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

Cataract Clinical Trial

— PHY2107  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05255029
• Other study ID #: PHY2107
• Status: Completed
• Phase: N/A
• Start date: December 24, 2021
• Est. completion date: February 28, 2023

Study information

• Verified date: July 2023
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract
• Lens Opacities

Intervention

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.

Locations

Country	Name	City	State
Japan	Roppongi Shiba Eye Clinic	Minato-Ku	Tokyo
Japan	Miyata Eye Hospital	Miyazaki
Japan	Chukyo Eye Clinic	Nagoya	Aichi
Japan	Fujita Eye Clinic	Tokushima

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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.
Secondary	Manifest cylindrical refraction	Manifest cylindrical refraction for Best Collected Distance Visual Acuity will be measured.	Pre-Op, 1 month postoperative, 6 months postoperative
Secondary	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