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To evaluate effectiveness and safety of the POD F GF Intraocular Lens (IOL) when implanted to replace the natural lens following cataract removal
Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be bilaterally implanted. Considering the safety of the study subjects, the time of implant to the remaining eye (2nd eye) will be decided based on the results of the 1st implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: POD F GF IOL Implantation | Experimental | Experimental: POD F GF IOL Implantation experimental Multi-center, single-arm, non-masked study Mono- or bilateral implantation of trifocal intraocular lenses POD F GF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assigned Intervention (POD F GF) | Device | The investigational lens (POD F GF )will be implanted to both eyes in subjects with bilateral cataract. Registration of patients and the implantation of the investigational lens (POD F GF) will be conducted in consideration of securing 44 eyes in 22 subjects as the analysis subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Best corrected distance visual acuity (5 m) | CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014. | Postoperative Day 120-180 (4-6 months) |
| Binocular Distance corrected near visual acuity (40 cm) | DCIVA measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. | Postoperative Day 120-180 (4-6 months) |
| Binocular Distance corrected intermediate visual acuity (80 cm) | DCIVA measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. | Postoperative Day 120-180 (4-6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic best corrected distance visual acuity (5 m) | DCIVA outcomes at 5m distance | Postoperative Day 120-180 |
| Monocular and binocular photopic uncorrected distance visual acuity (5 m) |
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Inclusion Criteria:
[Justification for the inclusion criteria]
Exclusion Criteria:
[Exclusion Criteria Prior to Surgery] The patient who meets any criteria specified in the following 1) through 22).
[Exclusion Criteria During Surgery] The patient who meets any criteria specified in the following 1) through 7).
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| Name | Affiliation | Role |
|---|---|---|
| Kazunori Miyata, MD, PhD | Miyata Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miyata Eye Hospital | Miyata | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36542257 | Result | Mori Y, Miyata K, Suzuki H, Noguchi S, Ichikawa K, Maeda N. Clinical Performance of a Hydrophobic Acrylic Diffractive Trifocal Intraocular Lens in a Japanese Population. Ophthalmol Ther. 2023 Apr;12(2):867-878. doi: 10.1007/s40123-022-00634-4. Epub 2022 Dec 21. | |
| 41021165 | Derived | Mori Y, Miyata K, Kojima T, Ichikawa K, Fujita Y, Shiba T, Bissen-Miyajima H. Clinical performance of a hydrophobic acrylic toric intraocular lens with a double C-loop haptics in Japanese patients. Jpn J Ophthalmol. 2026 Mar;70(2):278-285. doi: 10.1007/s10384-025-01274-4. Epub 2025 Sep 29. |
| Label | URL |
|---|---|
| Official study publication of Clinical results | View source |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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|
UDVA outcomes at n 5m distance
| Postoperative Day 120-180 |
| Monocular and binocular photopic uncorrected intermediate visual acuity and binocular distance corrected intermediate visual acuity (80 cm) | DCIVA outcomes at 80cm distance | Postoperative Day 120-180 |
| Monocular and binocular photopic uncorrected near visual acuity and binocular distance corrected visual acuity (40cm) | DCNVA outcomes at 40cm distance | Postoperative Day 120-180 |
| Binocular photopic defocus curves | To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. | Postoperative Day 120-180 |
| Contrast Sensitivity under photopic light conditions | Contrast Sensitivity outcomes under photopic light conditions | Postoperative Day 120-180 |
| Contrast Sensitivity under mesopic light conditions | Contrast Sensitivity outcomes under photopic light conditions | Postoperative Day 120-180 |
| Quality of Vison: VFQ-11 Questionnaire | Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified Visual Functioning Questionnaire - 25 (VFQ-25) will be used. The maximum score for each questionaire is 100. | Postoperative Day 120-180 |