Evaluation of Physiological Responses at the Anterior Surface of Two (Hydrophobic Acrylic) Intraocular Lens Models

NCT04230629 | Unknown DMC

• 1 other identifier: 2060/2019
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

On the day of surgery, the the eye with astigmatism of at least 0.75dpt receives a Vivinex XY1A , HOYA Surgical Optics GmbH and the second eye to be operated receives an XY1, HOYA Surgical Optics GmbH. A complete biomicroscopic examination and visual acuity testing using autorefractometer, will be performed 1 week (7-14days), 6 weeks (30-60days) and 5 month (4-6months) postoperatively.

Conditions

Age Related Cataracts

Outcome Measures

Primary Outcomes (1)

• Number of FBGC (foreign body giant cells) (slitlamp examination)

  The number of foreign body giant cells on the IOLs will be assessed.

  5 months

Secondary Outcomes (4)

• Incidence of Monocytes (slitlamp examination)

  5 months

• PCO Score (slitlamp examination)

  5 months

• Grade of Anterior Fibrosis (slitlamp examination)

  5 months

• Anterior chamber reaction (slitlamp examination)

  5 months

Study Arms (2)

Vivinex XY1

ACTIVE COMPARATOR

Implantation of an intraocular lens Hoya Vivinex XY1

Device: Vivinex XY1

Vivinex XY1A

ACTIVE COMPARATOR

Implantation of an intraocular lens Hoya Vivinex XY1A

Device: Vivinex XY1A

Interventions

Vivinex XY1 DEVICE

Implantation of an intraocular lens Hoya Vivinex XY1

Vivinex XY1

Vivinex XY1A DEVICE

Implantation of an intraocular lens Hoya Vivinex XY1A

Vivinex XY1A

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

Central Study Contacts

Rupert Menapace

CONTACT

0140400; rupert.menapace@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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 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 on subjects and includes: visual acuity, slitlamp examination.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: March 15, 2021
• Primary Completion: December 30, 2021
• Study Completion: June 30, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share