To Evaluate the Visual Performance After Bilateral Implantation of Multifocal Intraocular Lenses

Visual Performance of Multifocal Intraocular Lenses Following Removal of the Crystalline Lens

To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Procedure: Femtosecond-laser-assisted lens exchange

Detailed Description

This study evaluates the visual performance after bilateral implantation of multifocal intraocular lenses (IOL). This prospective study is performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.

Patients who received bilateral implantation of a multifocal intraocular lens pre-enrollment were included consecutively. Exclusion criteria were previous ocular surgeries excluding cataract surgery and refractive lens exchange, regular corneal astigmatism of >1.5 diopter, and ocular pathologies or corneal abnormalities. At 3 months postoperative examination included manifest refraction; monocular and binocular uncorrected (UCVA) and distance-corrected (DCVA) visual acuity in at far, intermediate at near distance (logMAR); slit-lamp examination. 3 months postoperatively defocus testing, binocular contrast sensitivity (CS) under photopic and mesopic conditions, and a questionnaire on subjective quality of vision, optical phenomena, and spectacle independence were performed.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Department of ophthalmology University clinic Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who received bilateral cataract surgery or refractive lens exchange with the implantation of a multifocal intraocular lens

Description

Inclusion Criteria:

• bilateral cataract surgery or refractive lens exchange with the implantation a multifocal intraocular lens
• a regular corneal astigmatism < 1.5 D measured with Pentacam (Oculus, Wetzlar, Germany)

Exclusion Criteria:

• other previous ocular surgeries
• ocular pathologies
• corneal abnormalities
• endothelial cell count below 2000/mm²

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity at intermediate distance	Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity at near distance	Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Uncorrected visual acuity at far distance	Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Uncorrected visual acuity at intermediate distance	Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Uncorrected visual acuity at near distance	Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Defocus curve testing	Defocus curve (monocular and binocular) was tested from -5.0 D to +2.0 D in 0.5 D steps under photopic lighting conditions (ETDRS).	Measured 3 month after lens surgery
Best corrected visual acuity at far distance	Monocular and binocular best corrected visual acuity at far distance measured in logMAR 3 month after lens surgery	Measured 3 month after lens surgery
Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions	Binocular contrast sensitivity (CS) was measured under photopic, mesopic (0.167 cd/m²), and mesopic with glare lighting conditions by means of the "Frankfurt-Freiburg Contrast and Acuity Test System" (FF-CATS)	Measured 3 month after lens surgery

Collaborators and Investigators

• Sponsor: University Clinic Frankfurt
• Investigators: Study Chair: Thomas Kohnen, Professor, Goethe University Clinic Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2013
• Primary Completion (Actual): December 23, 2018
• Study Completion (Actual): March 23, 2019

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: patient satisfaction; multifocal intraocular lens; visual outcomes; spectacle independence
• Other Study ID Numbers: 102/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No