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

NCT ID: NCT03223857

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-09

Study Completion Date

2019-03-23

Brief Summary

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

Detailed Description

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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.

Conditions

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Visual Acuity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Femtosecond-laser-assisted lens exchange

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Clinic Frankfurt

OTHER

Sponsor Role lead

Responsible Party

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Myriam Böhm, MD

Professor Dr. med. Thomas Kohnen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Kohnen, Professor

Role: STUDY_CHAIR

Goethe University Clinic Frankfurt

Locations

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Department of ophthalmology University clinic Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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102/13

Identifier Type: -

Identifier Source: org_study_id

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