Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation
NCT02826421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114
Last updated 2018-07-02
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).
Conditions
- Cataracts
Interventions
- 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
- DEVICE
-
iTec Preloaded Delivery System
Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
- 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
- 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
Sponsors & Collaborators
-
Alcon Research
lead INDUSTRY
Principal Investigators
-
Sr. Clinical Manager, GCRA · Alcon Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-04
- Primary Completion
- 2016-11-29
- Completion
- 2016-11-29
- FDA Device
- Yes
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