A randomized, subject-blinded evaluation of visual function after bilateral implantation of two types of presbyopia-correcting multifocal IOLs

Phase 4

Completed

• Conditions: bilateral cataract; presbyopia; 10047518

• Registration Number: NL-OMON37851
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

*Bilateral cataract
*Less than 1.00 diopters of corneal astigmatism in both eyes
*Fulfill the recommendations in the *Warnings* and *Precautions* sections of the AcrySof ReSTOR and FineVision package inserts*
*Age 42 years or older
*Expected postoperative logMAR +0.3 or better
*Availability to undergo second eye surgery within 2 weeks of the first eye surgery
*Willing and able to comply with scheduled visits and other study procedures
*Signed informed consent

Exclusion Criteria

*Planned multiple procedures, including LRI, during cataract/IOL implantation surgery
*Previous corneal surgery and/or reshaping
*Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy)
*History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
*Extensive age related macular degeneration (atrophic or exudative AMD or numerous soft drusen)
*Glaucoma related extensive visual field loss
*Extensive Diabetic macular disease
*Suturing of incision required at time of surgery
*Complications during surgery of the first eye.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure is the mean bilateral DCVA at intermediate distance<br /><br>(70cm) under mesopic conditions at 1, 3 and 6 months postoperatively. </p><br>