Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to compare the performances of 2 bifocal IOLs and 1 trifocal IOL for far, near and intermediate vision.

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Detailed Description

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Conditions

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Visual Acuity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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809M

bifocal intraocular lens (IOL)

Group Type ACTIVE_COMPARATOR

Bifocal Intraocular Lens

Intervention Type DEVICE

trifocal intraocular lens (IOL)

839MP

trifocal intraocular lens (IOL)

Group Type ACTIVE_COMPARATOR

Trifocal Intraocular Lens

Intervention Type DEVICE

bifocal intraocular lens (IOL)

SN6AD1

bifocal intraocular lens (IOL)

Group Type ACTIVE_COMPARATOR

Low Addition Bifocal Intraocular Lens

Intervention Type DEVICE

low near addition intraocular lens (IOL)

Interventions

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Trifocal Intraocular Lens

bifocal intraocular lens (IOL)

Intervention Type DEVICE

Bifocal Intraocular Lens

trifocal intraocular lens (IOL)

Intervention Type DEVICE

Low Addition Bifocal Intraocular Lens

low near addition intraocular lens (IOL)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients of any gender, aged 50 to 80 years
* Signed informed consent form
* Healthy eyes besides cataract
* Assured follow-up examinations
* Stable corneal conditions within the last 12 months
* Corneal astigmatism less than 1D
* Implantation into the capsular bag by injector

Exclusion Criteria

* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)
* Pseudophakia
* Cornea guttata; keratoplasty
* Irregular astigmatism (e.g. Keratoconus)
* Corneal scarring
* Diabetic retinopathy
* Aniridia
* Amblyopia
* Amotio operation; anamnesis with vitreous surgery
* Pseudoexfoliation Syndrome; Uveitis
* Previous intraocular and corneal surgery
* Intraocular tumours; endotamponade
* Glaucoma or IOP higher than 24mmHg
* Phlogistic intraocular processes or other pre-existing processes that permanently limit the best corrected visual acuity to \> 0.3 logMAR
* Need for a dioptre out of the range of +16.0D to +26.0D
* Inability to achieve secure lens placement in the capsular bag
* Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient
* Intraoperative complications, damaged posterior bag, intraocular haemorrhage, can opener rhexis
* Pregnancy or lactation period for female patients

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes