LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Astigmatism
- Myopia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Phase I Successful unilateral treatment of the dominant eye according to standard of care prior to investigational treatment Unilateral investigational treatment on an amblyopic eye or a post-cataract eye 4 eyes & 4 participants Staged patient enrolment, to allow assessment and evaluation of safety parameters before investigational treatment is applied to the next participant Interim analysis I - Verification of correction factor when all participants have reached 7 days follow-up Phase II Initiated after Interim analysis I Successful unilateral treatment of the dominant eye according to standard of care prior to investigational treatment Unilateral investigational treatment on the non-dominant eye 10 eyes & 10 participants Interim analysis II - Confirmation of correction factor when all participants have reached 7 days follow-up Phase III Initiated after Interim analysis II Bilateral investigational treatment 26 eyes & 13 participants Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04794023
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon