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

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Age Related Cataracts

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vivinex XY1

Implantation of an intraocular lens Hoya Vivinex XY1

Group Type ACTIVE_COMPARATOR

Vivinex XY1

Intervention Type DEVICE

Implantation of an intraocular lens Hoya Vivinex XY1

Vivinex XY1A

Implantation of an intraocular lens Hoya Vivinex XY1A

Group Type ACTIVE_COMPARATOR

Vivinex XY1A

Intervention Type DEVICE

Implantation of an intraocular lens Hoya Vivinex XY1A

Interventions

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Vivinex XY1

Implantation of an intraocular lens Hoya Vivinex XY1

Intervention Type DEVICE

Vivinex XY1A

Implantation of an intraocular lens Hoya Vivinex XY1A

Intervention Type DEVICE

Eligibility Criteria

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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