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CompletedNCT04907318Updated Jun 2, 2021

Comparison Between a Toric Monofocal and Multifocal Intraocular Lens

An observational study in Cataract, sponsored by Beaver-Visitec International, Inc.. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-06-02.

Sponsored by Beaver-Visitec International, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The primary objective of the study is to observe the rotational stability of the implant 30 minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the refraction will be measured as it is directly affected in the event of postoperative rotation. The correlation between postoperative rotation and the following parameters will be determined: PEXS, white-to-white, age, axial length, anterior chamber depth. Visual acuities with and without correction and the best refraction to assess the benefit of the implants will also be investigated.

Read the detailed description

This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.

Inclusion criteria for research participants.

  • Cataract (with or without presbyopia)
  • No pre-existing ocular pathology or history of ocular surgery
  • No phacodonesis

PEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.

In particular the patients with the following pathologies will be excluded:

  • Irregular astigmatism.
  • Cases of uncontrolled glaucoma.
  • Intraocular inflammation.
  • Narrow anterior chambers (2.5 mm).
  • Amblyopia with potential visual acuity less than 5/10.
  • Any corneal pathology potentially affecting topography (e.g., keratoconus).
  • Patients with a history of corneal surgery (especially refractive surgery).
  • Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
  • Patients with a history of ocular trauma.
  • Pathological miosis.
  • Patients with zonular laxity.
  • Patients suffering from chronic uveitis.
  • Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.

    3 - Adopted observation or investigation method This study involves the collection of data in patient records that fall within the normal framework of cataract surgery.

The demographic and clinical data collected will be the yeat of birth and patient's gender, including ocular or general comorbidities (such as diabetes or rheumatoid illnesses) justifying the visual acuity performance.

The preoperative data collected will be: visual acuity, intraocular pressure, cell density of the corneal endothelium, axial length and corneal power in both axes (data required to routinely calculate the power of the implant and entered into the record to understand any postoperative refractive errors).

The intraoperative data will be the power of the implant and any complications, if applicable.

The postoperative data will be data collected during the standard postoperative follow-up performed at 30 minutes, 1 day, one week, 6 weeks, 6 months and 1 year, with patient questioning, slit lamp observation with implant position, measuring intraocular pressure, determining the best refraction and measuring visual acuity with and without correction (near, far and intermediate vision).

4 - Origin and nature of collected personal data Reason for using this data Observations will be obtained by the doctor from patient records. Clinical data will be used to link potential poor postoperative visual acuity and a comorbidity.

Refractive data will help determine the implant stability in the eye in terms of its depth, i.e. in the sagittal plane, and its rotational stability, i.e. coronal plane stability.

Changes will determine its stability in the coronal plane around the visual axis.

The intraocular pressure analysis and slit lamp examination will help determine the eye inflammatory status before and after surgery.

The record of postoperative keratometry values will help determine whether the error or a refractive change caused by the corneal instability or by the change in the implant position.

02

Conditions studied

  • Cataract

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Keywords

  • IOL
  • Toric
  • Multifocal
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 60 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher and had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.

Inclusion criteria

  • Cataract (with or without presbyopia)
  • No pre-existing ocular pathology or history of ocular surgery
  • No phacodonesis

PEX patients (pseudoexfoliation syndrome) can be included.

Exclusion criteria

Exclusion Criteria:

To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.

In particular the patients with the following pathologies will be excluded:

  • Irregular astigmatism.
  • Cases of uncontrolled glaucoma.
  • Intraocular inflammation.
  • Narrow anterior chambers (2.5 mm).
  • Amblyopia with potential visual acuity less than 5/10.
  • Any corneal pathology potentially affecting topography (e.g., keratoconus).
  • Patients with a history of corneal surgery (especially refractive surgery).
  • Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.
  • Patients with a history of ocular trauma.
  • Pathological miosis.
  • Patients with zonular laxity.
  • Patients suffering from chronic uveitis.
  • Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • ANKORIS

    Cataract surgery performed with POD26PAYT

    Device: Cataract surgery

  • FINEVISION TORIC

    Cataract surgery performed with POD26PAYFT

    Device: Cataract surgery

Interventions

  • DeviceCataract surgery
06

What researchers measure

Primary outcomes

  1. To observe the rotational stability of the implant

    Observation of rotational stability of the implant

    Time frame: 6 Months

Secondary outcomes

  1. Visual Acuity

    To assess the visual acuities with and without correction and the best refraction to assess the benefit of the implants

    Time frame: 6 Months

07

Study locations

1 site
  • Vista Alpina Eye Center
    Visp, 3930, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04907318
Lead sponsor
Beaver-Visitec International, Inc.
Responsible party
Sponsor
First posted
May 28, 2021
Start date
Jan 1, 2016
Primary completion
Jun 1, 2016
Completion
Jul 1, 2016
Last update
Jun 2, 2021

Study contacts

Kristof Vandekerckhove, MD
principal investigator · Vista Alpina Eye Cente, Visp, Switzerland, 3930

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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