Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 7/4/2018 |
Start Date: | October 28, 2015 |
End Date: | April 9, 2016 |
The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ
keratomileusis (LASIK) flaps created with the LenSx® Laser.
keratomileusis (LASIK) flaps created with the LenSx® Laser.
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.
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