UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Surgically Induced Astigmatic Change and Shape Changes of Total, Anterior, and Posterior Corneas After Long- versus Short-Length Clear Corneal Incision Cataract Surgery: A Randomized Clinical Study
Title of the study (Brief title)	Surgically Induced Astigmatism and Shape Changes of Total, Anterior, and Posterior Corneas After Long versus Short Clear Corneal Incision Cataract Surgery
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, anterior, or posterior cornea between eyes with long-length clear corneal incisions (CCIs) and eyes with short-length CCIs in cataract surgery.
Basic objectives2	Others
Basic objectives -Others	Eyes are to randomly assigned to undergo long-length (not less than 1.75 mm) or short-length (<1.75mm) CCI of 2.4 mm in width SIA of total, anterior, and posterior corneas is determined using power vector analysis, and corneal shape changes are assessed using a videokeratography preoperatively, and postoperatively at 2 days, and 2, 4, and 8 weeks.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
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 total, anterior, and posterior corneas (simulated K value of a videokeratography system; Tomey TMS-5) 2) Surgically induced astigmatic change of total, anterior, and posterior corneas (power vector analysis) 3) Shape changes in of total, anterior, and posterior corneas (average of difference map of TMS-5)
Key secondary outcomes	4) Incision length of clear corneal incisions 5) Irregular astigmatism components (asymmetry and higher-order irregularity components) 6) Ocular, corneal, and internal optic higher order aberrations (HOAs) 7) Corrected distance visual acuity and manifest spherical equivalent value

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	Bilateral (240) eyes of 120 patients are randomly assigned to undergo long-length (no more than 1.75mm)
Interventions/Control_2	That reverse eyes 120 patients are randomly assigned to undergo short-length (<1.75mm) clear corneal incision (CCI)of 2.4 mm in width.
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 who are scheduled for bilateral phacoemulsification surgery with an acrylic intraocular lens (IOL) implantation at the Hayashi Eye Hospital between November 1, 2015 and November 11, 2016.
Key exclusion criteria	Exclusion criteria are eyes with pathologies except for cataract; eyes with pseudoexfoliation syndrome; eyes that were to undergo planned extracapsular or intracapsular cataract extraction; eyes with a possible zonular dehiscence; a history of ocular surgery or inflammation; patients with diabetes mellitus; patients who refused the inclusion in the study; and difficulties with examination or follow-up. Patients who were enrolled in other studies were excluded.
Target sample size	120

Research contact person
Name of lead principal investigator	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of ophthalmology
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	Ken Hayashi
Organization	Hayashi Eye Hospital
Division name	Department of ophthalmology
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
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	林眼科病院（福岡県） Hayashi Eye Hospital(Fukuoka)

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 28 Day
Anticipated trial start date	2015 Year 10 Month 30 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	2016 Year 12 Month 21 Day
Last modified on	2017 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029150