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CataractNCT04907318

Comparison Between a Toric Monofocal and Multifocal Intraocular Lens

An observational study of Cataract, run by Beaver-Visitec International, Inc. at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Cataract
What is being tested?
Cataract surgery
Type of treatment
Medical device
How many people
60 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2016to 1 Jul 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • Cataract (with or without presbyopia)
  • No pre-existing ocular pathology or history of ocular surgery
  • No phacodonesis
  • PEX patients (pseudoexfoliation syndrome) can be included.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Vista Alpina Eye Center

    Visp, 3930

Other trials in Switzerland

About this study

Official title: Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.

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.

Conditions
Cataract
Being tested
Cataract surgery
Keywords
IOL, Toric, Multifocal
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cataract surgeryDevice

Study groups in NCT04907318
Study groupRoleWhat they receive
ANKORISCataract surgery performed with POD26PAYT
Receives: Device: Cataract surgery
FINEVISION TORICCataract surgery performed with POD26PAYFT
Receives: Device: Cataract surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To observe the rotational stability of the implant

    Observation of rotational stability of the implant

    Measured: 6 Months

Secondary outcomes (1)
  1. Visual Acuity

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

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2021
  2. Study start1 Jan 2016
  3. Primary completion1 Jun 2016
  4. Study completion1 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907318
Sponsor's protocol ID
PHY PODT-POD FT
Status last verified
May 2021
First submitted
25 May 2021
Last updated
2 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by Beaver-Visitec International, Inc. at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To observe the rotational stability of the implant (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.

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