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

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Device: Monarch III D Manual IOL Delivery System; Device: iTec Preloaded Delivery System; Device: iSert Preloaded Delivery System; Device: UltraSert Preloaded Delivery System

• Registration Number: NCT02826421
• Lead Sponsor: Alcon Research

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-04
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-11
• Primary Completion: 2016-11-29
• Study Completion: 2016-11-29
• Results First Submitted: 2017-06-30
• Results First Submitted QC: 2017-06-30
• Status Verified: 2017-07
• Results First Posted: 2017-07-28
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monarch III D Manual IOL Delivery System	Monarch III D Manual IOL Delivery System	Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
iTec Preloaded Delivery System	iTec Preloaded Delivery System	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
iSert Preloaded Delivery System	iSert Preloaded Delivery System	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
UltraSert Preloaded Delivery System	UltraSert Preloaded Delivery System	Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

Primary Outcome Measures

Name	Time	Method
Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)	Day 0, operative day	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.

Secondary Outcome Measures

Name	Time	Method
Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)	Day 0, operative day	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.