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OpenTrials
Completed

NCT Number: NCT03145103

Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses

Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology

Linköping, SE58252, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;
  • Patients of any gender
  • Assured follow-up examinations
  • Biometry measurement preferably compatible with the IOLMaster evaluation;
  • IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit
  • Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)

Exclusion criteria

  • BCVA not available preoperatively or better than 0.3 logMAR pre-op
  • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
  • Patients whose freedom is impaired by administrative or legal order
  • Concurrent participation in another drug or device investigation -

Treatment and study plan

CT ASPHINA 409

Device

intraocular lens

Primary outcomes

  1. Visual acuity

    Time frame: 12 to 18 months after surgery

    Monocular best corrected distance visual acuity

Sponsors and collaborators

Lead sponsor

Carl Zeiss Meditec AG

Industry

Registry information

Official study title

Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study

Acronym: UVEA409

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Jul 18, 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.

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