UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized parallel-group trial for influence of upper and temporal transconjunctival sclerocorneal incision on marginal reflex distance after cataract surgery
Title of the study (Brief title)	Influence of position of transconjunctival sclerocorneal incision in marginal reflex distance after cataract surgery
Region	Japan

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

Objectives
Narrative objectives1	To compare the marginal reflex distance 1 (MRD1) preoperatively and postoperatively between the two different incision types during cataract srugery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Marginal reflex distance 1 (MRD1) preoperatively and at three months postoperatively
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Group for an upper 2.4-mm transconjunctival sclerocorneal incision during cataract operation
Interventions/Control_2	Group for a temporal 2.4-mm transconjunctival sclerocorneal incision during cataract operation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with cataract
Key exclusion criteria	Patients with a history of thyroid eye disease, proptosis, enophthalmos, or previous lid or ocular surgery
Target sample size	30

Research contact person
Name of lead principal investigator	Masahiro Zako
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 Karimata, Yazako, Nagakute, Aichi
TEL	0561623311
Email	Mzako@aol.com

Public contact
Name of contact person	Masahiro Zako
Organization	Aichi Medical University
Division name	Department of Ophthalmology
Address	1-1 Karimata, Yazako, Nagakute, Aichi
TEL	0561623311
Homepage URL	http://www.aichi-med-u.ac.jp/su06/su0611/su061100/__icsFiles/afieldfile/2013/11/01/rin_H25-06.pdf
Email	Mzako@aol.com

Sponsor
Institute	Aichi Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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	愛知医科大学病院（愛知県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 07 Day
Last follow-up date	2015 Year 10 Month 06 Day
Date of closure to data entry	2015 Year 11 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 01 Day
Date analysis concluded	2016 Year 01 Month 01 Day

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

Management information
Registered date	2016 Year 05 Month 14 Day
Last modified on	2016 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025704