Clinical trial NCT05255029: Clinical Investigation of a Monofocal Toric Intra Ocular Lens (IOL) in Cataractous Eyes
Official title: Clinical Investigation of the Monofocal Toric IOL POD T 49P in Cataractous Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Astigmatism
Keywords: Intraocular Lens
Monofocal
Toric Lens
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-24
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uncorrected visual acuity at Visit 4
timeFrame: Postoperative Day 120-180
measure: Amount of astigmatism at Visit 4
timeFrame: Postoperative Day 120-180
Secondary outcomes:
measure: Best Corrected Distance Visual Acuity
timeFrame: Pre-Op, 1 week postoperative, 1 month postoperative, 6 months postoperative.
measure: Manifest cylindrical refraction
timeFrame: Pre-Op, 1 month postoperative, 6 months postoperative
measure: IOL rotation
timeFrame: Pre-Op, 1 month postoperative, 6 months postoperative
Other outcomes:
measure: Intraocular pressure (IOP) measurement
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
measure: Slitlamp examination - Corneal Status
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
measure: Fundus examination with dilated pupil
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
measure: Slitlamp examination
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
measure: Slitlamp examination - Retinal detachment
timeFrame: Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Slitlamp examination - IOL decentration
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Slitlamp examination - IOL tilt
timeFrame: 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
measure: Adverse events
timeFrame: Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
measure: Device deficiencies
timeFrame: Pre-Op, during surgery, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative
Locations:
city: Nagoya
country: Japan
facility: Chukyo Eye Clinic
state: Aichi
city: Minato-Ku
country: Japan
facility: Roppongi Shiba Eye Clinic
state: Tokyo
city: Miyazaki
country: Japan
facility: Miyata Eye Hospital
city: Tokushima
country: Japan
facility: Fujita Eye Clinic
Study officials:
affiliation: Miyata Eye Hospital
name: MIYATA Kazunori, MD
role: PRINCIPAL_INVESTIGATOR
References: