Trials / Terminated
TerminatedNCT02806726
Clinical Investigation iDesign System With 1.3-PRESBY Treatment and STAR S4 IR™ Excimer Laser System
A Prospective Study to Evaluate the Feasibility of a New Treatment Algorithm to Increase Depth of Focus After Wavefront-guided LASIK Correction of Myopic Refractive Errors With the iDesign System and Star S4 IR™ Excimer Laser System
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Abbott Medical Optics · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
A prospective study to evaluate the feasibility of a new treatment algorithm to increase depth of focus after wavefront-guided LASIK correction of myopic refractive errors with the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System. The purpose of this study is to determine whether wavefront-guided LASIK correction of myopic refractive errors with CustomVue combined with iDesign 1.3-PRESBY (presbyT-LASIK) treatments mitigate the effects of presbyopia by increasing the depth of focus compared to iDesign CustomVue treatments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | iDesign 1.3-PRESBY treatment | Software used to calculate the LASIK treatment profile including a presbyopic correction component for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System. |
| DEVICE | iDesign 1.3 treatment | Software used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System. |
Timeline
- Start date
- 2016-07-13
- Primary completion
- 2017-11-09
- Completion
- 2017-11-09
- First posted
- 2016-06-21
- Last updated
- 2025-02-04
- Results posted
- 2019-02-08
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02806726. Inclusion in this directory is not an endorsement.