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

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04699266
Collaborator
(none)
22
Enrollment
1
Location
1
Arm
13
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Assigned Intervention (POD F GF)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the Multifocal Intraocular Lens (IOL) POD F GF in Cataracteous Eyes
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Binocular Best corrected distance visual acuity (5 m) [Postoperative Day 120-180 (4-6 months)]

    CDVA measured with ETDRS charts placed in 5m distance with best aided corrective glasses according to ISO 11979-7:2014.

  2. Binocular Distance corrected near visual acuity (40 cm) [Postoperative Day 120-180 (4-6 months)]

    DCIVA measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014.

  3. Binocular Distance corrected intermediate visual acuity (80 cm) [Postoperative Day 120-180 (4-6 months)]

    DCIVA measured with ETDRS charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014.

Secondary Outcome Measures

  1. Binocular photopic best corrected distance visual acuity (5 m) [Postoperative Day 120-180]

    DCIVA outcomes at 5m distance

  2. Monocular and binocular photopic uncorrected distance visual acuity (5 m) [Postoperative Day 120-180]

    UDVA outcomes at n 5m distance

  3. Monocular and binocular photopic uncorrected intermediate visual acuity and binocular distance corrected intermediate visual acuity (80 cm) [Postoperative Day 120-180]

    DCIVA outcomes at 80cm distance

  4. Monocular and binocular photopic uncorrected near visual acuity and binocular distance corrected visual acuity (40cm) [Postoperative Day 120-180]

    DCNVA outcomes at 40cm distance

  5. Binocular photopic defocus curves [Postoperative Day 120-180]

    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.

  6. Contrast Sensitivity under photopic light conditions [Postoperative Day 120-180]

    Contrast Sensitivity outcomes under photopic light conditions

  7. Contrast Sensitivity under mesopic light conditions [Postoperative Day 120-180]

    Contrast Sensitivity outcomes under photopic light conditions

  8. Quality of Vison: VFQ-11 Questionnaire [Postoperative Day 120-180]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Miyata Eye HospitalMiyataJapan

Sponsors and Collaborators

  • Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Kazunori Miyata, MD, PhD, Miyata Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier:
NCT04699266
Other Study ID Numbers:
  • PHY2002
First Posted:
Jan 7, 2021
Last Update Posted:
May 3, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beaver-Visitec International, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2021