UMIN-CTR Clinical Trial

Basic information
Public title	Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study.
Acronym	Corneal shape changes of total and posterior corneas after nasal versus temporal clear corneal incisions.
Scientific Title	Surgically induced changes in astigmatism and shape of total and posterior cornea after nasal versus temporal clear corneal incision (CCI) cataract surgery: a prospective randomized clinical study.
Scientific Title:Acronym	Corneal shape changes of total and posterior corneas after nasal versus temporal clear corneal incisions.
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to compare surgically induced astigmatism (SIA) and shape changes of total and posterior cornea between eyes that underwent nasal clear corneal incisions (CCI) and eyes that underwent temporal CCI in cataract surgery.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Patients are to undergo examinations at 2 days and at 2, 4, and 8 weeks after surgery. 1) Corneal astigmatism of anterior and posterior corneas (simulated K value of a videokeratography system; Tomey TMS-5) 2) Corneal shape changes of anterior and posterior cornea (average of difference map of TMS-5)
Key secondary outcomes	3) Irregular astigmatism components (asymmetry and higher-order irregularity components) 4) Ocular higher order aberrations (HOAs) 5) Visual acuity and refractive status 6) Wound length and width 7) Pupil diameter 8) Surgical factors

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	One hundred left eyes of 100 patients with with-the-rule astigmatism of 0.5 D or less were randomly assigned to one of the two groups.
Interventions/Control_2	50 eyes were to undergo nasal CCI and 50 eyes were to undergo temporal CCI.
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	One hundred left eyes of 100 patients with with-the-rule astigmatism of 0.5 D or less.
Key exclusion criteria	Exclusion criteria were 1) eyes with any pathology of cornea, optic nerve, and macula; 2) eyes with lens nucleus harder than grade 4 according to the Lens Opacities Classification System III; 3) eyes with a poor mydriasis less than 4.5 mm; 4) eyes with possible zonular weakness, 5) eyes with pseudoexfoliation; 6) eyes with prior history of ocular surgery and inflammation, 7) patients with diabetes; 8) patients who were referred from other hospitals, and 9) patients who had been enrolled in other studies
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of ophthalmology
Zip code
Address	4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL	092-431-1680
Email	hayashi-ken@hayashi.or.jp

Public contact
Name of contact person	1st name Middle name Last name Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of ophthalmology
Zip code
Address	4-23-35, Hakataekimae, Hakata-ku,Fukuoka, Japan
TEL	092-431-1680
Homepage URL
Email	hayashi-ken@hayashi.or.jp

Sponsor
Institute	Hayashi Eye Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
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Name of secondary funder(s)

IRB Contact (For public release)
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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	林眼科病院（福岡県）/ Hayashi Eye Hospital(Fukuoka)

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date	2016 Year 11 Month 21 Day
Last follow-up date
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Date trial data considered complete
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Other
Other related information

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2018 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032490

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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