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Completed

NCT Number: NCT02826421

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

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).

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UltraSert Preloaded Delivery System

Device

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

iTec Preloaded Delivery System

Device

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

iSert Preloaded Delivery System

Device

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

Monarch III D Manual IOL Delivery System

Device

Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject

Primary outcomes

  1. Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)

    Time frame: 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 outcomes

  1. Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2016
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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