A Randomized, pilot study, subject-masked comparison of visual function after bilateral implantation of Presbyopia-correcting IOLs

Phase 4

Completed

• Conditions: bilateral cataract; stare; 10047518

• Registration Number: NL-OMON34149
• Lead Sponsor: Alcon Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
* are willing and able to understand and sign an informed consent;
* * 1.00 Dioptres of corneal astigmatism in both eyes
* are willing and able to attend postoperative examinations per protocol schedule;
* are at least 21 years of age, of either gender and any race;
* require cataract extraction followed by posterior IOL implantation used as an on-label procedure;
* be willing to have second eye surgery within one month of first eye surgery; Note: The second eye surgery should not be performed less than one week (7 days) after the first eye surgery.
* are in good ocular health, with the exception of cataracts;
* are free of disease(s)/condition(s) listed in the *Caution* section of the AcrySof® ReSTOR® +3 and LENTIS® Mplus package inserts

Exclusion Criteria

* Planned multiple procedures, including LRI, during cataract/IOL implantation surgery
* Amblyopia
* Previous corneal surgery
* Clinically significant corneal endothelial dystrophy (e.g., Fuchs* dystrophy)
* History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
* Diabetic retinopathy
* Macular degeneration
* Subjects with pupil abnormalities (e.g., corectopia)
* History of retinal detachment
* Subjects that have an acute or chronic disease or illness that would increase the operative risk or confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness)
* suturing of incision required at time of surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Outcome parameter is unilateral uncorrected near visual acuity (40cm).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Exploratory outcome measurements include<br /><br><br /><br>- Unilateral uncorrected distance and uncorrected intermediate visual acuity<br /><br>- Bilateral uncorrected distance, near and intermediate vision<br /><br>- Contrast Sensitivity (unilateral and bilateral)<br /><br>Range of functional vision using binocular defocus curve with best distance<br /><br>correction<br /><br><br /><br>- Reading speed<br /><br><br /><br>Safety parameters include any adverse events during the course of the study.<br /><br>All adverse events and Alcon product related complaints will be collected at<br /><br>all study visits. The complete study plan is presented in table 18.1</p><br>