Clinical Investigation of a Monofocal Toric Intra Ocular Lens (IOL) in Cataractous Eyes (PHY2107)

Clinical Investigation of the Monofocal Toric IOL POD T 49P in Cataractous Eyes

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).

Study Overview

• Status: Completed
• Conditions: Cataract; Astigmatism; Lens Opacities
• Intervention / Treatment: Device: POD T 49P implantation experimental

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Miyazaki, Japan
    • Miyata Eye Hospital
  • Tokushima, Japan
    • Fujita Eye Clinic
  • Aichi
    • Nagoya, Aichi, Japan
      • Chukyo Eye Clinic
  • Tokyo
    • Minato-Ku, Tokyo, Japan
      • Roppongi Shiba Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

The patient who meets all criteria specified in the following 1) through 8)

1. Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with cataract;
2. Able to comprehend and sign a statement of informed consent;
3. Willing and able to complete all required postoperative visits;
4. Calculated lens power within the available range;
5. Subject with corneal astigmatism or subjects who is judged by the investigator or investigator to correct of astigmatism as a result of considering the predicted surgical induced astigmatism.
6. Planned cataract removal by phacoemulsification;
7. Target postoperative refraction is emmetropia and potential postoperative Collected Distance Visual Acuity (CDVA) of 0.5 decimal or better in both eyes;
8. Clear intraocular media other than cataract in both eyes;

[Justification for the 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

(3) Exclusion Criteria [Exclusion Criteria Prior to Surgery] The patient who meets any criteria specified in the following 1) through 20).

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

[Exclusion Criteria During Surgery] The patient who meets any criteria specified in the following 1) through 8).

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.

[Justifications for the exclusion criteria] {Exclusion Criteria Prior to Surgery} 1, 2, 3, 4, 5, 7, 8, 14, 15, 16 and 20: Factors potentially affecting effectiveness evaluability and criteria to secure safety of study subjects 6, 13 and17: Factors potentially affecting effectiveness evaluability 9, 10, 11, 12, 18 and 19: Criteria to secure safety of study subjects

{Exclusion Criteria During Surgery}

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PODEYE Toric Intra Ocular Lens Implantation experimental; Implantation of PODEYE toric intraocular lenses.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Pre-Op, 1 month postoperative, 6 months postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slitlamp examination - Retinal detachment	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Retinal detachment	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Slitlamp examination - IOL decentration	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL decentration	1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Intraocular pressure (IOP) measurement	The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
Slitlamp examination - Corneal Status	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Corneal Status	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
Fundus examination with dilated pupil	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
Slitlamp examination	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: Signs of inflammation; Anterior chamber cells,; Anterior chamber flare,; Cystoid macular oedema,; Hypopyon, and; Endophthalmitis	Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
Slitlamp examination - IOL tilt	The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • IOL tilt	1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
Adverse events	Record the presence or absence of AE after Informed Consent.	Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
Device deficiencies	Record the presence or absence of device deficiencies after Informed Consent.	Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Principal Investigator: MIYATA Kazunori, MD, Miyata Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2021
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: February 15, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Intraocular Lens; Monofocal; Toric Lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: PHY2107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No