Clinical Investigation of the Multifocal IOL POD F GF in Cataracteous Eyes

Clinical Investigation of the Multifocal Intraocular Lens (IOL) POD F GF in Cataracteous Eyes

To evaluate effectiveness and safety of the POD F GF Intraocular Lens (IOL) when implanted to replace the natural lens following cataract removal

Study Overview

• Status: Completed
• Conditions: Cataract; Presbyopia; Lens Opacities
• Intervention / Treatment: Device: Assigned Intervention (POD F GF)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Miyata, Japan
    • Miyata Eye Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts;
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. Planned cataract removal by phacoemulsification;
6. Potential postoperative BCDVA of 0.5 decimal or better in both eyes;
7. Subject with preoperative astigmatism < 1.0 D
8. Clear intraocular media other than cataract in both eyes;
9. The subject must be able to undergo second eye surgery within 30 days of the first eye surgery.

[Justification for the inclusion criteria]

1. and 5: Cataract extraction is the indication of the clinical study.
2. and 3: One of GCP requirements 4: Essential condition for implant of the investigational lens. 6, 7, 8 and 9: Conditions to minimize the potential non-IOL factors which may affect the visual acuity data

Exclusion Criteria:

[Exclusion Criteria Prior to Surgery] The patient who meets any criteria specified in the following 1) through 22).

1. Irregular corneal aberration that affects postoperative visual function as demonstrated by corneal topography;
2. Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
3. Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.5 decimal for BCDVA;
4. Subjects who may be expected to require ocular surgery (other than blepharo-surgery, laser surgery of fundus and YAG capsulotomy) during the study;
5. Previous refractive surgery;
6. Amblyopia;
7. Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia;
8. Diabetic retinopathy;
9. Extremely shallow anterior chamber, not due to swollen cataract;
10. Microphthalmos;
11. Current or previous retinal detachment;
12. Previous corneal transplant;
13. Recurrent severe anterior or posterior segment inflammation of unknown etiology;
14. Rubella or traumatic cataract;
15. Iris neovascularization;
16. Glaucoma or ocular hypertension;
17. Aniridia;
18. Optic nerve atrophy;
19. Planned clear lensectomy (no lens opacity)
20. Pregnancy, lactating or possible pregnant;
21. 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.
22. 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 7).

1. Mechanical or surgical manipulation required to enlarge the pupil;
2. Excessive iris mobility;
3. Significant vitreous loss;
4. Significant anterior chamber hyphema;
5. Uncontrollable intraocular pressure;
6. Zonular or capsular rupture or tear;
7. IOL could not be fixed in the lens capsule;

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: Experimental: POD F GF IOL Implantation; 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	Device: Assigned Intervention (POD F GF); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Helpful Links

• Official study publication of Clinical results

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Intraocular lens; Trifocal
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Presbyopia
• Other Study ID Numbers: PHY2002

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