[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07127757":3,"trial-entities:NCT07127757":110,"trial-summary:NCT07127757":113},{"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":33,"secondary_outcomes":41,"sex":52,"minimum_age":53,"maximum_age":17,"healthy_volunteers":17,"eligibility_criteria":54,"std_ages":82,"locations":85,"central_contacts":103,"overall_officials":106,"references":108,"see_also_links":109},"NCT07127757","KS-25-01","Clinical Evaluation of WaveLight Plus LASIK","Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting","RECRUITING","2026-09-01","2025-09","2025-10-02","2025-08-28","Laser Defined Vision","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 Low Luminance Questionnaire (LLQ-32) Questionnaire.",null,[19,20],"Myopia","Astigmatism",[],"OBSERVATIONAL",[],{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Wavelight 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.",[30],[34,37,39],{"measure":35,"timeFrame":36},"% of eyes with UDVA of 20\u002F10, 20\u002F12.5, 20\u002F16 and 20\u002F20 in photopic conditions at 3 months (monocular and binocular)","3 months postoperatively",{"measure":38,"timeFrame":36},"% of eyes with UDVA of 20\u002F10, 20\u002F12.5, 20\u002F16 and 20\u002F20 in mesopic conditions at 3 months (monocular and binocular)",{"measure":40,"timeFrame":36},"% of eyes with CDVA of 20\u002F10, 20\u002F12.5, 20\u002F16 and 20\u002F20 in photopic conditions at 3 months (monocular and binocular)",[42,44,46,48,50],{"measure":43,"timeFrame":36},"% of eyes that achieve UDVA equal to or better than preoperative CDVA",{"measure":45,"timeFrame":36},"% of eyes with lines gained\u002Flost lines (post-up UDVA VS pre-op CDVA)",{"measure":47,"timeFrame":36},"% of eyes with absolute MRSE within +\u002F- 0.25, 0.50, 0.75, and 1.00D at 3 months",{"measure":49,"timeFrame":36},"% of eyes that achieved manifest refraction cylinder within +\u002F- 0.25, 0.50, 0.75, and 1.00D at 3 months",{"measure":51,"timeFrame":36},"Patient-Reported Outcomes with the modified PROWL Questionnaire and Low Luminance Questionnaire (LLQ-32) at 3 months","ALL","18 Years",{"inclusion":55,"exclusion":67,"raw_text":81},[56,57,58,59,60,61,62,63,64,65,66],"Subject must be able to understand and sign an IRB approved Informed consent form","Willing and able to attend all scheduled study visits as required per protocol","Minimum of 18 years of age","Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction","Best corrected photopic distance visual acuity of 20\u002F20-2 or better (≤ 0.04 logMAR)","Mesopic pupil size ≥ 4.5mm","Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction","Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history","If currently wearing contact lenses:","Soft CTL wearers discontinue for minimum 3 days prior to first refraction","RGP or toric soft CTL wearers discontinue for ≥2 weeks prior to first refraction",[68,69,70,71,72,73,74,75,76,77,78,79,80],"Subjects who are pregnant or nursing","Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study","Patients with flap complications","Systemic medications that may confound the outcome of the study or increase the risk to the subject.","Ocular condition (other than high myopia) that may predispose the subject to future complications, such as ectasia","History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy)","Evidence of retinal vascular disease","Keratoconus or Keratoconus suspect","Glaucoma or glaucoma suspect by exam findings and\u002For family history","Previous intraocular or corneal surgery","Predicted residual stromal bed thickness \\\u003C 250 μm","Intended to have monovision treatment","Participation in other current clinical trials","Inclusion Criteria:\n\n* Subject must be able to understand and sign an IRB approved Informed consent form\n* Willing and able to attend all scheduled study visits as required per protocol\n* Minimum of 18 years of age\n* Myopia up to -8.00 D, astigmatism up to -3.00 D, with SE more than -1.00D and up to -9.00D, based on Sightmap measured refraction\n* Best corrected photopic distance visual acuity of 20\u002F20-2 or better (≤ 0.04 logMAR)\n* Mesopic pupil size ≥ 4.5mm\n* Less than 0.75 D manifest refraction spherical equivalent difference between Sightmap refraction and subjective manifest refraction\n* Stable refraction (within ± 0.50 D) as determined by manifest refraction spherical equivalent for a minimum of 12 months prior to surgery, verified by consecutive subjective refractions or medical records or prescription history\n* If currently wearing contact lenses:\n\n  * Soft CTL wearers discontinue for minimum 3 days prior to first refraction\n  * RGP or toric soft CTL wearers discontinue for ≥2 weeks prior to first refraction\n\nExclusion Criteria:\n\n* Subjects who are pregnant or nursing\n* Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study\n* Patients with flap complications\n* Systemic medications that may confound the outcome of the study or increase the risk to the subject.\n* Ocular condition (other than high myopia) that may predispose the subject to future complications, such as ectasia\n* History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy)\n* Evidence of retinal vascular disease\n* Keratoconus or Keratoconus suspect\n* Glaucoma or glaucoma suspect by exam findings and\u002For family history\n* Previous intraocular or corneal surgery\n* Predicted residual stromal bed thickness \\\u003C 250 μm\n* Intended to have monovision treatment\n* Participation in other current clinical trials",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":13,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":100},"Greensboro","North Carolina","27401","United States",[92,97],{"name":93,"role":94,"phone":95,"email":96},"Carrie Willams","CONTACT","336-288-8823","ldv2020@gmail.com",{"name":98,"role":99},"Karl Stonecipher, MD","PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},36.07264,-79.79198,[104],{"name":105,"role":94,"phone":95,"email":96},"Carrie Williams",[107],{"name":98,"affiliation":13,"role":99},[],[],{"nct_id":4,"conditions":111,"biomarkers":112},[20,19],[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an observational study involving 50 participants at a single location. It is a single-arm study, meaning everyone receives the WaveLight Plus LASIK intervention.","completed","Clinical Evaluation of WaveLight Plus LASIK for Myopia and Astigmatism","This study is looking at how well WaveLight Plus LASIK works for people with nearsightedness (myopia) and astigmatism (blurry vision due to an imperfectly shaped eye). WaveLight Plus LASIK is an advanced laser eye surgery that creates a personalized treatment plan for each person. Researchers want to see how satisfied people are with their vision, their quality of vision, and their quality of life after this surgery. They will measure how clearly people can see in different lighting conditions three months after surgery. You might be able to join if you are at least 18 years old and have myopia up to -8.00 D and astigmatism up to -3.00 D. The current recruitment status is unclear.","Participants will be assessed for up to 3 months after their surgery, with primary measurements taken at 3 months post-operatively.",116,"You would attend scheduled study visits and have clinical evaluations, including vision tests and questionnaires, for up to 3 months after surgery.","Not stated in the trial record.",[30],"v2"]