UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized comparison of intraocular pressure (IOP) and corneal shape between eyes after transconjunctival single-plane scleracorneal incision and clear corneal incision cataract surgery
Title of the study (Brief title)	IOP and corneal shape between eyes with single-plane scleracorneal and corneal incision cataract surgery
Region	Japan

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

Objectives
Narrative objectives1	Recently, surgeons who perform trans- conjunctival single-plane scleracorneal incision cataract surgery are increasing. The purpose of this study was to compare the immediate change in IOP and wound structure, and corneal shape changes between eyes with the single-plane scleracorneal incision and clear corneal incision.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	A) Changes in IOP and wound structure immediately after cataract surrgery 1) Longitudinal changes in IOP using rebound tonometer after cataract surgery preoperatively, at the conclusion of surgery; and at 15, 30, 60, and 120 minutes, and 24 hours postoperatively. 2) Seidel test at 30 minutes postoperatively 3) Wound structure at 30 minutes after surgery using the anterior segment-optical coherence tomography (AS-OCT) B) Changes in corneal astigmatism and shape preoperatively and at 2, 14, 30, and 60 days postoperatively 4) Corneal astigmatism and surgically induced astigmatism determined using keratometer 5) Corneal shape change determined using corneal topography 5-1) Averaged difference map 5-2) Irregular corneal astigmatism determined by Fourier analysis
Key secondary outcomes	6) Corneal endothelial cell counts and central corneal thickness 7) Visual acuity 8) Refractive status (spherical power, refractive cylinder, manifest spherical equivalent power)

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	Phacoemulsification surgery using transconjuctival single-plane sclerocorneal incision with 2.4 mm in length in unilateral eyes of 64 enrolled patients
Interventions/Control_2	Phacoemulsification surgery using clear corneal incision with 2.4 mm in length in contralateral eyes of 64 enrolled patients
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	All consecutive patients who were scheduled for bilateral cataract surgery at the Hayashi Eye Hospital from May 17, 2014. Bilateral eyes of 64 patients scheduled for cataract surgery were randomized to 1 of 2 groups: A) 32 patients who were to undergo a 2.4-mm single-plane sclerocorneal incision in the right eye and 2.4-mm clear corneal incision in the left eye, or B) 32 patients who were to undergo a 2.4-mm single-plane sclerocorneal incision in the left eye and 2.4-mm clear corneal incision in the right eye.
Key exclusion criteria	Exclusion criteria were eyes with any pathology of the cornea, vitreous body, macula, or optic nerve; eyes with glaucoma or ocular hypertension; eyes with pseudoexfoliation syndrome; eyes scheduled for planned extracapsular cataract extraction; a history of previous ocular surgery or inflammation; patients with diabetes; patient refusal; and any anticipated difficulties with examination or follow up.
Target sample size	64

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）

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 06 Day
Anticipated trial start date	2013 Year 12 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2015 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	2014 Year 05 Month 08 Day
Last modified on	2016 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016214