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| Sponsor: | Innovative Medical |
|---|---|
| Information provided by: | Innovative Medical |
| ClinicalTrials.gov Identifier: | NCT01061294 |
Purpose
The purpose of this study is to assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure (WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System). Patient data will be collected electronically and analyzed to determine improvements in postoperative visual acuity, visual quality and residual error.
| Condition | Intervention | Phase |
|---|---|---|
|
Vision Correction |
Procedure: Advanced CustomVue™ iLASIK procedure Device: WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Outcomes Using the AMO Advanced Customvue™ iLasik Procedure (Wavescan Wavefront® System, Star S4 IR™ Excimer Laser System and Intralse™ FS System) |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Advanced CustomVue™ iLASIK procedure | Procedure: Advanced CustomVue™ iLASIK procedure Device: WaveScan WaveFront® System, STAR S4 IR™ Excimer Laser System and IntraLase™ FS System |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | William Trattler, The Center for Excellence in Eye Care |
| ClinicalTrials.gov Identifier: | NCT01061294 History of Changes |
| Other Study ID Numbers: | iLASIK |
| Study First Received: | February 1, 2010 |
| Last Updated: | January 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Assess the efficacy, predictability and safety of the Advanced CustomVue™ iLASIK procedure. |