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
This trial does not accept healthy volunteersQualifiers
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 population
Eligible test subjects will be 18+ years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism. Patients who are eligible for LASIK surgery with the Wavelight Plus device may undergo the procedure even if they choose not to participate in the research study. The decision to perform surgery with the device will be made based on clinical indications, irrespective of participation in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wavelight Plus LASIK
DeviceWavelight plus LASIK is an advanced laser eye surgery technology designed to enhance visual outcomes through personalized treatment plans. This system integrates comprehensive diagnostics, including biometry, tomography, and wavefront measurements, to create a tailored ablation profile for each patient.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Wavelight Plus LASIK1 intervention
Trial outcomes
Primary outcomes
1
% of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)
Time frame
3 months postoperatively2
% of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in mesopic conditions at 3 months (monocular and binocular)
Time frame
3 months postoperatively3
% of eyes with CDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular)
Time frame
3 months postoperativelySecondary outcomes
1
% of eyes that achieve UDVA equal to or better than preoperative CDVA
Time frame
3 months postoperatively2
% of eyes with lines gained/lost lines (post-up UDVA VS pre-op CDVA)
Time frame
3 months postoperatively3
% of eyes with absolute MRSE within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months
Time frame
3 months postoperatively4
% of eyes that achieved manifest refraction cylinder within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months
Time frame
3 months postoperativelyOther outcomes
1
% of eyes with 10% contrast UDVA (mesopic, binocular) of 20/10, 20/12.5, 20/16, 20/20 and 20/25 at 3 months
Time frame
3 months postoperatively2
% of eyes with 10% contrast CDVA (mesopic, binocular) of 20/10, 20/12.5, 20/16, 20/20 and 20/25 at baseline and 3 months
Time frame
3 months postoperatively3
% of eyes with UDVA of 20/8 in photopic conditions at 3 months (monocular and binocular)
Time frame
3 months postoperatively4
% of eyes with CDVA of 20/8 in photopic conditions at 3 months (monocular and binocular)
Time frame
3 months postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Laser Defined Vision
Lead sponsor
Sengi
Collaborator
Source ClinicalTrials.gov