N/A
Completed N=30
Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Source: ClinicalTrials.gov NCT02575911 ↗Enrolled (actual)
30
Serious AEs
0.8%
Results posted
May 2017
Primary outcomePrimary: Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative — 125.8 micrometers
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flap Thickness Accuracy Within the Central Zone at Month 3 Postoperative |
125.8 | — |
| SECONDARY Flap Thickness Accuracy Within the Central Zone at Month 1 Postoperative |
127.8 | — |
| SECONDARY Flap Thickness Precision Within the Central Zone at Month 1 and Month 3 Postoperative |
127.8; 125.8 | — |
| SECONDARY Ease of Flap Dissection at Day 0, Operative Day |
4.7 | — |
| SECONDARY Stromal Bed Quality at Day 0, Operative Day |
5.0 | — |
| SECONDARY Opaque Bubble Layer (OBL) at Day 0, Operative Day |
0.3 | — |
| SECONDARY Uncorrected Distance Visual Acuity (UCDVA) at Month 1 and Month 3 Postoperative |
0.0; 0.0; 81.0; 84.5; 8.6; 6.9 | — |
| SECONDARY Best Corrected Distance Visual Acuity (BCDVA) by Visit |
0.0; 1.7; 0.0; 91.7; 91.4; 98.3 | — |
| SECONDARY Manifest Refraction Spherical Equivalent (MRSE) |
-2.846; -0.194; -0.166 | — |
| SECONDARY Prediction Error Between Target Versus Achieved Refraction at One and Three Months Post-op |
93.1; 91.4; 98.3; 100.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02575911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.