Clinical Study to Evaluate the Visual Performance of Three Multifocal IOLs

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990689
• Other study ID #: LISA tri 839MP HEN 301-11
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 2015

Study information

• Verified date: September 2018
• Source: Carl Zeiss Meditec AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Trifocal Intraocular Lens
bifocal intraocular lens (IOL)
• Bifocal Intraocular Lens
trifocal intraocular lens (IOL)
• Low Addition Bifocal Intraocular Lens
low near addition intraocular lens (IOL)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carl Zeiss Meditec AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermediate visual acuity		12 months
Secondary	Distance visual acuity		12 months
Secondary	Near visual acuity		12 months