UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035091
Receipt No. R000040004
Official scientific title of the study Temporal Inverted Internal Limiting Membrane Flap Technique for refractory Macular Holes
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Temporal Inverted Internal Limiting Membrane Flap Technique for refractory Macular Holes
Title of the study (Brief title) Temporal Inverted ILM Flap Technique
Region
Japan

Condition
Condition Macular hole
Classification by specialty
Nephrology Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy of temporal inverted internal limiting membrane flap technique for macular holes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The final rate of macular hole closure
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria refractory MHs, including large MHs (minimal diameter, over 400 micro meter), chronic MHs (symptomatic duration, over 24 months), MHs in high myopia (axial length, over 26 mm), and MHs in patients who could not maintain postoperative prone positioning after vitrectomy
Key exclusion criteria Patients with a history of retinal surgery, retinal detachment, diabetic retinopathy, retinal vascular occlusion, uveitis, and trauma were excluded.
Target sample size 40

Research contact person
Name of lead principal investigator Yasuyuki Takai
Organization Shimane university
Division name Ophthalmology
Address Enya 89-1, Izumo, Shimane
TEL 0853-20-2284
Email takai611@med.shimane-u.ac.jp

Public contact
Name of contact person Yasuyuki Takai
Organization Shimane university
Division name Ophthalmology
Address Enya89-1, Izumo, Shimane
TEL 0853-20-2284
Homepage URL
Email takai611@med.shimane-u.ac.jp

Sponsor
Institute Shimane university
Institute
Department

Funding Source
Organization Shimane university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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 12 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2014 Year 02 Month 01 Day
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Partially published
URL releasing results
Results
Other related information The MHs closed successfully in all (100%) eyes postoperatively in 20 refractory macular hole patients.

Management information
Registered date
2018 Year 11 Month 30 Day
Last modified on
2018 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040004

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.