UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of retinal transplantation for intractable macular hole
Title of the study (Brief title)	Retinal transplantation for intractable macular hole
Region	Japan

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

Objectives
Narrative objectives1	We will investigate the effectiveness and safety of retinal transplantation for refractory macular holes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sex, age, visual acuity, visual field, refraction, corneal curvature radius, corneal thickness, ocular axial length, fundus observation,Optical coherence tomography, optical coherence tomography angiography, fundus photograph, fluorescence fundus angiography, slit lamp microscopy, duration of disease, current medical history, past history, family history,
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Intervention by surgical technique.
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	Patients diagnosed as refractory macular hole between April 15, 2017 and December 15, 2020
Key exclusion criteria	nothing special
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroki Kaneko
Organization	Nagoya University Hospital
Division name	Department of Ophthalmology
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	0527442275
Email	h-kaneko@med.nagoya-u.ac.jp

Public contact
Name of contact person	Hiroki Kaneko
Organization	Nagoya University Hospital
Division name	Department of Ophthalmology
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	0527442275
Homepage URL
Email	h-kaneko@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Self-procurement
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 04 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 15 Day
Anticipated trial start date	2017 Year 04 Month 15 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 28 Day
Last modified on	2017 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030708