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A-constant Optimization of a Toric Monofocal IOL

B

Beaver-Visitec

Status

Completed

Conditions

Cataract

Treatments

Device: Ankoris

Study type

Observational

Funder types

Industry

Identifiers

NCT04944238
PHY2014

Details and patient eligibility

About

The study is a prospective series study to determine the IOL constant of a hydrophilic toric monofocal intra-ocular lens (IOL)

Full description

The study is a prospective series study with he principal objective to determine the IOL constant.

The secondary objectives of this study are to determine the rotational stability of the Ankoris intraocular lens and to measure the residual astigmatism after Ankoris IOL implantation with respect to the targeted astigmatism correction.

Although there may be no direct benefit to the subjects under study, the investigation will determined the optimized constant for accurate IOL power calculation and will assess the stability and efficacy of the toric optics: this would result in a benefit for the patient population. Since the material, the overall design of the IOL as well as the measuring procedure in this study is well tolerated in standard clinical practice and the IOL is readily available and CE-marked, the benefit/risk ratio appears acceptable.

Enrollment

78 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patient older than 50 years old
  • Age-related cataract
  • Corneal astigmatisme >1 D
  • Age 21 and older
  • Visual Acuity > 0.05
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.

Exclusion criteria

  • Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies
  • Previous ocular surgery or trauma.

Trial design

78 participants in 1 patient group

Patients implanted with Ankoris IOL
Description:
To assess the IOL stability, slitlamp photos of the consecutive 30 patients with respect to time will then be analysed with a 5% confidence interval.
Treatment:
Device: Ankoris

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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