This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery be implanted with a hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC (model POD T 49P).
This is a Multi-center, single-arm and non-masked study whereby patients undergoing routine cataract surgery will be implanted with a hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC. The device under investigation is a hydrophobic acrylic monofocal toric intraocular lens (IOL) manufactured by the sponsor of this study (BVI Medical). The refractive power of the lens has a spherical and a cylindrical component. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development and showing pre-existing corneal astigmatism. In total approx. 28 patients, 56 eyes will be recruited for this clinical study and undergo implantation of PODEYE TORIC intraocular lens. Subjects participating in the trial will attend a total of maximum 6 study visits over a period of 120-180 days (preoperative, operative, 1-2 days, 7-14 days, 30-60 days, 120-180 days, postoperative visits). Subjects would have the option for unscheduled visits if required medically.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
The investigational lens will be implanted within the capsular bag after removal of the natural crystalline lens following phacoemulsification and alignment the toric axis of investigational lens to the intend axis which was calculated by the Toric calculator software. When enroll the test lenses into both eyes, the lens is implanted first to the eye with more advanced cataract. If both eyes have a similar degree of cataract, perform the surgery first for the right eye. The timing of surgery the investigational lens into the fellow eye will be determined after the investigator and the investigator (hereinafter referred to as the investigator) have confirmed the safety of the previously operated eye.
Chukyo Eye Clinic
Nagoya, Aichi-ken, Japan
Roppongi Shiba Eye Clinic
Minato-Ku, Tokyo, Japan
Miyata Eye Hospital
Miyazaki, Japan
Fujita Eye Clinic
Tokushima, Japan
Uncorrected visual acuity at Visit 4
Uncorrected visual acuity at 5 m will be measured. Convert decimal visual acuity to logMAR value using the following formula. logMAR value = log10 (1/decimal visual acuity)
Time frame: Postoperative Day 120-180
Amount of astigmatism at Visit 4
Manifest cylindrical refraction for Best Collected Distance Visual Acuity will be measured at Visit 4.
Time frame: Postoperative Day 120-180
Best Corrected Distance Visual Acuity
Best Corrected Distance Visual Acuity at 5 m will be measured. The objective is to compare CDVA above defined thresholds of the investigational product.
Time frame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative.
Manifest cylindrical refraction
Manifest cylindrical refraction for Best Collected Distance Visual Acuity will be measured.
Time frame: Pre-Op, 1 month postoperative, 6 months postoperative
IOL rotation
After mydriasis, a photograph of the anterior segment of the test lens is taken using an anterior segment analyzer, and the angle of the toric mark with respect to the horizon is measured as the axial angle. Calculate the number of the eye and the percentage of less than 5 degrees, more than 5 degrees to less than 10 degrees, more than 10 degrees to less than 20 degrees.
Time frame: Pre-Op, 1 month postoperative, 6 months postoperative
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