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

NCT ID: NCT05255029

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-24
• Study Completion Date: 2023-02-28

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.

Conditions

Cataract; Lens Opacities; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PODEYE Toric Intra Ocular Lens Implantation experimental

Implantation of PODEYE toric intraocular lenses.

Group Type: EXPERIMENTAL

POD T 49P implantation experimental

Intervention Type: 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.

Interventions

POD T 49P implantation experimental

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1 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

Exclusion Criteria

1. Subjects with diseases that affect postoperative visual acuity in the cornea (keratitis, corneal degeneration, corneal dilatation, corneal edema);

2. Previous corneal transplant;

3. Previous refractive surgery;

4. Irregular corneal aberration

5. Subjects with diseases that affect postoperative visual acuity in the retina (retinal degeneration, diabetic retinopathy, retinal detachment);

6. Poor mydriasis;

7. Glaucoma or ocular hypertension;

8. Optic nerve atrophy;

9. Extremely shallow anterior chamber;

10. Aniridia;

11. Iris neovascularization;

12. Microphthalmos;

13. Amblyopia;

14. Rubella, atopic or traumatic cataract;

15. Recurrent severe anterior or posterior segment inflammation of unknown etiology;

16. Subjects who may be expected to require ocular surgery during this study;

17. The axial length cannot be measured with an optical biometry;

18. Pregnancy, lactating or possible pregnant;

19. Participation in any clinical study (drug or device) within 3 months prior to participating this study, planned participation another clinical study during this study, or currently participating in another study.

20. Disqualified by the investigator or the sub-investigator because of physical or ophthalmic diseases

1. Mechanical or surgical manipulation required to enlarge the pupil;

2. Excessive iris mobility;

3. Uncontrollable intraocular pressure;

4. Continuous Curvilinear Capsulorrhexis (CCC) with incomplete circle or tear;

5. Zonular or capsular rupture or tear;

6. Significant anterior chamber hyphema;

7. Significant vitreous loss;

8. IOL could not be fixed in the lens capsule;

In the event of zonular damage, capsulorhexis tear, or decentered capsulorhexis during surgery, the surgeon should decide whether the stability of the Intra Ocular Lens (IOL) would be compromised by the complication. If the IOL stability would be compromised, the investigational IOL should not be implanted, the subject should be discontinued from the study, and the surgeon should make arrangements to implant an alternative non-investigational IOL.

1, 2, 4, 5 and 8: Factors potentially affecting effectiveness evaluability 3, 6 and 7: Criteria to secure safety of study subjects

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MIYATA Kazunori, MD

Role: PRINCIPAL_INVESTIGATOR

Miyata Eye Hospital

Locations

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

Countries

Japan

Other Identifiers

PHY2107

Identifier Type: -

Identifier Source: org_study_id