Visual Outcomes of a Segmental Refractive Multifocal Intraocular Lens
NCT ID: NCT03452969
Last Updated: 2018-10-10
Study Results
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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COMPLETED
25 participants
OBSERVATIONAL
2014-08-28
2018-05-01
Brief Summary
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Detailed Description
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Methods: Fifty eyes (25 patients) were included. Inclusion criteria were bilateral cataract, age \> 45 years, corneal astigmatism ≤ 0.75 D postoperatively, pupil size 3 to 6 mm (mesopic), and center shift \< 1 mm (Pentacam). Exclusion criteria were previous ocular surgeries, amblyopia or potential postoperative distance-corrected visual acuity (DCVA) \< 0.3 logMAR,
Intervention or Observation: Uncorrected (UCVA) and DCVA in 4 m, 80 cm, 40 cm; contrast sensitivity (CS) under photopic and mesopic conditions; reading skills (Radner Reading Charts); defocus curve, questionnaire on optical quality (OQ) and spectacle independence were assessed after 3 months.
Main Outcome Measures: At 3 months postoperatively, UCVA and DCVA in 4 m, 80 cm, 40 cm (logMAR); defocus curves; CS; reading skills; and OQ questionnaire results.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Implantation of multifocal intraocular lens
Procedure/Surgery:
Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery.
Eligibility Criteria
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Inclusion Criteria
* age \> 45 years
* corneal astigmatism ≤ 0.75 D postoperatively
* pupil size 3 to 6 mm (mesopic)
* center shift \< 1 mm
Exclusion Criteria
* amblyopia
* potential postoperative distance-corrected visual acuity (DCVA) \< 0.3 logMAR
45 Years
ALL
Yes
Sponsors
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Oculentis GmbH
UNKNOWN
University Clinic Frankfurt
OTHER
Responsible Party
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Myriam Böhm, MD
Professor Dr. med. Thomas Kohnen
Principal Investigators
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Thomas Kohnen, Professor
Role: PRINCIPAL_INVESTIGATOR
Goethe University Clinic Frankfurt
Locations
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Department of ophthalmology University clinic Frankfurt
Frankfurt am Main, Hesse, Germany
Countries
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Other Identifiers
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153/14
Identifier Type: -
Identifier Source: org_study_id
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