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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03223857
Enrollment
60
Registered
2017-07-21
Start date
2013-04-09
Completion date
2019-03-23
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Acuity

Keywords

visual outcomes, multifocal intraocular lens, patient satisfaction, spectacle independence

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.

Interventions

PROCEDUREFemtosecond-laser-assisted lens exchange

Bilateral implantation of multifocal intraocular lens (MIOL) following femtosecond-laser-assisted lens exchange

Sponsors

University Clinic Frankfurt
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Best corrected visual acuity at intermediate distanceMeasured 3 month after lens surgeryMonocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

Secondary

MeasureTime frameDescription
Best corrected visual acuity at near distanceMeasured 3 month after lens surgeryMonocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery
Uncorrected visual acuity at far distanceMeasured 3 month after lens surgeryMonocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Uncorrected visual acuity at intermediate distanceMeasured 3 month after lens surgeryMonocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery
Best corrected visual acuity at far distanceMeasured 3 month after lens surgeryMonocular and binocular best corrected visual acuity at far distance measured in logMAR 3 month after lens surgery
Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditionsMeasured 3 month after lens surgeryBinocular 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)
Defocus curve testingMeasured 3 month after lens surgeryDefocus 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 near distanceMeasured 3 month after lens surgeryMonocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026