senile (age-related) cataract
Conditions
Interventions
acrylic toric IOLs, Models SN6AT3
acrylic toric IOLs, Models SN6AT4
acrylic toric IOLs, Models SN6AT5
tinted acrylic aspheric IOL, Model SN60WF
Sponsors
Preventive Medicine Foundation (Yoboigaku Jigyo Chuokai)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Outcome results
None listed