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Completed

NCT Number: NCT03223857

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

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

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Key information

Conditions

Visual Acuity Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of ophthalmology University clinic Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femtosecond-laser-assisted lens exchange

Procedure

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

Primary outcomes

  1. Best corrected visual acuity at intermediate distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular corrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

Secondary outcomes

  1. Best corrected visual acuity at far distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular best corrected visual acuity at far distance measured in logMAR 3 month after lens surgery

  2. Best corrected visual acuity at near distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular best corrected visual acuity at near distance measured in logMAR 3 month after lens surgery

  3. Uncorrected visual acuity at far distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular uncorrected visual acuity at far distance measured in logMAR 3 month after lens surgery

  4. Uncorrected visual acuity at intermediate distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular uncorrected visual acuity at intermediate distance measured in logMAR 3 month after lens surgery

  5. Uncorrected visual acuity at near distance

    Time frame: Measured 3 month after lens surgery

    Monocular and binocular uncorrected visual acuity at near distance measured in logMAR 3 month after lens surgery

  6. Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions

    Time frame: 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)

  7. Defocus curve testing

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Clinic Frankfurt

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Jul 21, 2017
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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