NCT06922084招募中4 期
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
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Binocular photopic CDVA (corrected distance visual acuity)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bilateral Clareon PanOptix IOL implantation
Active Comparator
干预措施: Clareon PanOptix (Device)
Bilateral Clareon PanOptix Pro IOL implantation
Experimental
干预措施: Clareon PanOptix PRO (Drug)
Clareon PanOptix Pro in the non-dominant eye and Clareon Vivity in the dominant eye
Experimental
干预措施: Mix-and-Match PanOptix/Vivity (Drug)
结局指标
主要结局
Binocular photopic CDVA (corrected distance visual acuity)
时间窗: 3 months postoperatively
次要结局
- Binocular photopic DCIVA (distance corrected intermediate visual acuity) and DCNVA (distance corrected near visual acuity)(3 months postoperatively)
- Binocular photopic small letter contrast sensitivity at 66 cm and 100 cm with refractive distance correction (20/32 line)(3 months postoperatively)
- Binocular mesopic high contrast distance corrected visual acuity at distance (CDVA), intermediate (DCIVA), and near (DCNVA).(3 months postoperatively)
- Refractive outcomes(3 months postoperatively)
- Pupil size(3 months postoperatively)
- Patient-reported outcomes using a questionnaire about visual disturbances (QUVID)(3 months postoperatively)
- Patient-reported outcomes using a questionnaire about IOL satisfaction (IOLSAT)(3 months postoperatively)
- Binocular photopic uncorrected visual acuity at distance (UDVA), intermediate (UIVA), and near (UNVA)(3 months postoperatively)
- Binocular photopic distance corrected defocus curve(3 months postoperatively)
- Monocular photopic distance corrected defocus curves(3 months postoperatively)
- Binocular mesopic distance corrected contrast sensitivity with and without glare (1.5, 3, 6 & 12 cpd)(3 months postoperatively)
研究者
研究点 (2)
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