Clinical Investigation of a Monofocal Toric Intra Ocular Lens (IOL) in Cataractous Eyes

Not Applicable

Completed

• Conditions: Lens Opacities; Astigmatism; Cataract
• Interventions: Device: POD T 49P implantation experimental

• Registration Number: NCT05255029
• Lead Sponsor: Beaver-Visitec International, Inc.

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2021-11-26
• Study Start: 2021-12-24
• Study First Submitted QC: 2022-02-15
• Study First Posted: 2022-02-24
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PODEYE Toric Intra Ocular Lens Implantation experimental	POD T 49P implantation experimental	Implantation of PODEYE toric intraocular lenses.

Primary Outcome Measures

Name	Time	Method
Uncorrected visual acuity at Visit 4	Postoperative Day 120-180	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)
Amount of astigmatism at Visit 4	Postoperative Day 120-180	Manifest cylindrical refraction for Best Collected Distance Visual Acuity will be measured at Visit 4.

Secondary Outcome Measures

Name	Time	Method
IOL rotation	Pre-Op, 1 month postoperative, 6 months postoperative	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.
Manifest cylindrical refraction	Pre-Op, 1 month postoperative, 6 months postoperative	Manifest cylindrical refraction for Best Collected Distance Visual Acuity will be measured.
Best Corrected Distance Visual Acuity	Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative.	Best Corrected Distance Visual Acuity at 5 m will be measured. The objective is to compare CDVA above defined thresholds of the investigational product.

Trial Locations

Locations (4)

Fujita Eye Clinic; 🇯🇵 Tokushima, Japan

Roppongi Shiba Eye Clinic; 🇯🇵 Minato-Ku, Tokyo, Japan

Chukyo Eye Clinic; 🇯🇵 Nagoya, Aichi, Japan

Miyata Eye Hospital; 🇯🇵 Miyazaki, Japan