Health TrialsbyHealthPanel

Contoura With Phorcides Compared to Wavefront Optimized LASIK

ConditionsMyopiaAstigmatism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-38
SponsorDaniel Terveen

About this trial

Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients at least age 21 years of age undergoing LASIK eye surgery

Willing and able to comprehend informed consent and complete 1 month post-op visit

Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

Candidates for Contoura with Phorcides (Myopic, astigmatism <3.0D)

Disqualifiers

Patients under 21 years of age

Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon

Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)

Pachymetry below 490

Trial design

Design model

Parallel

Treatments tested in this trial

  • Contoura with Phorcides

    Procedure/Surgery

    Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine

  • WaveLight Wavefront Optimized

    Device

    Participants that undergo LASIK surgery using WaveLight Wavefront Optimized

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Study: PhorcidesExperimental treatment 1 intervention
Group B: Control: Wavefront OptimizedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-Op UDVA

Percent of participants with monocular UDVA of 20/16 or better

Time frame
3 months post-op

Secondary outcomes

1

Post-OP BCVA

Percent of participants with monocular and binocular BCVA of 20/16 or better

Time frame
3 months post-op
2

Residual Refractive Error

Residual astigmatism and residual SE

Time frame
3 months post-op
3

Low Contrast Visual Acuity

25% low contrast visual acuity post-op

Time frame
3 months post-op
4

Pre-op and post-op visual acuity

Percent of participants with post-op UDVA equal to or better than their pre-op CDVA

Time frame
3 months post-op

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daniel Terveen

Lead sponsor

Vance Thompson Vision

Sponsor institution

Alcon Research

Collaborator

Source ClinicalTrials.gov
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