UMIN-CTR Clinical Trial

Basic information
Public title	Inverted internal limiting membrane flap technique for large macular hole
Acronym	Inverted internal limiting membrane flap technique for large macular hole
Scientific Title	Inverted internal limiting membrane flap technique for large macular hole
Scientific Title:Acronym	Inverted internal limiting membrane flap technique for large macular hole
Region	Japan

Condition
Condition	large macular hole
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess efficacy and safety of inverted internal limiting membrane flap technique in patients with large macular hole.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Closeure rate of macular hole
Key secondary outcomes	Best corrected visual acuity

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	Vitrectomy with inverted internal limiting membrane and 20% SF6 gas tamponade. Patients must keep prone position until macular hole closure and avoid supine position until intravitreous gas vanished.
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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	(1)20< years of age <85 (2)Be able to keep prone position (3)Written imformed consent
Key exclusion criteria	highly myopic eye (-6.0 diopter or less) those with an apparent retinal or choroidal diseases including diabetic retinoparhy, age-related macular degeneration, retinal vein occlusion and others those with a history of retinal surgery
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Taiji Middle name Last name Sakamoto
Organization	Kagoshima University
Division name	Ophthalmology
Zip code	8900075
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-5402
Email	tsakamot@m3.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	1st name Toshifumi Middle name Last name Yamashita
Organization	Kagoshima University
Division name	Ophthalmology
Zip code	8900075
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
TEL	099-275-5402
Homepage URL
Email	yyamatos@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Ophthalmology, Kagoshima University
Institute
Department

Funding Source
Organization	A grant from the Ministry of Health, Labor and Welfare, and by a Aid for Scientric Research from the Ministry of Education, Science, and Culture of the Japanese Government
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Kagoshima University Hospital
Address	8-35-1 Sakuragaoka, Kagoshima, Japan
Tel	099-275-5402
Email	kufsyomu@kuas.kagoshima-u.ac.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	鹿児島大学病院、Kagoshima University Hospital

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Completed
Date of protocol fixation	2012 Year 01 Month 01 Day
Date of IRB	2012 Year 03 Month 04 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2015 Year 11 Month 01 Day
Date of closure to data entry	2015 Year 11 Month 01 Day
Date trial data considered complete	2015 Year 11 Month 01 Day
Date analysis concluded	2015 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2012 Year 05 Month 15 Day
Last modified on	2021 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009355