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Posterior Capsule Opafication of Two Different Hydrophobic Acrylic Intraocular Lenses

NCT ID: NCT04196673

Last Updated: 2019-12-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2019-08-23

Brief Summary

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On the day of surgery, the first eye to be operated is randomised to receive a Vivinex , HOYA Surgical Optics GmbH or an SN60WF, Alcon, Fort Worth, Texas. The second eye to be operated receives the other IOL type.

A complete biomicroscopic examination, visual acuity testing using autorefractometer, contrast sensitivity testing, and standardised retroillumination photography for PCO evaluation, will be performed 6 month (30-60 days), 1.5 years (± 3 months) and 3 (± 3 months) years postoperatively.

Detailed Description

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Conditions

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Age Related Cataracts

Study Design

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Allocation Method

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 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 on subjects and includes: visual acuity, slitlamp examination, fibrosis, posterior capsule opacification (PCO) score and YAG capsulotomy rate.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Alcon SN60WF

Implantation of an intraocular lens Alcon SN60WF

Group Type EXPERIMENTAL

Alcon SN60WF

Intervention Type DEVICE

Implantation of an intraocular lens Alcon SN60WF

Hoya Vivinex

Implantation of an intraocular lens Hoya Vivinex

Group Type EXPERIMENTAL

Hoya Vivinex

Intervention Type DEVICE

Implantation of an intraocular lens Hoya Vivinex

Interventions

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Alcon SN60WF

Implantation of an intraocular lens Alcon SN60WF

Intervention Type DEVICE

Hoya Vivinex

Implantation of an intraocular lens Hoya Vivinex

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 50 and older
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria

* Preceding intraocular surgery or ocular trauma
* Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, uveitis, retinal degenerations, etc.)
* Laser treatment
* Uncontrolled systemic or ocular disease
* Infectious disease
* Pregnancy/Nursing
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Rupert Menapace

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rupert Menapace, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Other Identifiers

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1560/2014

Identifier Type: -

Identifier Source: org_study_id