NCT04699266

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

November 16, 2020

Last Update Submit

July 27, 2023

Conditions

CataractLens OpacitiesPresbyopia

Keywords

Intraocular lensTrifocal

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Binocular photopic best corrected distance visual acuity (5 m)

    Postoperative Day 120-180

  • Monocular and binocular photopic uncorrected distance visual acuity (5 m)

    Postoperative Day 120-180

  • Monocular and binocular photopic uncorrected intermediate visual acuity and binocular distance corrected intermediate visual acuity (80 cm)

    Postoperative Day 120-180

  • Monocular and binocular photopic uncorrected near visual acuity and binocular distance corrected visual acuity (40cm)

    Postoperative Day 120-180

  • Binocular photopic defocus curves

    Postoperative Day 120-180

  • +3 more secondary outcomes

Study Arms (1)

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

Device: Assigned Intervention (POD F GF)

Interventions

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

Experimental: POD F GF IOL Implantation

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts;
  • Able to comprehend and sign a statement of informed consent;
  • Willing and able to complete all required postoperative visits;
  • Calculated lens power within the available range;
  • Planned cataract removal by phacoemulsification;
  • Potential postoperative BCDVA of 0.5 decimal or better in both eyes;
  • Subject with preoperative astigmatism \< 1.0 D
  • Clear intraocular media other than cataract in both eyes;
  • The subject must be able to undergo second eye surgery within 30 days of the first eye surgery.
  • and 5: Cataract extraction is the indication of the clinical study.
  • 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

You may not qualify if:

  • Irregular corneal aberration that affects postoperative visual function as demonstrated by corneal topography;
  • Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
  • 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;
  • Subjects who may be expected to require ocular surgery (other than blepharo-surgery, laser surgery of fundus and YAG capsulotomy) during the study;
  • Previous refractive surgery;
  • Amblyopia;
  • Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia;
  • Diabetic retinopathy;
  • Extremely shallow anterior chamber, not due to swollen cataract;
  • Microphthalmos;
  • Current or previous retinal detachment;
  • Previous corneal transplant;
  • Recurrent severe anterior or posterior segment inflammation of unknown etiology;
  • Rubella or traumatic cataract;
  • Iris neovascularization;
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miyata Eye Hospital

Miyata, Japan

Location

Related Publications (2)

  • 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.

    PMID: 36542257RESULT

  • 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.

    PMID: 41021165DERIVED

Related Links

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Kazunori Miyata, MD, PhD

    Miyata Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

January 7, 2021

Study Start

November 1, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)