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Идёт набор NCT07127757

Clinical Evaluation of WaveLight Plus LASIK

— Наблюдательное Myopia Astigmatism

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Wavelight Plus LASIK.
Кому может быть актуально
Состояния в реестре: Myopia, Astigmatism. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Clinical Evaluation of Visual Outcomes With the Wavelight Plus Excimer Laser in Normal and Dim Lighting

Обзор

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular) [Срок оценки: 3 months postoperatively]
  • % of eyes with UDVA of 20/10, 20/12.5, 20/16 and 20/20 in mesopic conditions at 3 months (monocular and binocular) [Срок оценки: 3 months postoperatively]
  • % of eyes with CDVA of 20/10, 20/12.5, 20/16 and 20/20 in photopic conditions at 3 months (monocular and binocular) [Срок оценки: 3 months postoperatively]
Вторичные конечные точки (5)
  • % of eyes that achieve UDVA equal to or better than preoperative CDVA [Срок оценки: 3 months postoperatively]
  • % of eyes with lines gained/lost lines (post-up UDVA VS pre-op CDVA) [Срок оценки: 3 months postoperatively]
  • % of eyes with absolute MRSE within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months [Срок оценки: 3 months postoperatively]
  • % of eyes that achieved manifest refraction cylinder within +/- 0.25, 0.50, 0.75, and 1.00D at 3 months [Срок оценки: 3 months postoperatively]
  • Patient-Reported Outcomes with the modified PROWL Questionnaire and Low Luminance Questionnaire (LLQ-32) at 3 months [Срок оценки: 3 months postoperatively]

Критерии участия

Критерии включения

  • 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 20/20-2 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

Критерии исключения

  • 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/or family history
  • Previous intraocular or corneal surgery
  • Predicted residual stromal bed thickness < 250 μm
  • Intended to have monovision treatment
  • Participation in other current clinical trials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Laser Defined Vision — Greensboro

Идентификаторы

NCT: NCT07127757 · KS-25-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗