Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452969
• Other study ID #: 153/14
• Status: Completed
• Start date: August 28, 2014
• Est. completion date: May 1, 2018

Study information

• Verified date: October 2018
• Source: University Clinic Frankfurt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Other:
• Implantation of multifocal intraocular lens
Procedure/Surgery: Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.

Locations

Country	Name	City	State
Germany	Department of ophthalmology University clinic Frankfurt	Frankfurt am Main	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
University Clinic Frankfurt	Oculentis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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