A Prospective Study of Femtosecond Laser Intracorneal Lensectomi in Treatment of Moderate to High Myopia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Odense University Hospital
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Visual acuity
Study Overview
Brief Summary
The purpose of this study is to compare visual acuity, safety, predictability, corneal biomechanics, dry eyes, and nerve-morphology after all femtosecond laser refractive lenticule extraction. Approximately 30 to 40 patients with moderate to high myopia will randomly (after ocular dominance) receive ReLEx flex in one eye, and ReLEx smile in the other.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 25 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •25 to 45 years,
- •moderate to high myopia with astigmatism =< 2 D,
- •otherwise eye healthy,
- •CDVA of 0.8 or better (Snellen).
Exclusion Criteria
- •systemic or ocular disease or previous eye surgery,
- •thin cornea,
- •a difference of more than 2 D myopia in the eyes of each subject.
Arms & Interventions
Carl Zeiss Meditech VisuMax laser - ReLEx flex
>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
Intervention: Carl Zeiss Meditech VisuMax laser (Device)
Carl Zeiss Meditech VisuMax laser - ReLEx smile
>30 patients will receive treatment for myopia with a VisuMax femtosecond laser from Carl Zeiss. The laser can cut with two different settings, called ReLEx flex and ReLEx smile. One eye will recieve ReLEx flex, and the other ReLEx smile
Intervention: Carl Zeiss Meditech VisuMax laser (Device)
Outcomes
Primary Outcomes
Visual acuity
Time Frame: up to 6 months
Using ETDRS charts, both uncorrected and corrected distance visual acuity, along with visual acuity using the FrACT contrast chart
Secondary Outcomes
- refractive predictability(Pre-surgery, 1 week, 1 month, 3 months, 6 months)
Investigators
Anders H. Vestergaard
MD, PhD student
University of Southern Denmark