Clinical trial NCT03223857: To Evaluate the Visual Performance After Bilateral Implantation of Multifocal Intraocular Lenses
Official title: Visual Performance of Multifocal Intraocular Lenses Following Removal of the Crystalline Lens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Keywords: visual outcomes
multifocal intraocular lens
patient satisfaction
spectacle independence
Lead sponsor: University Clinic Frankfurt
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received bilateral cataract surgery or refractive lens exchange with the implantation of a multifocal intraocular lens

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.

Eligibility criteria: 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

Primary outcomes:
measure: Best corrected visual acuity at intermediate distance
timeFrame: Measured 3 month after lens surgery
Secondary outcomes:
measure: Best corrected visual acuity at far distance
timeFrame: Measured 3 month after lens surgery
measure: Best corrected visual acuity at near distance
timeFrame: Measured 3 month after lens surgery
measure: Uncorrected visual acuity at far distance
timeFrame: Measured 3 month after lens surgery
measure: Uncorrected visual acuity at intermediate distance
timeFrame: Measured 3 month after lens surgery
measure: Uncorrected visual acuity at near distance
timeFrame: Measured 3 month after lens surgery
measure: Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions
timeFrame: Measured 3 month after lens surgery
measure: Defocus curve testing
timeFrame: Measured 3 month after lens surgery
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of ophthalmology University clinic Frankfurt
state: Hessen
Study officials:
affiliation: Goethe University Clinic Frankfurt
name: Thomas Kohnen, Professor
role: STUDY_CHAIR
References: