NCT05561478招募中不适用
Comparison of Visual Outcomes After Implantation of the Synthesis Plus and Synthesis Plus Toric
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- DCIVA at 66 cm
研究概览
简要总结
Prospective controlled monocentric study to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS IOL.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 50 years old
- •Patient requiring bilateral cataract surgery
- •Regular corneal astigmatism >0.5D measured by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS TORIC or Regular corneal astigmatism lower or equal to 0.5 D dioptres by MS-39 (SimK keratometry and regularity determined by the topography) for patients implanted with SYNTHESIS PLUS.
- •Expected postoperative astigmatism ≤ 0.75D diopter
- •Corneal astigmatism ≤4D
- •IOL spherical equivalent power requested between 15D and 25D
- •Signed informed consent
- •Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- •Non inclusion Criteria:
- •Patients with a potential postoperative visual acuity of less than 5/10, in particular due to degenerative visual disorders, poor retinal function or a damaged cornea.
- •Amblyopia with a visual acuity potential of less than 5/10
- •IOL power needed outside the spherical equivalent diopter range: 15 to 25D
- •Difficulty for cooperation (distance from their home, general health condition)
- •Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
- •Irregular astigmatism
- •Subject with postoperative astigmatism, expected > 0.75 D.
- •Any ocular comorbidity
- •History of ocular trauma or prior ocular surgery including refractive procedures
- •Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- •Patients with chronic uveitis
- •Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions, diameter (pupil>4mm or <2.5 mm in photopic conditions))
- •Narrow anterior chambers (ACD ≤ 2.5 mm)
- •Any corneal pathology potentially affecting the topography (eg. Keratoconus),
- •Monophthalma patients
- •Phacodonesis
- •Exclusion criteria:
- •Complicated surgery
- •Inability to place the intraocular lens safely at the location planned
- •Subjects with zonular laxity
- •Postoperative endophthalmitis
排除标准
- 未提供
结局指标
主要结局
DCIVA at 66 cm
时间窗: 1 month
The primary objective of this study is to determine the non-inferiority of the distance-corrected intermediate visual acuity at 66 cm of the SYNTHESIS PLUS TORIC with respect to the SYNTHESIS PLUS
次要结局
- Monocular BCDVA(1 month)
- Rotational stability(Peroperatively, day 0, Month 1)
- Monocular UIVA(1 month)
- Refraction(1 month)
- Monocular DCIVA(1 month)
- Monocular UDVA(1 month)
- Potential complications(1 month)
- Subjective quality of vision(1 month)
研究者
研究点 (1)
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