NCT03974451

Brief Summary

This is a prospective randomised open-label study with the aim to compare the visual performance of the trifocal FineVision® IOL versus the extended range of vision Symfony® IOL after phaco-emulsification cataract surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2019

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

April 11, 2019

Last Update Submit

July 19, 2022

Conditions

CataractLens OpacitiesPresbyopia

Keywords

Intraocular Lenstrifocalextended range of visiondiffractive achromatic technology

Outcome Measures

Primary Outcomes (1)

  • Corrected Distance Visual Acuity at 6m (CDVA) - monocular

    CDVA is measured with ETDRS charts placed in 6m distance with best aided corrective glasses according to International Standards Organization (ISO) 11979-7:2014. This assessment is done monocularly.

    3 months postoperative

Secondary Outcomes (9)

  • Uncorrected Distance Visual Acuity at 6m (UDVA) - monocular

    3 months postoperative

  • Uncorrected Intermediate Visual Acuity at 65cm (UIVA) - monocular

    3 months postoperative

  • Distance Corrected Intermediate Visual Acuity at 65cm (DCIVA) - monocular

    3 months postoperative

  • Uncorrected Near Visual Acuity at 35cm (UNVA)

    3 months postoperative

  • Distance Corrected Near Visual Acuity at 35cm (DCNVA) - monocular

    3 months postoperative

  • +4 more secondary outcomes

Study Arms (2)

IOL implantation experimental

EXPERIMENTAL

Implantation of the PhysIOL FineVision POD F® IOL

Device: IOL implantation experimental

IOL implantation active comparator

ACTIVE COMPARATOR

Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL.

Device: IOL implantation active comparator

Interventions

IOL implantation experimentalDEVICE

Implantation of of PhysIOL trifocal FineVision® POD F IOL

IOL implantation experimental
IOL implantation active comparatorDEVICE

Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL

IOL implantation active comparator

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cataract patients requesting independence from spectacles
  • Potential visual acuity of 0.0 logMar

You may not qualify if:

  • Unrealistic expectations (sharp clear vision is the main concern of the patient)
  • Ocular pathology besides cataract (glaucoma, macular degeneration, retinopathies, corneal opacities, corneal guttata.. etc.)
  • Previous refractive surgery
  • Expected pathology after surgery (p.e. uveitis, diabetic retinopathy, PEX)
  • Preoperative corneal astigmatism of \> 1.0 D
  • Any intraocular or postoperative complication
  • Dry eye disease
  • History of ocular trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophtalmology, Alexandria Main University Hospital (AMUH)

Alexandria, Egypt

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Mohammed H. F. Ghoneem, MD

    Department of Ophthalmology, Faculty of Medicine, University of Alexandria,

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

June 5, 2019

Study Start

January 1, 2018

Primary Completion

June 2, 2019

Study Completion

September 2, 2019

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)