UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY ON THE EFFICACY AND SAFETY OF THREE DIFFERENT SURGICAL PROCEDURES FOR CONJUNCTIVOCHALASIS
Title of the study (Brief title)	THE EFFICACY AND SAFETY OF THREE DIFFERENT SURGICAL PROCEDURES FOR CONJUNCTIVOCHALASIS
Region	Japan

Condition
Condition	conjunctivochalasis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to elucidate the efficacy and safety of three different surgical methods for conjunctivochalasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	he duration of procedure, complications, frequency of residual conjunctival folds, subjective tolerability of surgery, tear breakup time and subjective symptoms
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	cautery
Interventions/Control_2	tucking
Interventions/Control_3	resection and stitching
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	99 years-old >=
Gender	Male and Female
Key inclusion criteria	subjects having aged conjunctivochalasis accompanied with ocular discomfort including foreign body sensation, ocular pain, eyestrain and watery eye.
Key exclusion criteria	subjects who had ocular sergeries contact lens users subjects having any ocular surface diseases other than conjunctivochalasis and dry eye eye drops users subjects who don't consent in written form subjects who are ruled unfit to the entry to the study
Target sample size	60

Research contact person
Name of lead principal investigator	Seika Shimazaki-Den
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Op
Address	5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL	047-322-0151
Email	dens@tdc.ac.jp

Public contact
Name of contact person	Mutusmi Ishii
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Institutional Review Board
Address	5-11-13, Sugano, Ichikawa, Chiba, Japan
TEL	047-322-0151
Homepage URL
Email	mishii@tdc.ac.jp

Sponsor
Institute	Toko Dental College Ichikawa General Hospital
Institute
Department

Funding Source
Organization	Toko Dental College Ichikawa General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	東京歯科大学市川総合病院(千葉県）および両国眼科クリニック(東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 01 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2013 Year 12 Month 31 Day
Date of closure to data entry	2014 Year 06 Month 30 Day
Date trial data considered complete	2014 Year 06 Month 30 Day
Date analysis concluded	2014 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 11 Day
Last modified on	2017 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013084