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OpenTrials
Completed

NCT Number: NCT04740788

Study on Visual Performance of a Monofocal Intraocular Lens

Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL). The objective is to compare best corrected distance visual acuity (CDVA) between 1-3-month and 12- month follow-up.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Borkenstein & Borkenstein

Graz, 8010, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older;
  • Patients with monolateral or bilateral (only one eye will be the study eye) monofocal IOL implantation after uncomplicated surgery in the period between May 2019 and November 2019, if the follow-up visit can be performed 10-18 months after surgery;
  • No visual acuity limiting pathologies;
  • Availability of 1-3-month postoperative data
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures in case of a prospective 12-month visit;
  • Written informed consent for participation in the study and data protection.

Exclusion criteria

  • Difficulty for cooperation (distance from their home, general health conditions)
  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that would confound visual acuity measurements;
  • Subjects with surgical complications or secondary interventions (except for Nd:YAG capsulotomy) related to the cataract surgery of the monofocal IOL eye(s) or any other interventions in the post-operative eye including but not limited to glaucoma surgery, retinal surgery;
  • Visual field loss which has impact on visual acuity;
  • Use of systemic or ocular medication that might affect vision;
  • Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
  • Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome);
  • Concurrent participation in another device investigation.

Treatment and study plan

Monofocal IOL

Device

Patients are already implanted with a monofocal lens

Primary outcomes

  1. Best corrected distance visual acuity (CDVA)

    Time frame: 12 months

    Comparison between 1-3-month and 12- month follow-up results.

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

Multicentric Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Aug 17, 2021

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.

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