Clareon Intraocular Lens Stability in Vitrectomy Patients: CLOVE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Position stability of Clareon and Tecnis 1 IOL
研究概览
简要总结
This prospective randomized controlled trial will be conducted to investigate Clareon intraocular lens (IOL) stability in vitrectomy patients. The investigator plans to target the patients undergoing cataract surgery. A randomized study will be conducted with 2 arms, one with Clareon IOL versus a second arm using the Tecnis 1 In this non-inferiority study, the investigator will compare Clareon IOL from Alcon with the existing Tecnis 1 IOL from Precision Lens which is the commonly used intraocular lens in combined vitrectomy cases in Hong Kong.
详细描述
All patients will undergo standard phacoemulsification cataract extraction with Clareon IOL or Tecnis 1 IOL by an experienced cataract surgeon. Followed by vitrectomy to treat either, epiretinal membrane or vitreous hemorrhage.
All patients returned for follow-up visits at 1 week, 1 month, and 6 months after surgery for ophthalmic assessments including:
- Visual acuity measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
- Refraction
- Axial movement and tilt measured by Pentacam (OCULUS Optikgeräte GmbH, Germany) using the Sasaki method. The Scheimpflug image of the horizontal cross-section and the vertical cross-section of the IOL will be selected for measurement. Central ACD will be measured as the distance between the central corneal posterior endothelium to the anterior surface of IOL. The subtraction in ACD between two visits indicated forward or backward axial movement of the IOL.
- Decentration will be measured from the center of the IOL anterior surface to the pupillary axis, which will be perpendicular to the line between the two anterior chamber angles and through the midpoint of the line.
- Tilt will be measured as the angle between the IOL axis and the perpendicular visual axis.
- Any surgical complications and post-op complications will be documented.
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 (Participant)
盲法说明
Patients are randomised and masked from the treatment
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of senile cataracts and epiretinal membranes or vitreous hemorrhage
- •Age between 50 and 80 years.
排除标准
- •Diagnosis of vision-impairing diseases including uveitis, glaucoma and corneal pathologies resulting in high astigmatism, severe refractive error (preoperative spherical equivalent of either eye >-6.00D or +5.00D);
- •Diagnosis of possible lenses instability including History of ocular trauma, Pseudoexfoliation syndrome; past refractive surgery or other ophthalmic surgery;
- •Known Capsular or zonular disorders that might affect the post-operative centration of IOLs, e.g., pseudo-exfoliation syndrome or Marfan syndrome;
- •Surgical complications including severe hyphema, iris injury, repeated IOL implantation during surgery, failure to achieve in-the-bag IOL implantation, posterior capsular rupture, usage of tamponade (gas or oil) and corneal sutures.
- •Difficulty in obtaining IOL measurements (eg. Small pupil, corneal opacities, patient cooperation)
结局指标
主要结局
Position stability of Clareon and Tecnis 1 IOL
时间窗: 1 week, 1 month and 6 months
Two arms will compare Intraocular lens stability, which will be measured by it's tilt, measures in degrees from iris plane (0, deg). Tilt will be measured using Pentacam by Sasaki method.
次要结局
- Axial movement(1 week, 1 month and 6 months)
- Decentration(1 week, 1 month and 6 months)
- Refraction(1 week, 1 month and 6 months)
- Compare intra operative and post operative complication(1 week, 1 month and 6 months)
- Visual acuity(1 week, 1 month and 6 months)
研究者
Dr. Nicholas Fung
Clinical Asst Professor
The University of Hong Kong