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

Alcon Research114 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

114

Conditions

Cataracts

Interventions

UltraSert Preloaded Delivery SystemDEVICE

Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject

iTec Preloaded Delivery SystemDEVICE

Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject

iSert Preloaded Delivery SystemDEVICE

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

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Day 0, operative day

Secondary Outcomes

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.

Time frame: Day 0, operative day

Data from ClinicalTrials.gov

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