Health TrialsbyHealthPanel

SMILE Surgery in One Eye Compared to Ray Tracing-guided LASIK Surgery in the Fellow Eye

ConditionsMyopiaAstigmatism
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22-59
SponsorStanford University

About this trial

Participants will undergo LASIK surgery in one eye using ray tracing guided technology in one eye and LASIK surgery in the other eye using wavefront guided technology. We are comparing outcomes between the two technologies as measured by self reported quality of vision and quality of life outcomes using validated questionnaires before and after surgery. We will also be comparing outcomes between the two technologies including measurement of low contrast visual acuity,and best spectacle corrected visual acuity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Ray tracing guided LASIK surgery

    Device

    LASIK

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Ray tracing guided LASIK surgeryActive comparator 1 intervention
Group B: SMILE surgeryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in corrected distance visual acuity

The primary endpoint will be the gain in lines of corrected distance visual acuity (CDVA) at the postoperative month three follow-up compared with preoperative baseline.

Time frame
Three months

Secondary outcomes

1

Change in 5 and 25% low contrast CDVA

Change in 5 and 25% low contrast best corrected visual acuity from preoperative to postoperative month three

Time frame
Three months
2

Change in patient self reported quality of vision and life

Will compare preoperative quality of vision and quality of life as measured by the validated Patient Reported Outcomes With LASIK (PROWL) questionnaire to postoperative month three.

Time frame
Three months
3

Corneal epithelial thickness changes

Measure corneal epithelial thickness maps preoperatively and compare changes at postoperative month three

Time frame
Three months
4

Change in higher order aberrations

Will measure preoperative higher order aberrations using wavefront aberrometry and compare to postoperative month three measurements

Time frame
Three months

Other outcomes

Sponsors and contacts

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

Stanford University

Lead sponsor

Source ClinicalTrials.gov
Apply now