Mann Eye Institute
Houston, Texas, 77004, United States
Location status: Recruiting
NCT Number: NCT07084844
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.
Interested in participating?
Request Info18 year–39 year
All sexes
Observational
Houston, Texas, 77004, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months postoperative
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 3 months postoperative
Percentage of eyes with post-op spherical equivalent within +/- 0.25D, 0.50D, and 0.75D respectively.
Time frame: 3 months postoperative
Percentage of eyes with post-op cylinder within +/- 0.25D, 0.50D, and 0.75D respectively.
Contact information is provided by the study sponsor or research team.
Mann Eye Institute
Other
Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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