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OpenTrials
Completed

NCT Number: NCT02990689

Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.

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Key information

Conditions

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of any gender, aged 50 to 80 years
  • Signed informed consent form
  • Healthy eyes besides cataract
  • Assured follow-up examinations
  • Stable corneal conditions within the last 12 months
  • Corneal astigmatism less than 1D
  • Implantation into the capsular bag by injector

Exclusion criteria

  • Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
  • Pseudophakia
  • Cornea guttata; keratoplasty
  • Irregular astigmatism (e.g. Keratoconus)
  • Corneal scarring
  • Diabetic retinopathy
  • Aniridia
  • Amblyopia
  • Amotio operation; anamnesis with vitreous surgery
  • Pseudoexfoliation Syndrome; Uveitis
  • Previous intraocular and corneal surgery
  • Intraocular tumours; endotamponade
  • Glaucoma or IOP higher than 24mmHg
  • Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to > 0.3 logMAR
  • Need for a dioptre out of the range of +16.0D to +26.0D
  • Inability to achieve secure lens placement in the capsular bag
  • Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
  • Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
  • Pregnancy or lactation period for female patients

Treatment and study plan

Trifocal Intraocular lens

Device

bifocal intraocular lens (IOL)

Bifocal Intraocular Lens

Device

trifocal intraocular lens (IOL)

Low Addition Bifocal Intraocular Lens

Device

low near addition intraocular lens (IOL)

Primary outcomes

  1. Intermediate visual acuity

    Time frame: 12 months

Secondary outcomes

  1. Distance visual acuity

    Time frame: 12 months

  2. Near visual acuity

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 13, 2016
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.