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OpenTrials
Completed

NCT Number: NCT06708806

Cell Ongrowth and Biocompatibility Study of Two Different (Hydrophobic Acrylic) Intraocular Lenses: IOL XY1 vs. IOL XY1A

The investigational devices are approved intraocular lenses (IOLs) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Cataract surgery with precedent bilateral randomized IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved investigational plan.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation is planned
  • Age 40 and older
  • Astigmatism of at least 0.75Diopters in one eye
  • Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion criteria

  • Diabetes mellitus
  • Pseudoexfoliation syndrome
  • Systemical anticoagulation
  • Antiphlogistic therapy
  • Antiglaucomatosa
  • Uncontrolled systemic or ocular disease
  • Preceding ocular surgery or trauma
  • Intraoperative complications
  • Pregnancy/Nursing
  • Concurrently participating in any other clinical trial or if they have participated in any other clinical trial during the last 30 days

Treatment and study plan

cataract surgery

Procedure

bilateral cataract surgery including phacoemulsification in individuals suffering from age-related cataract and intraocular lens implantation of a monofocal IOL (XY1) vs. an toric IOL (XY1A)

Primary outcomes

  1. Foreign Body Giant Cells

    Time frame: 6 weeks

    The primary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 6 weeks follow up.

Secondary outcomes

  1. Foreign Body Giant Cells

    Time frame: 5 months

    The first secondary objective is to assess the difference in Foreign Body Giant Cells between monofocal and toric lenses in every patient at 1 week and 5 months follow up.

  2. small round cells

    Time frame: 5 months

    The second secondary objective is to assess the difference in small round cells between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.

  3. PCO

    Time frame: 5 months

    The third secondary objective is to assess the difference in PCO between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.

  4. anterior chamber reaction

    Time frame: 5 months

    The fourth secondary objective is to assess the difference in the anterior chamber reaction between monofocal and toric lenses in every patient at 1 week, 6 weeks and 5 months follow up.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

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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