Astigmatism, Myopia
Conditions
Brief summary
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.
Interventions
DEVICEWaveLigh Plus LASIK
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.
Sponsors
Sengi
Mann Eye Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* 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 * SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D * Minimum residual stromal bed thickness of 250 µm * If currently wearing contact lenses: * Soft CTL wearers discontinue for minimum 3 days * RGP CTL wearers discontinue for 1 month per decade of wear * Stable refraction (2 consecutive manifest refractions within 0.25 SE) * Stable K readings (2 consecutive K readings in 2 consecutive visits) * Willing and able to complete all post-operative visits * Pre-surgery BCDVA of 20/20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm
Exclusion criteria
* Subjects with any prior ocular surgery * Subjects with topographic evidence of keratoconus, or ectasia * Subjects with autoimmune diseases * Subjects who are pregnant or nursing * Systemic disease likely to affect wound healing, such as diabetes and severe atopy * Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean score of satisfaction with uncorrected vision after wavelight plus LASIK based on PROWL-SS Questionnaire preoperative vs postoperative (question #1 [Q1] only). | 3 months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROWL-SS Questionnaire | 3 months postoperative | 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). |
| OSDI Score | 3 months postoperative | 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. |
| Uncorrected distance visual acuity | 3 months postoperative | % of eyes in each level of uncorrected visual acuity (e.g. 20/20, 20/16, 20/12.5, 20/10 with logMAR chart). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Manifest Refraction Spherical Equivalent | 3 months postoperative | Percentage of eyes with post-op spherical equivalent within +/- 0.25D, 0.50D, and 0.75D respectively. |
| Cylinder | 3 months postoperative | Percentage of eyes with post-op cylinder within +/- 0.25D, 0.50D, and 0.75D respectively. |
| Quality-of-Life Impact of Refractive Correction (QIRC) Questionnaire | 3 months postoperative | 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. |
Countries
United States
Contacts
Primary ContactStudy Coordinator
Outcome results
None listed