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A Study of Visual Performance after Implantation of the Acrylic Toric IO

Not Applicable
Conditions
senile (age-related) cataract
Registration Number
JPRN-UMIN000008284
Lead Sponsor
Preventive Medicine Foundation (Yoboigaku Jigyo Chuokai)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

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,

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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