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

Completed

• Conditions: Visual Acuity

• Registration Number: NCT03223857
• Lead Sponsor: University Clinic Frankfurt

Brief Summary

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

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 Timeline

• Study Start: 2013-04-09
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Primary Completion: 2018-12-23
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Study Completion: 2019-03-23
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity at intermediate distance	Measured 3 month after lens surgery	Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity at far distance	Measured 3 month after lens surgery	Monocular and binocular best corrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Best corrected visual acuity at near distance	Measured 3 month after lens surgery	Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery
Uncorrected visual acuity at far distance	Measured 3 month after lens surgery	Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Uncorrected visual acuity at near distance	Measured 3 month after lens surgery	Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery
Defocus curve testing	Measured 3 month after lens surgery	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).
Uncorrected visual acuity at intermediate distance	Measured 3 month after lens surgery	Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery
Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions	Measured 3 month after lens surgery	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)

Trial Locations

Locations (1)

Department of ophthalmology University clinic Frankfurt; 🇩🇪 Frankfurt am Main, Hessen, Germany