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

NCT ID: NCT04699266

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-08-30

Brief Summary

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

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.

Conditions

Cataract; Lens Opacities; Presbyopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Assigned Intervention (POD F GF)

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

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

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.

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;

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kazunori Miyata, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Miyata Eye Hospital

Locations

Miyata Eye Hospital

Miyata, , Japan

Countries

Japan

References

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.

Reference Type: RESULT

PMID: 36542257 (View on PubMed)

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. 2025 Sep 29. doi: 10.1007/s10384-025-01274-4. Online ahead of print.

Reference Type: DERIVED

PMID: 41021165 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/36542257/

Official study publication of Clinical results

Other Identifiers

PHY2002

Identifier Type: -

Identifier Source: org_study_id