Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens

Visual Outcomes After Implantation of a Segmental Refractive Multifocal Intraocular Lens Following Cataract Surgery

To evaluate visual outcomes of a segmental refractive multifocal intraocular lens (IOL) after cataract surgery.

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Other: Implantation of multifocal intraocular lens

Detailed Description

Purpose: This prospective, nonrandomized noncomparative case series investigates the visual performance after bilateral implantation of a segmental refractive multifocal intraocular lenses (IOL) after cataract surgery and was performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.

Methods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age > 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift < 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR,

Intervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months.

Main Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.

• Study Type: Observational
• Enrollment (Actual): 25

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: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• bilateral cataract
• age > 45 years
• corneal astigmatism ≤ 0.75 D postoperatively
• pupil size 3 to 6 mm (mesopic)
• center shift < 1 mm

Exclusion Criteria:

• previous ocular surgeries
• amblyopia
• potential postoperative distance-corrected visual acuity (DCVA) < 0.3 logMAR

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity at far distance	Monocular and binocular corrected visual acuity at far 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 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
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
Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions	Binocular contrast sensitivity (CS) was measured with the Functional Acuity Contrast Test (FACT) chart in the Optec 6500 Vision Tester (Stereo Optical Co., Chicago, IL) under binocular photopic (85 cd/m²), mesopic (3 cd/m²), and photopic and mesopic with glare conditions at a spatial frequency of 6 cycles per degree (cpd) (threshold range 0.78-2.26).	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
Radner reading skills	Binocular distance-corrected reading acuity (40 cm) was investigated in LogRAD (Reading Acuity Determination) using reading charts (Radner Reading Charts).	Measured 3 month after lens surgery
Optical quality questionnaire	Quality of vision questionnaire (visual analogue scale (VAS) 0 (perfect / no symptoms) to 100 (extremely poor / maximum symptom intensity)) asking for evaluation of "glare", "halos", "starbursts", "blurred vision", and "ghosting" under photopic, mesopic and scotopic light conditions, if they wear any spectacles, and to evaluate their total quality of vision.	Measured 3 month after lens surgery

Collaborators and Investigators

• Sponsor: University Clinic Frankfurt
• Collaborators: Oculentis GmbH
• Investigators: Principal Investigator: Thomas Kohnen, Professor, Goethe University Clinic Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: patient satisfaction; contrast sensitivity; visual outcomes; mulitfocal intraocular lens; spectacle independence
• Other Study ID Numbers: 153/14

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