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NCT04274088 Clinical Trial

The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.

IOL, Cataract Clinical Trial

Official title:
The Impact of Visual Axis Position on the Optical Quality After Implantation of Multifocal Intraocular Lenses With Different Asphericity Values

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04274088
Other study ID # HHietzing3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2014
Est. completion date October 2018

Study information
Verified date February 2020
Source Hospital Hietzing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date October 2018
Est. primary completion date October 2016
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- corneal astigmatism less than 1 diopter

Exclusion Criteria:

- ocular pathology others than cataract

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cataract surgery
Phacoemulsification surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Hietzing

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Acuity Schnellen VA 6 Month