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

NCT ID: NCT06708806

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-07

Study Completion Date

2022-11-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intra-individual comparison of the biocompatibility of two different IOLs. Investigated IOLs will be implanted subsequently according to the study protocol with one IOL type in the eye with no astigmatism and the other IOL type in the eye with astigmatism.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Toric vs Monofocal IOL

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)

Group Type OTHER

cataract surgery

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cataract surgery

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)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christina Leydolt

Assoc. Prof. Priv. Doz. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Vienna

Vienna, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2060/2019

Identifier Type: OTHER

Identifier Source: secondary_id

HOPP

Identifier Type: -

Identifier Source: org_study_id