UMIN-CTR Clinical Trial

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

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