NCT03306342

Brief Summary

Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration 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

First Submitted

Initial submission to the registry

September 27, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 2, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

2.8 years

First QC Date

September 27, 2017

Last Update Submit

January 7, 2022

Conditions

CataractLens OpacitiesPresbyopia

Keywords

Intraocular Lenstrifocalhydrophobichydrophilic

Outcome Measures

Primary Outcomes (1)

  • binocular Uncorrected Distance Visual Acuity (UDVA)

    Statistically significant equality between literature data and data obtained in this study on binocular UDVA. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014

    3 months postoperative

Secondary Outcomes (11)

  • Manifested refraction

    3 months postoperative

  • Uncorrected Distance Visual Acuity (UDVA)

    3 months postoperative

  • Corrected Distance Visual Acuity (CDVA)

    3 months postoperative

  • Distance Corrected Intermediate Visual Acuity (DCIVA)

    3 months postoperative

  • Uncorrected Intermediate Visual Acuity (UIVA)

    3 months postoperative

  • +6 more secondary outcomes

Study Arms (1)

IOL implantation experimental

EXPERIMENTAL

hydrophobic, trifocal intraocular lens POD F GF

Device: IOL implantation experimental

Interventions

IOL implantation experimentalDEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL implantation experimental

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataractous eyes with no comorbidity
  • Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

You may not qualify if:

  • Irregular astigmatism
  • Age of patient \< 45 years
  • Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
  • Difficulty for cooperation (distance from their home, general health condition)
  • Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
  • Any ocular comorbidity
  • History of ocular trauma or prior ocular surgery including refractive procedures
  • Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
  • AMD suspicious eyes (determined by OCT)
  • Complicated surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis

Brest, 29609, France

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Béatrice Cochener, Prof.

    Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis

    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

September 27, 2017

First Posted

October 11, 2017

Study Start

February 2, 2018

Primary Completion

November 10, 2020

Study Completion

November 11, 2020

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)