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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cataracts

Intervention / Treatment
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* Device: UltraSert Preloaded Delivery System
* Device: iTec Preloaded Delivery System
* Device: iSert Preloaded Delivery System
* Device: Monarch III D Manual IOL Delivery System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraocular lens