Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

Not Applicable

Completed

• Conditions: Visual Acuity
• Interventions: Device: Bifocal Intraocular Lens; Device: Trifocal Intraocular Lens; Device: Low Addition Bifocal Intraocular Lens

• Registration Number: NCT02990689
• Lead Sponsor: Carl Zeiss Meditec AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2015-04
• Study Completion: 2015-10
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-13
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
809M	Bifocal Intraocular Lens	bifocal intraocular lens (IOL)
839MP	Trifocal Intraocular Lens	trifocal intraocular lens (IOL)
SN6AD1	Low Addition Bifocal Intraocular Lens	bifocal intraocular lens (IOL)

Primary Outcome Measures

Name	Time	Method
Intermediate visual acuity	12 months

Secondary Outcome Measures

Name	Time	Method
Distance visual acuity	12 months
Near visual acuity	12 months