Clinical trial NCT04699266: Clinical Investigation of the Multifocal IOL POD F GF in Cataracteous Eyes
Official title: Clinical Investigation of the Multifocal Intraocular Lens (IOL) POD F GF in Cataracteous Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular lens
Trifocal
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-07
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

\[Justification for the inclusion criteria\]

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;

Primary outcomes:
measure: Binocular Best corrected distance visual acuity (5 m)
timeFrame: Postoperative Day 120-180 (4-6 months)
measure: Binocular Distance corrected near visual acuity (40 cm)
timeFrame: Postoperative Day 120-180 (4-6 months)
measure: Binocular Distance corrected intermediate visual acuity (80 cm)
timeFrame: Postoperative Day 120-180 (4-6 months)
Secondary outcomes:
measure: Binocular photopic best corrected distance visual acuity (5 m)
timeFrame: Postoperative Day 120-180
measure: Monocular and binocular photopic uncorrected distance visual acuity (5 m)
timeFrame: Postoperative Day 120-180
measure: Monocular and binocular photopic uncorrected intermediate visual acuity and binocular distance corrected intermediate visual acuity (80 cm)
timeFrame: Postoperative Day 120-180
measure: Monocular and binocular photopic uncorrected near visual acuity and binocular distance corrected visual acuity (40cm)
timeFrame: Postoperative Day 120-180
measure: Binocular photopic defocus curves
timeFrame: Postoperative Day 120-180
measure: Contrast Sensitivity under photopic light conditions
timeFrame: Postoperative Day 120-180
measure: Contrast Sensitivity under mesopic light conditions
timeFrame: Postoperative Day 120-180
measure: Quality of Vison: VFQ-11 Questionnaire
timeFrame: Postoperative Day 120-180
Other outcomes:
Locations:
city: Miyata
country: Japan
facility: Miyata Eye Hospital
Study officials:
affiliation: Miyata Eye Hospital
name: Kazunori Miyata, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.