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CompletedNCT04274088Updated Feb 21, 2020

The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.

An observational study in IOL, Cataract, sponsored by Hospital Hietzing. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-21.

Sponsored by Hospital Hietzing · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
65
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • IOL, Cataract

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Keywords

  • multifocal IOL, optical quality, angle alpha
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

patients of the clinic

Inclusion criteria

  • corneal astigmatism less than 1 diopter

Exclusion criteria

Exclusion Criteria:

  • ocular pathology others than cataract
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
65 participants (actual)
Patient registry
No

Groups and cohorts

  • Tecnis;

    Patients who received the Tecnis multifocal IOL.

    Procedure: Cataract surgery

  • Diffractiva

    Patients who received the Diffractiva multifocal IOL.

    Procedure: Cataract surgery

Interventions

  • ProcedureCataract surgery

    Phacoemulsification surgery

05

What researchers measure

Primary outcomes

  1. Visual Acuity

    Schnellen VA

    Time frame: 6 Month

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 33471202 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04274088
Lead sponsor
Hospital Hietzing
Responsible party
Kata Mihaltz (Chief Resident, MD, PhD, Hospital Hietzing) — Principal investigator
First posted
Feb 18, 2020
Start date
Oct 2014
Primary completion
Oct 2016
Completion
Oct 2018
Last update
Feb 21, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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