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CataractNCT04699266

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

A study testing Assigned Intervention (POD F GF) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 years and older
Conditions the study is for
Cataract, Lens Opacities, Presbyopia
What is being tested?
Assigned Intervention (POD F GF)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteJapan
Study dates
1 Nov 2020to 30 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.
  • [Justification for the inclusion criteria]
  • 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

Who cannot join

  • [Exclusion Criteria Prior to Surgery] The patient who meets any criteria specified in the following 1) through 22).
  • 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;
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  • 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;
  • Glaucoma or ocular hypertension;
  • Aniridia;
  • Optic nerve atrophy;
  • Planned clear lensectomy (no lens opacity)
  • Pregnancy, lactating or possible pregnant;
  • 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.
  • 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).
  • Mechanical or surgical manipulation required to enlarge the pupil;
  • Excessive iris mobility;
  • Significant vitreous loss;
  • Significant anterior chamber hyphema;
  • Uncontrollable intraocular pressure;
  • Zonular or capsular rupture or tear;
  • IOL could not be fixed in the lens capsule;

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Miyata Eye Hospital

    Miyata

Other trials in Japan

About this study

Official title: 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

Read the 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.

Being tested
Assigned Intervention (POD F GF)
Keywords
Intraocular lens, Trifocal
Medical subject headings
Cataract, Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT04699266
Study groupRoleWhat they receive
Experimental: POD F GF IOL ImplantationExperimentalExperimental: POD F GF IOL Implantation experimental Multi-center, single-arm, non-masked study Mono- or bilateral implantation of trifocal intraocular lenses POD F GF
Receives: Device: Assigned Intervention (POD F GF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Postoperative Day 120-180 (4-6 months)

  2. 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.

    Measured: Postoperative Day 120-180 (4-6 months)

  3. 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.

    Measured: Postoperative Day 120-180 (4-6 months)

Secondary outcomes (8)

  1. Binocular photopic best corrected distance visual acuity (5 m)

    DCIVA outcomes at 5m distance

    Measured: Postoperative Day 120-180

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

    UDVA outcomes at n 5m distance

    Measured: Postoperative Day 120-180

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

    DCIVA outcomes at 80cm distance

    Measured: Postoperative Day 120-180

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

    DCNVA outcomes at 40cm distance

    Measured: Postoperative Day 120-180

  5. 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.

    Measured: Postoperative Day 120-180

  6. Contrast Sensitivity under photopic light conditions

    Contrast Sensitivity outcomes under photopic light conditions

    Measured: Postoperative Day 120-180

  7. Contrast Sensitivity under mesopic light conditions

    Contrast Sensitivity outcomes under photopic light conditions

    Measured: Postoperative Day 120-180

  8. 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.

    Measured: Postoperative Day 120-180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2021
  2. Study start1 Nov 2020
  3. Primary completion30 Aug 2021
  4. Study completion30 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04699266
Sponsor's protocol ID
PHY2002
Status last verified
Jul 2023
First submitted
16 Nov 2020
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 36542257

  • 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.

    PubMed 41021165

Questions about this trial

What is this clinical trial studying?

A study testing Assigned Intervention (POD F GF) in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binocular Best corrected distance visual acuity (5 m) (time frame: Postoperative Day 120-180 (4-6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04699266, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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