UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between central macular thickness and visual outcome after successful macular hole surgery
Title of the study (Brief title)	Corelation between central macular thickness and visual outcome after macular hole surgery
Region	Japan

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

Objectives
Narrative objectives1	To evaluate whether central retinal thickness (CRT) at 1 month after surgery can be used to predict final visual outcome in eyes with idiopathic macular holes (MH).
Basic objectives2	Others
Basic objectives -Others	clinical availability
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	correlation between central retinal thickness and best-corrected visual acuity at 1 year after surgery
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	50 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases of macular hole diagnosed with a slit lamp examination and optic coherence tomography.
Key exclusion criteria	secondary macular hole, myopic eyes with a refractive error greater than -8.0 diopters, the history of ocular surgery and inflamation, the presence of other ocular diseases, intraoperative complications, cases with a long duration of preoperative symptoms exceeding 12 months, severe catgaract(more than greade 4 for any tyoe of cataract) by the LOCS III (lens opacity classification system)classification.
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshihiro Takamura
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Department of Ophthalmology
Address	23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL	0776-61-8403
Email	ytakamura@hotmail.com

Public contact
Name of contact person	Yoshihiro Takamura
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Department of Ophthalmology
Address	23-3 Shimoaiduki Matsuoka Eiheiji Yoshida Fukui
TEL	0776-61-8403
Homepage URL
Email	ytakamura@hotmail.com

Sponsor
Institute	Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
Institute
Department

Funding Source
Organization	Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
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	2012 Year 02 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 12 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2013 Year 10 Month 01 Day
Date of closure to data entry	2013 Year 11 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	prospective study

Management information
Registered date	2012 Year 02 Month 14 Day
Last modified on	2017 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008580