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

Medical University of Vienna

Status: Unknown

Conditions: Age Related Cataracts

Treatments: Device: Vivinex XY1A; Device: Vivinex XY1

Study type: Interventional

Funder types: Other

Identifiers

NCT04230629

2060/2019

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Vivinex XY1

Active Comparator group

Description:

Implantation of an intraocular lens Hoya Vivinex XY1

Treatment:

Device: Vivinex XY1

Vivinex XY1A

Active Comparator group

Description:

Implantation of an intraocular lens Hoya Vivinex XY1A

Treatment:

Device: Vivinex XY1A