A Prospective, Randomized, Subject and Vision-assessor Masked, Multicenter Study Comparing Bilateral Clareon PanOptix, Bilateral Clareon PanOptix Pro, and Mixed Clareon PanOptix Pro/Vivity Intraocular Lens Implantation in Cataract Subjects

Обзор

Prospective, randomized, multicenter, multi-arm, subject and vision-assessor-masked, two stage study with Stage 1 as a three-arm initial enrollment period, followed by Stage 2 as a head-to-head study refined based on the Stage 1 data.

Вмешательства

• Устройство Clareon PanOptix
  Bilateral Clareon PanOptix IOL implantation
• Препарат Clareon PanOptix PRO
  Bilateral Clareon PanOptix PRO IOL implantation
• Препарат Mix-and-Match PanOptix/Vivity
  Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye

Первичные конечные точки

• Binocular photopic CDVA (corrected distance visual acuity) [Срок оценки: 3 months postoperatively]

Вторичные конечные точки (11)

• Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity) [Срок оценки: 3 months postoperatively]
• Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA) [Срок оценки: 3 months postoperatively]
• Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line) [Срок оценки: 3 months postoperatively]
• Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA). [Срок оценки: 3 months postoperatively]
• Binocular photopic distance corrected defocus curve [Срок оценки: 3 months postoperatively]
• Monocular photopic distance corrected defocus curves [Срок оценки: 3 months postoperatively]
• Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd) [Срок оценки: 3 months postoperatively]
• Refractive outcomes [Срок оценки: 3 months postoperatively]
• Pupil size [Срок оценки: 3 months postoperatively]
• Patient-reported outcomes using a questionnaire about visual disturbances (QUVID) [Срок оценки: 3 months postoperatively]
• Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT) [Срок оценки: 3 months postoperatively]

Критерии участия

Критерии включения

• Adult cataract patients aged 40 years and older scheduled for age related cataract surgery in both eyes.
• Ability to understand and sign an ethics committee-approved informed consent form.
• Willingness and ability to attend all scheduled study visits as required by the protocol.
• Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
• Preoperative corneal astigmatism that can be corrected with a T3 or T4 toric IOL, or with a spherical IOL and LRIs or AKs resulting in a predicted postoperative astigmatism of less than 0.5 diopters (D).
• Ability to understand and complete questionnaires.

Критерии исключения

• Women who are pregnant, planning to become pregnant during the study, or breastfeeding.
• Ocular conditions that could confound study results, including moderate to severe corneal pathology, irregular astigmatism, moderate to severe dry eye, preexisting retinal diseases such as macular degeneration or diabetic retinopathy.
• Any form of confirmed glaucomatous damage (ie, mild, moderate, or severe glaucoma).
• Participation in another clinical study that could interfere with the results.
• Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders).
• Subjects with nystagmus, strabismus, zonular laxity or dehiscence, and pseudoexfoliation.
• Prior ocular surgery (except for uncomplicated cataract surgery in the fellow eye).
• Participants desiring monovision.
• Any active ocular infection or inflammation (except for routine post-operative inflammation in the fellow eye)
• Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide accurate self-assessments.
• RMS total higher-order aberrations (HOAs) >0.70 µm or coma >0.40 µm as measured by tomography or topography with a 4 mm pupil setting.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Shafer Vision Institute — Plymouth Meeting
• Berkeley Eye Center — Houston

Идентификаторы

NCT: NCT06922084 · 95474481

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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