Organization Japan Community Healthcare Organization Chukyo Hospital
Division name Ophthalmology
Zip code 457-8510
Address 1-1-10 sanjo, minamiku, Nagoya city, Aichi, Japan
TEL 0526917151
Email kaga@chukyogroup.jp

Public contact
Name of contact person
1st name Sho
Middle name
Last name Yokoyama
Organization Japan Community Healthcare Organization Chukyo Hospital
Division name Ophthalmology
Zip code 457-8510
Address 1-1-10 sanjo, minamiku, Nagoya city, Aichi, Japan
TEL 0526917151
Homepage URL
Email yokoyama@chukyogroup.jp

Sponsor
Institute Japan Community Healthcare Organization Chukyo Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Community Healthcare Organization Chukyo Hospital
Address 1-1-10 sanjo, minamiku, Nagoya city, Aichi, Japan
Tel 0526917151
Email rinrikanri@chukyo.jcho.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 08 Month 01 Day
Date of IRB
2018 Year 06 Month 28 Day
Anticipated trial start date
2018 Year 08 Month 13 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 11 Day
Last modified on
2020 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038425

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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