Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02990689

Enrollment

Registered

2016-12-13

Start date

2012-03-31

Completion date

2015-10-31

Last updated

2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Acuity

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.

Interventions

DEVICETrifocal Intraocular Lens

bifocal intraocular lens (IOL)

DEVICEBifocal Intraocular Lens

trifocal intraocular lens (IOL)

DEVICELow Addition Bifocal Intraocular Lens

low near addition intraocular lens (IOL)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Intermediate visual acuity	12 months

Secondary

Measure	Time frame
Distance visual acuity	12 months
Near visual acuity	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026