Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation
研究概览
简要总结
The purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP (Carl Zeiss Meditec AG) implantation to achieve satisfactory post-post-operativly spectacle-free vision. Social, biometric and patient reported outcomes will be evaluated.
详细描述
Pre-operatively all patients were submitted to a comprehensive ophthalmic history and examination including, corneal topography, and aberrometry (Pentacam), biometry (IOLMaster 700, Carl Zeiss Meditec AG, Jena, Germany), specular microscopy (CEM 539, Nidek Co Ltd.), and macular and papillary Optical Coherence Tomography (Cirrus 4000 Hd OCT, Carl Zeiss Meditec AG).
All surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag IOL placement. Patients had both eyes operated within a week.
Patients were assessed at day 1, 6, and month 3 after surgery. Six months post-operatively, refraction and slit-lamp examination was performed, and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction, spectacle independence and dysphoptsia like-symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 45 years old with clinical identified bilateral cataracts
- •Patients that want to have good vision most of the time without glasses at all distances
- •Highest limit of mesopic pupil of 6 mm
- •Corneal total higher-order aberration (HOA) ≤ 0.5 μm
- •Angle kappa ≤ 0.58 mm
- •Absence of cornea ectasia diagnostic criteria.
排除标准
- •Patients with moderate or severe dry eye syndrome
- •Ocular comorbidities such as corneal, retinal or optic nerve disease
- •Previous ocular surgeries
- •Patients with unreal post-surgical visual expectations
- •Patients with known mild cognitive impairment or dementia.
结局指标
主要结局
Correlation between macular ganglion cell thickness and contrast sensitivity in refractive cataract surgery patients - Identifying cutoff values that predict favourable mIOL adaptation
时间窗: December 2023
Evaluate if there is a correlation between macular ganglionar cell complex thickness and post-operative contrast-sensitivity at 6 months post-op
HOA detailed profile impact in dysphotopsia incidence after refractive cataract surgery - - Identifying cutoff values that predict favourable mIOL adaptation
时间窗: December 2023
Evaluate if specific HOA have a greater impact and association with dysphotopsias under the same IOL platform at 6 months post-op
次要结局
未报告次要终点
研究者
Guilherme Neri Pires
Principal Investigator
Hospital dos Lusíadas