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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PODEYE Toric Intra Ocular Lens Implantation experimental | Experimental | Implantation of PODEYE toric intraocular lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
The patient who meets all criteria specified in the following 1) through 8)
[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).
[Exclusion Criteria During Surgery] The patient who meets any criteria specified in the following 1) through 8).
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
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| Name | Affiliation | Role |
|---|---|---|
| MIYATA Kazunori, MD | Miyata Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chukyo Eye Clinic | Nagoya | Aichi-ken | Japan | |||
| Roppongi Shiba Eye Clinic |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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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.
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|
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 |
| 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:
| Pre-Op, 1 day postoperative, 1 week postoperative, 1 month postoperative, 6 months postoperative |
| 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 |
| 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 |
| Minato-Ku |
| Tokyo |
| Japan |
| Miyata Eye Hospital | Miyazaki | Japan |
| Fujita Eye Clinic | Tokushima | Japan |