Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation
NCT ID: NCT02826421
Last Updated: 2018-07-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2016-07-04
2016-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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UltraSert Preloaded Delivery System
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
UltraSert Preloaded Delivery System
Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
iTec Preloaded Delivery System
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
iTec Preloaded Delivery System
Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
iSert Preloaded Delivery System
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
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
Monarch III D Manual IOL Delivery System
Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
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
Interventions
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UltraSert Preloaded Delivery System
Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
iTec Preloaded Delivery System
Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
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
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
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* 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;
22 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Manager, GCRA
Role: STUDY_DIRECTOR
Alcon Research
Other Identifiers
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ILN296-P001
Identifier Type: -
Identifier Source: org_study_id
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