Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

Carl Zeiss Meditec

Status: Completed

Conditions: Visual Acuity

Treatments: Device: Bifocal Intraocular Lens; Device: Trifocal Intraocular Lens; Device: Low Addition Bifocal Intraocular Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02990689

LISA tri 839MP HEN 301-11

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

55 participants in 3 patient groups

809M

Active Comparator group

Description:

bifocal intraocular lens (IOL)

Treatment:

Device: Bifocal Intraocular Lens

839MP

Active Comparator group

Description:

trifocal intraocular lens (IOL)

Treatment:

Device: Trifocal Intraocular Lens

SN6AD1

Active Comparator group

Description:

bifocal intraocular lens (IOL)

Treatment:

Device: Low Addition Bifocal Intraocular Lens