Health TrialsbyHealthPanel

Patient Reported Outcomes With WaveLight Plus LASIK

ConditionsMyopiaAstigmatism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-39
SponsorMann Eye Institute

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 the Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 18 and 39

Meet the standard care requirements for LASIK

Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters

Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism

Disqualifiers

Subjects with any prior ocular surgery

Subjects with topographic evidence of keratoconus, or ectasia

Subjects with autoimmune diseases

Subjects who are pregnant or nursing

Trial population

Eligible test subjects will be 18 to 39 years of age and who are candidates for Wavelight Plus LASIK to correct myopia or myopic astigmatism.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • WaveLigh Plus LASIK

    Device

    Wavelight 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only).

Time frame
3 months postoperative

Secondary outcomes

1

PROWL-SS Questionnaire

PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items).

Time frame
3 months postoperative
2

OSDI Score

The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.

Time frame
3 months postoperative
3

Uncorrected distance visual acuity

% of eyes in each level of uncorrected visual acuity (e.g. 20/20, 20/16, 20/12.5, 20/10 with logMAR chart).

Time frame
3 months postoperative

Other outcomes

1

Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire

QIRC can be used to measure the quality of life of people who require an optical correction (spectacles, contact lenses or refractive surgery). Subjects select one of 6 responses for each question (20 questions total). Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome.

Time frame
3 months postoperative
2

Manifest Refraction Spherical Equivalent

Percentage of eyes with post-op spherical equivalent within +/- 0.25D, 0.50D, and 0.75D respectively.

Time frame
3 months postoperative
3

Cylinder

Percentage of eyes with post-op cylinder within +/- 0.25D, 0.50D, and 0.75D respectively.

Time frame
3 months postoperative

Sponsors and contacts

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

Mann Eye Institute

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
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