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

Not Applicable

Completed

• Conditions: Cataract

• Registration Number: NCT06708806
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-07
• Primary Completion: 2022-11-11
• Study Completion: 2022-11-11
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Foreign Body Giant Cells	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 Outcome Measures

Name	Time	Method
Foreign Body Giant Cells	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.
small round cells	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.
PCO	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.
anterior chamber reaction	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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria