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

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Medical University of Vienna

Status

Completed

Conditions

Cataract

Treatments

Procedure: cataract surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06708806
HOPP
2060/2019

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Toric vs Monofocal IOL
Other group
Description:
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. In Arm one (I) participants will receive a monofocal IOL (XY1) vs. an toric IOL (XY1A)
Treatment:
Procedure: cataract surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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