Visual Outcomes Following Implantation of Tecnis Symfony Opti-Blue EDOF IOL in Patients With Mild to Moderate Retinal Ocular Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Binocular uncorrected visual acuity at distance
研究概览
简要总结
Tecnis Symfony Optiblue EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL in patients with retinal comorbidities.
详细描述
Extended depth of focus (EDOF) IOLs, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth of focus (DOF) and eliminate the overlapping of near and far images caused by traditional multifocal IOLs, thus generating a lower incidence of halos and glare. The Tecnis Symfony (Johnson & Johnson Vision) EDOF IOL incorporates a diffractive echelette design to increase the range of vision. The achromatic technology corrects chromatic aberration and increases retinal image contrast.
The latest version of the Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. As such, the present study aims to assess the visual outcomes at distance, intermediate and near following implantation of violet light filtering Tecnis Symfony Optiblue EDOF IOLs in patients with retinal comorbidities undergoing cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with retinal comorbidities, with visual acuity potential of 20/30 or better, who wish to undergo bilateral cataract surgery and are willing to provide written informed consent and adhere to study requirements.
排除标准
- •Corneal dystrophies
- •Central corneal scarring
- •Keratoconus
- •Proliferative diabetic retinopathy
- •Exudative macular degeneration
- •Zonular weakness
- •Pseudoexfoliation
- •Fovea-involving atrophy
- •Severe dry eye
- •Amblyopia
- •Pupil abnormalities
- •Need for an IOL outside the range of +5.0 D to +34.0 D or cylinder power over 3.75 D
- •Patients who have undergone prior cataract surgery and IOL implantation in either eye; had prior corneal refractive or corneal transplantation surgery; diabetics post-vitrectomy; or who have a history of macula-off retinal detachment will also be excluded.
结局指标
主要结局
Binocular uncorrected visual acuity at distance
时间窗: 3 months
Mean binocular uncorrected visual acuity at distance
Binocular uncorrected visual acuity at near
时间窗: 3 months
Mean binocular uncorrected visual acuity at near
Binocular uncorrected visual acuity at intermediate
时间窗: 3 months
Mean binocular uncorrected visual acuity at intermediate
次要结局
未报告次要终点