The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.

NCT ID: NCT04274088

Last Updated: 2020-02-21

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

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-10-31

Brief Summary

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Purpose: to evaluate the effect of visual axis positioning on the optical performance of the Tecnis MIOL and the Diff-aA MIOL.

Detailed Description

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In this prospective, randomized comparative study 70 eyes of 35 subjects with senile cataract were implanted with the spherical aberration correcting diffractive, bifocal Tecnis ZLB00 IOL, and 60 eyes of 30 age matched subjects with the spherical aberration neutral, diffractive, bifocal Diffractiva IOL. Observation Procedure was performed 1, 3, 6 months postoperatively. Main Outcome Measures included uncorrected and corrected distance and near visual acuity, manifest refraction, ocular aberrations and visual quality metrics with 2mm and 4mm pupil, and the position of visual axis.

Conditions

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IOL, Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tecnis;

Patients who received the Tecnis multifocal IOL.

Cataract surgery

Intervention Type PROCEDURE

Phacoemulsification surgery

Diffractiva

Patients who received the Diffractiva multifocal IOL.

Cataract surgery

Intervention Type PROCEDURE

Phacoemulsification surgery

Interventions

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Cataract surgery

Phacoemulsification surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* corneal astigmatism less than 1 diopter

Exclusion Criteria

* ocular pathology others than cataract
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Hietzing

OTHER

Sponsor Role lead

Responsible Party

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Kata Mihaltz

Chief Resident, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Mihaltz K, Vecsei-Marlovits PV. The impact of visual axis position on the optical quality after implantation of multifocal intraocular lenses with different asphericity values. Graefes Arch Clin Exp Ophthalmol. 2021 Mar;259(3):673-683. doi: 10.1007/s00417-020-05052-5. Epub 2021 Jan 20.

Reference Type DERIVED
PMID: 33471202 (View on PubMed)

Other Identifiers

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HHietzing3

Identifier Type: -

Identifier Source: org_study_id

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