The Clinical Importance of Angle Alpha by Multifocal Intraocular Lenses.

Completed

• Conditions: IOL, Cataract
• Interventions: Procedure: Cataract surgery

• Registration Number: NCT04274088
• Lead Sponsor: Hospital Hietzing

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2016-10
• Study Completion: 2018-10
• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-18
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• corneal astigmatism less than 1 diopter

Exclusion Criteria

• ocular pathology others than cataract

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tecnis;	Cataract surgery	Patients who received the Tecnis multifocal IOL.
Diffractiva	Cataract surgery	Patients who received the Diffractiva multifocal IOL.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	6 Month	Schnellen VA