[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07084844":3,"trial-entities:NCT07084844":99,"trial-summary:NCT07084844":102},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":36,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":72,"locations":74,"central_contacts":93,"overall_officials":95,"references":97,"see_also_links":98},"NCT07084844","PB-25-02","Patient Reported Outcomes With WaveLight Plus LASIK","Patient Reported Outcomes and Satisfaction With Wavelight Plus LASIK","RECRUITING","2026-09-01","2025-09","2025-09-15","2025-09-05","Mann Eye Institute","OTHER",false,"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.",null,[19,20],"Myopia","Astigmatism",[],"OBSERVATIONAL",[],{"count":25,"type":26},52,"ESTIMATED",[28],{"type":29,"name":30,"description":31},"DEVICE","WaveLigh 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.",[33],{"measure":34,"timeFrame":35},"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",[37,40,43],{"measure":38,"description":39,"timeFrame":35},"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).",{"measure":41,"description":42,"timeFrame":35},"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.",{"measure":44,"description":45,"timeFrame":35},"Uncorrected distance visual acuity","% of eyes in each level of uncorrected visual acuity (e.g. 20\u002F20, 20\u002F16, 20\u002F12.5, 20\u002F10 with logMAR chart).","ALL","18 Years","39 Years",{"inclusion":50,"exclusion":64,"raw_text":71},[51,52,53,54,55,56,57,58,59,60,61,62,63],"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\u002F20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm",[65,66,67,68,69,70],"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","Inclusion Criteria:\n\n* Between the ages of 18 and 39\n* Meet the standard care requirements for LASIK\n* Spherical equivalent (SE) more than -1.00D and up to -9.00 diopters\n* Myopia ≤ -8.00 sphere (in minus cylinder format) and up to -3.00D astigmatism\n* SE difference between the manifest refraction and the Sightmap measured SE being less than 0.75D\n* Minimum residual stromal bed thickness of 250 µm\n* If currently wearing contact lenses:\n\n  * Soft CTL wearers discontinue for minimum 3 days\n  * RGP CTL wearers discontinue for 1 month per decade of wear\n* Stable refraction (2 consecutive manifest refractions within 0.25 SE)\n* Stable K readings (2 consecutive K readings in 2 consecutive visits)\n* Willing and able to complete all post-operative visits\n* Pre-surgery BCDVA of 20\u002F20 (0.00 logMAR) or better in each eye.Mesopic pupil size ≥ 4.5mm\n\nExclusion Criteria:\n\n* Subjects with any prior ocular surgery\n* Subjects with topographic evidence of keratoconus, or ectasia\n* Subjects with autoimmune diseases\n* Subjects who are pregnant or nursing\n* Systemic disease likely to affect wound healing, such as diabetes and severe atopy\n* Any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery",[73],"ADULT",[75],{"facility":13,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":90},"Houston","Texas","77004","United States",[81,87],{"name":82,"role":83,"phone":84,"phoneExt":85,"email":86},"Study Coordinator","CONTACT","713-580-2500","2389","Melissa.Wright@manneye.com",{"name":88,"role":89},"Phillip Brunson","PRINCIPAL_INVESTIGATOR",{"lat":91,"lon":92},29.76328,-95.36327,[94],{"name":82,"role":83,"phone":84,"phoneExt":85,"email":86},[96],{"name":88,"affiliation":13,"role":89},[],[],{"nct_id":4,"conditions":100,"biomarkers":101},[20,19],[],{"nct_id":4,"found":103,"summary":104,"prompt_version":114},true,{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an observational study, meaning researchers will watch and record information without giving specific treatments. It will involve 52 participants at one location.","completed","WaveLight Plus LASIK for Myopia and Astigmatism","This study is looking at how satisfied people are with their vision after having WaveLight Plus LASIK surgery. WaveLight Plus LASIK is a type of laser eye surgery that uses advanced technology to create a personalized treatment plan for each person. The study wants to see how satisfied you are with your uncorrected vision (vision without glasses or contacts) three months after the surgery. You might be able to join if you are between 18 and 39 years old, have myopia (nearsightedness) and\u002For astigmatism (blurry vision at all distances), and meet other standard requirements for LASIK. The study is currently unclear on its recruitment status.","Participants will be assessed up to 3 months after their surgery.",105,"You will have WaveLight Plus LASIK surgery and then be assessed up to 3 months afterward. This will include checking your vision and answering questionnaires about your satisfaction and quality of life.","Not stated in the trial record.",[],"v2"]