Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
Study Overview
Brief Summary
The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
- •Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
- •If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
- •Willing and able to return for ALL scheduled follow-up examinations;
- •Willing and able to provide written informed consent;
- •Eligible for bilateral LASIK procedures to be done on the same day;
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
- •Known sensitivity to planned study concomitant medications;
- •Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
- •Irregular astigmatism, based on the Investigator's judgement;
- •Pregnant, lactating or planning to become pregnant during the course of the study;
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
LenSx
LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Intervention: Femtosecond Laser System (Device)
LenSx
LASIK surgery in both eyes using LenSx® Femtosecond Laser System
Intervention: LASIK surgery (Procedure)
Outcomes
Primary Outcomes
Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative
Time Frame: Month 3 postoperative
Flap thickness was assessed by optical coherence tomography (OCT) and averaged from 3 separate scans. Flap thickness accuracy was defined as the mean difference between the achieved and desired (desired subtracted from achieved) flap thickness. A positive number represents a postoperative flap thickness that is thicker than the expected flap thickness and vice versa for a negative number. Each eye contributed separately to the analysis.
Secondary Outcomes
- Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op(Month 1, Month 3 postoperative)
- Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative(Month 1, Month 3 postoperative)
- Ease of Flap Dissection at Day 0, Operative Day(Day 0, operative day)
- Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative(Month 1, Month 3 postoperative)
- Stromal Bed Quality at Day 0, Operative Day(Day 0, operative day)
- Opaque Bubble Layer (OBL) at Day 0, Operative Day(Day 0, operative day)
- Best Corrected Distance Visual Acuity (BCDVA) by Visit(Baseline, Month 1, Month 3 postoperative)
- Manifest Refraction Spherical Equivalent (MRSE)(Baseline, Month 1, Month 3 postoperative)
- Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative(Month 1 postoperative)