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

NCT05255029 | Completed

• 1 other identifier: PHY2107
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

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).

Conditions

Cataract; Lens Opacities; Astigmatism

Keywords

Intraocular Lens; Monofocal; Toric Lens

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Postoperative Day 120-180

Secondary Outcomes (3)

• Best Corrected Distance Visual Acuity

  Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative.

• Manifest cylindrical refraction

  Pre-Op, 1 month postoperative, 6 months postoperative

• IOL rotation

  Pre-Op, 1 month postoperative, 6 months postoperative

Other Outcomes (9)

• Intraocular pressure (IOP) measurement

  Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative

• Slitlamp examination - Corneal Status

  Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative

• Fundus examination with dilated pupil

  Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative

Study Arms (1)

PODEYE Toric Intra Ocular Lens Implantation experimental

EXPERIMENTAL

Implantation of PODEYE toric intraocular lenses.

Device: POD T 49P implantation experimental

Interventions

POD T 49P implantation experimental DEVICE

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.

PODEYE Toric Intra Ocular Lens Implantation experimental

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and 6: Cataract extraction is the indication of the clinical study. 2 and 3: One of GCP requirements 4 and 5: Essential condition for implant of the investigational lens. 7 and 8: Conditions to minimize the potential non-IOL factors which may affect the visual acuity data

You may not qualify if:

• Subjects with diseases that affect postoperative visual acuity in the cornea (keratitis, corneal degeneration, corneal dilatation, corneal edema);
• Previous corneal transplant;
• Previous refractive surgery;
• Irregular corneal aberration
• Subjects with diseases that affect postoperative visual acuity in the retina (retinal degeneration, diabetic retinopathy, retinal detachment);
• Poor mydriasis;
• Glaucoma or ocular hypertension;
• Optic nerve atrophy;
• Extremely shallow anterior chamber;
• Aniridia;
• Iris neovascularization;
• Microphthalmos;
• Amblyopia;
• Rubella, atopic or traumatic cataract;
• Recurrent severe anterior or posterior segment inflammation of unknown etiology;

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (4)

Chukyo Eye Clinic

Nagoya, Aichi-ken, Japan

Location

Roppongi Shiba Eye Clinic

Minato-Ku, Tokyo, Japan

Location

Miyata Eye Hospital

Miyazaki, Japan

Location

Fujita Eye Clinic

Tokushima, Japan

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Study Officials

• MIYATA Kazunori, MD

  Miyata Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1\) Summary of investigational lens Model: POD T 49P General name: PODEYE Toric Construction Single-piece construction lens consisting of the optic and the haptic made of the same material, optic diameter: 6.0 mm, overall length: 11.4 mm (Fig.1). Cylinder power is added on the posterior optics.

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: February 24, 2022
• Study Start: December 24, 2021
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)