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Clinical Trials/NCT03223857
NCT03223857
Completed
Not Applicable

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

University Clinic Frankfurt1 site in 1 country60 target enrollmentApril 9, 2013
ConditionsVisual Acuity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Visual Acuity
Sponsor
University Clinic Frankfurt
Enrollment
60
Locations
1
Primary Endpoint
Best corrected visual acuity at intermediate distance
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 9, 2013
End Date
March 23, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Clinic Frankfurt
Responsible Party
Principal Investigator
Principal Investigator

Myriam Böhm, MD

Professor Dr. med. Thomas Kohnen

University Clinic Frankfurt

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

Outcomes

Primary Outcomes

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

  • Best corrected visual acuity at far distance(Measured 3 month after lens surgery)
  • Best corrected visual acuity at near distance(Measured 3 month after lens surgery)
  • Uncorrected visual acuity at far distance(Measured 3 month after lens surgery)
  • Uncorrected visual acuity at near distance(Measured 3 month after lens surgery)
  • Defocus curve testing(Measured 3 month after lens surgery)
  • Uncorrected visual acuity at intermediate distance(Measured 3 month after lens surgery)
  • Binocular contrast sensitivity (CS) under photopic, mesopic, and mesopic with glare lighting conditions(Measured 3 month after lens surgery)

Study Sites (1)

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