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

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The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ
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.
We found this trial at
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Fort Worth, TX
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