UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study of Visual Performance after Implantation of the Acrylic Toric IOL
Title of the study (Brief title)	A Study of Visual Performance after Implantation of the Acrylic Toric IOL
Region	Japan

Condition
Condition	senile (age-related) cataract
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study is to be performed for the assessment of the postoperative visual performance and intracapsular stability of acrylic toric IOLs, Models SN6AT3, SN6AT4, and SN6AT5 (tinted aspheric) as well as the comparative assessment of the astigmatism attenuating effects in comparison with the control tinted acrylic aspheric IOL, Model SN60WF (non-toric). And, to confirm the postoperative visual performance which put SN6AT3~5 into the patients with astigmatism is the same as the postoperative visual performance which put SN60WF into the patients without astigmatism.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety Calculate the number of patients (eyes) with AEs and the incidence rate. Also assess ophthalmic findings, posterior capsulectomy, IOL findings, IOL deflection, intraocular pressure, presence or absence of secondary surgery, corneal endothelial cell count, and flare as the safety endpoints. Efficacy Calculate the descriptive statistics of the mean of each data at the prescribed examination/observation time according to the stratification by the IOL and the marking method as well as the number of patients (eyes) and the incidence rate according to the following classifications. Primary endpoints Distance visual acuity, subjective cylinder power, IOL decentration/ rotation (angle of toric mark)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	acrylic toric IOLs, Models SN6AT3
Interventions/Control_2	acrylic toric IOLs, Models SN6AT4
Interventions/Control_3	acrylic toric IOLs, Models SN6AT5
Interventions/Control_4	tinted acrylic aspheric IOL, Model SN60WF
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	1) Patients who intend to undergo cataract surgery by ultrasonic phacoemulsification (with aspiration). 2) Patients whose calculated lens frequency is within the lens frequency of the investigational eye. 3) Patients expected to achieve postoperative distant corrected vision of not less than 0.7. 4) Patients expected to achieve normal vision. 5) Toric IOL treatment group: Patients whose preoperative corneal astigmatism of the surgical eye is not more than 3.0 D and who are assessed treatable with SN6AT3, SN6AT4, and SN6AT5 based on the data obtained from the calculation using the toric calculator. Control IOL treatment group: Patient whose preoperative corneal astigmatism of the surgical eye is not more than 1.5D. 6) Patients who have no opacification in the optic media other than the lens (cataract). 7) Patients who understand the informed consent document and are able to give their consent. 8) Patients anticipated to undergo postoperative follow- up as instructed by the investigator.
Key exclusion criteria	Preoperative 1)Patients with poorly controlled glaucoma. 2)Patients with progressive diabetic retinopathy. 3)Patients with active uveritis. 4)Patients with angiogenesis of iris. 5)Patients with retinal detachment. 6)Patients with abnormal aberration including corneal astigmatism. 7)Patients with past history of corneal refractive surgery. 8)Patients with corneal degeneration such as Fuchs's corneal degeneration. 9)Patients with past history of corneal transplantation. 10)Patients not adequately assessable by funduscopy due to severe preoperative lens opacification. 11)Patients having any disease or using any drug potentially affecting visual acuity. 12)Patients undergoing secondary placement. 13)Pregnant or potentially pregnant or lactating patients. 14)Patients who have participated in any other clinical study (drug or medical device) within 3 months before participation in this clinical study or who intend to participate in any other clinical study during participation in this clinical study. 15)Patients with amydriasis which prevents the investigator from reading the toric marker on the IOL surface even using a mydriatic. 16)Other patients disqualified by the investigator. Intraoperative 1)Patients who intend to undergo any other ophthalmic surgery (e.g. LASIK, corneal incision for astigmatism correction). 2)Patients who need mechanical or surgical procedures for pupillary dilatation. 3)Patients with massive vitreous loss. 4)Patients with massive anterior chamber bleeding. 5)Patients who have uncontrollable variation of intraocular pressure. 6)Patients who have a rupture of Zinn's zonule. 7)Patients with pseudo-exfoliation syndrome. 8)Patients who can not undergo intracapsular fixation because of the location of IOL haptic. Note: Patients considered to have dislocation of the IOL when the investigator assesses the stability of the IOL for Zinn's zonule,
Target sample size	200

Research contact person
Name of lead principal investigator	Kazunori Miyata
Organization	Medical corporation (meiwakai)
Division name	Miyata Ophthalmic Hospital
Address	6-3,kurahara-cho,miyakonojo-city,miyazakiken
TEL	-
Email	-@-

Public contact
Name of contact person
Organization	QOL RD Co.,Ltd.
Division name	EBM Division
Address	http://www.qol-rd.co.jp
TEL	03-5777-1001
Homepage URL
Email	-@-

Sponsor
Institute	Preventive Medicine Foundation (Yoboigaku Jigyo Chuokai)
Institute
Department

Funding Source
Organization	Preventive Medicine Foundation (Yoboigaku Jigyo Chuokai)
Organization
Division
Category of Funding Organization	Non profit foundation
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

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 08 Day
Anticipated trial start date	2011 Year 10 Month 01 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	2012 Year 06 Month 28 Day
Last modified on	2017 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009691