UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized double-masked comparative study of intraocular pressure (IOP) and wound architectures immediately after cataract surgery between eyes with long-length clear corneal incision (CCI) and short-lengh clear corneal incision.
Title of the study (Brief title)	Intraocular pressure (IOP) and wound architectures in eyes immediately after long and 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 the present study was to compare the IOP and wound architectures immediately after phacoemulsificaton surgery between eyes that underwent long-length CCI (more than 1.75mm) and eyes that underwent short-length CCI (less than 1.75 mm.)
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Longitudinal changes in intraocular pressure (IOP) using rebound tonometer before surgery, at the end of surgery (adjusted in a range between 15 and 25 mmHg); and at 30, 60, 120, 180 minutes, and 24 hours after surgery 2) Wound architectural features and wound length at 60 minutes after surgery using the anterior segment-optical coherence tomography (AS-OCT)
Key secondary outcomes	3) Wound leakage at 60 minutes after surgery examined using the Seidel test 4) Flare intensity at 60 minutes after surgery determined using the flare meter

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
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	64 eyes of 64 patients are scheduled to undergo long-length temporal CCI (more than 1.75 mm).
Interventions/Control_2	64 eyes of 64 patients are scheduled to undergo short-length temporal CCI (less than 1.75 mm).
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	This study was an exploratory study to compare the IOP and wound architectures between eyes with long CCI and eyes with short CCI, conducted between January and December, 2017 at the Hayashi Eye Hospital. A clinical research coordinator screened all consecutive patients scheduled for admitting the Hayashi Eye Hospital to undergo bilateral phacoemulsification and implantation of a single-piece acrylic intraocular lens (IOL).
Key exclusion criteria	eyes with any pathology of the cornea, macula, and optic nerve; eyes with lens nucleus harder than grade 4 according to the Lens Opacities Classification System III;14 eyes with a possible zonular dehiscence, a history of ocular inflammation or surgery; eyes with poor mydriasis smaller than 4.5 mm; patient refusal; and any anticipated difficulties with examination
Target sample size	128

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	None
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（福岡市）Hayashi Eye Hospital(Fukuoka)

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 25 Day
Anticipated trial start date	2017 Year 08 Month 04 Day
Last follow-up date	2017 Year 12 Month 19 Day
Date of closure to data entry	2017 Year 12 Month 19 Day
Date trial data considered complete	2017 Year 12 Month 19 Day
Date analysis concluded	2017 Year 12 Month 29 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Not analyzed
Other related information

Management information
Registered date	2017 Year 12 Month 22 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=R000034834