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

NCT06708806 | Completed

• 2 other identifiers: HOPP2060/2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Biocompatibility

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (4)

• Foreign Body Giant Cells

  5 months

• small round cells

  5 months

• PCO

  5 months

• anterior chamber reaction

  5 months

Study Arms (1)

Toric vs Monofocal IOL

OTHER

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)

Procedure: cataract surgery

Interventions

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)

Toric vs Monofocal IOL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Priv. Doz. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 27, 2024
• Study Start: April 7, 2021
• Primary Completion: November 11, 2022
• Study Completion: November 11, 2022
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

AU (1)