Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device

The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: UltraSert Preloaded Delivery System; Device: iTec Preloaded Delivery System; Device: iSert Preloaded Delivery System; Device: Monarch III D Manual IOL Delivery System

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to comprehend and sign a statement of informed consent;
• Willing and able to complete all required postoperative visits;
• Cataract;
• Planned cataract removal by phacoemulsification;
• Calculated lens power from 18.0 through 27.0 D inclusive;
• Preoperative astigmatism <1.0D;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Systemic disease that affects the cornea;
• Any inflammation or edema of the cornea;
• Previous or planned refractive or corneal surgery during the subject's participation in the study;
• Previous corneal transplant;
• Previous retinal detachment;
• Pregnancy or lactation, current or planned, during the course of the study;
• Current participation in another investigational drug or device study that may confound the results of this investigation;
• Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UltraSert Preloaded Delivery System; Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Device: UltraSert Preloaded Delivery System; Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
Active Comparator: iTec Preloaded Delivery System; Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Device: iTec Preloaded Delivery System; Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
Active Comparator: iSert Preloaded Delivery System; Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery	Device: iSert Preloaded Delivery System; Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject
Active Comparator: Monarch III D Manual IOL Delivery System; Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery	Device: Monarch III D Manual IOL Delivery System; Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)	Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.	Day 0, operative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)	Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.	Day 0, operative day

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Manager, GCRA, Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2016
• Primary Completion (Actual): November 29, 2016
• Study Completion (Actual): November 29, 2016

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: July 5, 2016
• First Posted (Estimate): July 11, 2016

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ILN296-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes