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

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ClinicalTrials.gov Identifier: NCT02826421
Recruitment Status : Completed
First Posted : July 11, 2016
Results First Posted : July 28, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Cataracts Device: UltraSert Preloaded Delivery System Device: iTec Preloaded Delivery System Device: iSert Preloaded Delivery System Device: Monarch III D Manual IOL Delivery System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device
Actual Study Start Date : July 4, 2016
Actual Primary Completion Date : November 29, 2016
Actual Study Completion Date : November 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826421


Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Sr. Clinical Manager, GCRA Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02826421     History of Changes
Other Study ID Numbers: ILN296-P001
First Posted: July 11, 2016    Key Record Dates
Results First Posted: July 28, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Alcon Research:
Intraocular lens

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases