Anterior Chamber Versus Scleral Fixated Intraocular Lens: Long-term Vision and Safety Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Endothelial cell loss
研究概览
简要总结
This is a prospective comparative non-randomized cohort study to understand the long-term vision outcomes, safety, and stability of anterior chamber intraocular lenses (AC IOLs) vs. scleral-fixated intraocular lenses (SF IOLs).
详细描述
On the pre-operative visit, specular microscopy, biometry, applanation tonometry and ocular coherence tomography (OCT) will be performed. The patient will then undergo treatment as per surgeon's discussion/ decision with the patient for implantation of an AC-IOL or SF-IOL. Participation in the study will not impact the management plan in any way. Specular microscopy will be performed wit the CellChek XL (Konan Medical, Irvine, CA). Biometry will be performed with the IOLMASTER (Carl Ziess Meditec, Jena, Germany), and anterior segment and macular OCT will be performed with the Cirrus-HD OCT (Carl Zeiss Metidec, Jena, Germany). EC count, OCT (macula and anterior segment) and specular microscopy will be performed at baseline, week 1, month 1, month 6, 12 and 24.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are undergoing AC IOL or SF IOL implantation for any reason (including but not limited to aphakia, posterior capsular rupture, primary or secondary lens dislocation/ subluxation or IOL exchange).
- •Patients on whom imaging (specular microscopy, biometry and OCT) can be performed without delaying their treatment (i.e. based on availability of operator).
- •Decision makers able to provide informed consent.
排除标准
- •Inability to obtain adequate imaging, in the form of specular microscopy and OCT data at baseline.
- •Patients unable to attend follow-up visits.
- •Patients who have had a corneal transplant prior to secondary IOL implantation.
结局指标
主要结局
Endothelial cell loss
时间窗: Pre-operative (baseline) and 24 weeks post-operatively.
Change in endothelial cell count from baseline compared to 24 months post-operatively.
次要结局
- Corrected distance visual acuity (CDVA)(Pre-operative (baseline), week 1, months 1, 6, 12 and 24 post-operatively.)
研究者
Dr. Peter Kertes
Ophthalmologist - Retina Specialist
Sunnybrook Health Sciences Centre