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

Medical University of Vienna50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cataract

Interventions

cataract surgeryPROCEDURE

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)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

Foreign Body Giant Cells

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.

Time frame: 6 weeks

Secondary Outcomes

Foreign Body Giant Cells

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.

Time frame: 5 months

small round cells

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.

Time frame: 5 months

PCO

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.

Time frame: 5 months

anterior chamber reaction

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.

Time frame: 5 months

Data from ClinicalTrials.gov

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