Clinical Evaluation of WaveLight Plus LASIK
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaser Defined Vision
About this trial
This study is a single-site, single-arm, prospective, observational study of subject satisfaction, quality of vision, and quality of life after bilateral LASIK surgery. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the adapted PROWL and Low Luminance Questionnaire (LLQ-32) Questionnaire.
Eligibility criteria
Qualifiers
Subject must be able to understand and sign an IRB approved Informed consent form
Willing and able to attend all scheduled study visits as required per protocol
Minimum of 18 years of age
Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction
Disqualifiers
Subjects who are pregnant or nursing
Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study
Patients with flap complications
Systemic medications that may confound the outcome of the study or increase the risk to the subject.
Trial design
Treatments tested in this trial
- Wavelight Plus LASIK
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Laser Defined Vision
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov