NCT03347981

Brief Summary

Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material

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 Oct 2017

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 26, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2019

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

1.6 years

First QC Date

September 26, 2017

Last Update Submit

May 5, 2021

Conditions

CataractLens OpacitiesPresbyopia

Keywords

Intraocular Lenstrifocalhydrophobichydrophilic

Outcome Measures

Primary Outcomes (1)

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

    The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014

    3 months postoperative

Secondary Outcomes (17)

  • Manifested refraction - Sphere

    3 months postoperative

  • Manifested refraction - Cylinder

    3 months postoperative

  • Uncorrected Distance Visual Acuity (UDVA)

    3 months postoperative

  • Corrected Distance Visual Acuity (CDVA)

    3 months postoperative

  • Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)

    3 months postoperative

  • +12 more secondary outcomes

Study Arms (2)

IOL implantation experimental

EXPERIMENTAL

hydrophobic, trifocal intraocular lens POD F GF

Device: IOL implantation experimental

IOL implantation active comparator

ACTIVE COMPARATOR

hydrophilic, trifocal intraocular lens POD F

Device: IOL implantation active comparator

Interventions

IOL implantation experimentalDEVICE

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL implantation experimental
IOL implantation active comparatorDEVICE

Implantation of trifocal IOL POD F consisting of hydrophilic material

IOL implantation active comparator

Eligibility Criteria

Age50 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 \< 50 years
  • Regular corneal astigmatism \>1.00 dioptres by an automatic keratometer or biometer or \>1.25 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)

Innova Ocular IOA Madrid

Madrid, 28003, Spain

Location

MeSH Terms

Conditions

CataractPresbyopia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Francisco Poyales Galan, MD

    Innova Ocular IOA Madrid

    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, 2017

First Posted

November 20, 2017

Study Start

October 2, 2017

Primary Completion

May 21, 2019

Study Completion

May 21, 2019

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)