NCT03688399

Brief Summary

Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

Study Start

First participant enrolled

July 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2021

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

2.5 years

First QC Date

September 26, 2018

Last Update Submit

January 7, 2022

Conditions

CataractLens OpacityPresbyopia

Keywords

Intraocular LenstrifocalcataractPhysIOL

Outcome Measures

Primary Outcomes (1)

  • Monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.

    No statistically significant difference between the two study groups on monocular CDVA at 3 months follow up visit. A significance level of 0.05 or lower (p \< 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014.

    3 months postoperative

Secondary Outcomes (18)

  • Manifested refraction

    3 months postoperative

  • Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

    3 months postoperative

  • Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions

    6 months postoperative

  • Corrected Distance Visual Acuity (CDVA) under photopic light conditions

    3 months postoperative

  • Corrected Distance Visual Acuity (CDVA) under mesopic light conditions

    6 months postoperative

  • +13 more secondary outcomes

Study Arms (2)

IOL Implantation experimental

EXPERIMENTAL

hydrophobic, trifocal intraocular lens POD L GF with light distribution far \> intermediate \> near

Device: IOL implantation experimental

IOL Implantation Comparator

ACTIVE COMPARATOR

hydrophobic, trifocal intraocular lens POD F GF with light distribution far \> near \> intermediate

Device: IOL implantation comparator

Interventions

IOL implantation experimentalDEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> intermediate \> near

IOL Implantation experimental
IOL implantation comparatorDEVICE

Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate

IOL Implantation Comparator

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cataractous eyes and/or patients suffering from presbyopia with no ocular comorbidity
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

You may not qualify if:

  • Age of patient \<40 years
  • Irregular astigmatism
  • 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°
  • 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
  • Complicated surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University - Department of Ophthalmology

Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Zoltan Nagy, MD

    Semmelweis University - Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 26, 2018

First Posted

September 28, 2018

Study Start

July 30, 2018

Primary Completion

February 1, 2021

Study Completion

September 21, 2021

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)