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

Alcon

Status: Completed

Conditions: Cataracts

Treatments: Device: iTec Preloaded Delivery System; Device: UltraSert Preloaded Delivery System; Device: iSert Preloaded Delivery System; Device: Monarch III D Manual IOL Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02826421

ILN296-P001

Details and patient eligibility

About

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).

Enrollment: 114 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 4 patient groups

UltraSert Preloaded Delivery System

Experimental group

Description:

Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

Treatment:

Device: UltraSert Preloaded Delivery System

iTec Preloaded Delivery System

Active Comparator group

Description:

Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

Treatment:

Device: iTec Preloaded Delivery System

iSert Preloaded Delivery System

Active Comparator group

Description:

Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery

Treatment:

Device: iSert Preloaded Delivery System

Monarch III D Manual IOL Delivery System

Active Comparator group

Description:

Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery

Treatment:

Device: Monarch III D Manual IOL Delivery System