The Incidence of Glistenings in the 2017 Generation of Hydrophobic Acrylic Lenses Manufactured by Alcon and Abbott Medical Optics
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Incidence and density (severity) of glistenings at 18-month follow-up visit
研究概览
简要总结
The purpose of this study is to seek academic/non-industry research funding support to independently investigate the incidence and density of lens glistenings in cataract patients who are implanted with the latest generations of intraocular lenses (IOL) manufactured by Alcon and AMO Medical Optics.
详细描述
Glistenings are tiny, clear sparkling, fluid-filled microvacuoles that form within a lens after it has been placed in the eye. Glistenings are seen in all lenses but certain lenses develop a higher number of glistenings than others. The effect of glistenings on patients' visual functioning is largely unknown.
The occurrence of glistenings is in part related to the manufacturing technique. In 2013, manufacturers have claimed that recent improvements in manufacturing process have reduced the occurrence of glistenings. There is a lack of independent evaluation of this claim. We would like to assess independently: 1) How frequently do glistenings occur in patients implanted with the 2015 generation lenses? 2) Is there a difference in glistening occurrence between lenses manufactured by Alcon and Abbott Medical Optics (AMO) - the two largest companies in eye care products?
Two-hundred and seventy-six patients will be randomly assigned to receive Alcon or AMO lenses for their cataract surgery at the Kensington Eye Institute (KEI). After surgery, patients will be instructed to return for follow-up visits at 1 month, 6 months, 12 months and 18 months to assess for the occurrence of glistenings. If glistenings are observed at an earlier follow-up visit (e.g., the 6 month visit), patients will still be instructed to come for future visits so that changes in the glistenings over time can be observed.
Project Time-line:
Months 1-8: Participants recruiting, surgical operations, follow-up visits. Months 9-24: follow-up visits, data entry, cleaning and analysis, early results presentation, manuscript preparation and final report.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients consulting 5 surgeons for cataract surgery in the surgeon's primary offices
- •Patients aged 18 years or older
- •Patients who signed the consent form
排除标准
- •Individuals who cannot understand English in either written or verbal form and do not have language assistance available (e.g. from family members, friends)
- •Patients with co-existing condition of corneal disease
- •Patients with co-existing condition of uveitis
- •Patients with co-existing condition of optic nerve disease
- •Patients with co-existing condition of macular disease
- •Patients with co-existing condition of diabetes
- •Patients with co-existing condition of severe glaucoma (i.e. C/D ratio >=0.9 AND the patient is on glaucoma treatment)
- •Patients with prior refractive surgery
- •Patients with complications of cataract surgery occurred during or after surgery
结局指标
主要结局
Incidence and density (severity) of glistenings at 18-month follow-up visit
时间窗: 18-month follow-up
To determine if glistenings develop, eyes are dilated and examined. Photographs of the IOLs will be taken with a slit lamp camera for documentation. These photographs will then be assessed for glistenings in two ways: first by trained ophthalmology staff, and second using the ImageJ software Glistenings will be counted and graded on a scale of 0 to 5+ as following: 0. No glistening 1. Less than 10 glistenings 2. 10 to 25 glistenings 3. 25 to 50 glistenings 4. 50 to 100 glistenings 5. Greater than 100 glistenings
次要结局
- Glare disability in eyes with glistenings at 18-month follow-up visit(18 month follow-up)
- Visual acuity in eyes with glistenings at 18-month follow-up visit(18 month follow-up)
- Contrast sensitivity in eyes with glistenings at 18-month follow-up visit(18 month follow-up)
- Contrast sensitivity and glare disability in eyes with glistenings at 12-month follow-up visit(12-month follow-up)
- Contrast sensitivity in eyes with glistenings at 6-month follow-up visit(6-month follow-up)
- Glare disability in eyes with glistenings at 6-month follow-up visit(6-month follow-up)
- Incidence of glistenings at 12-month follow-up visit(12-month follow-up)
- Visual acuity in eyes with glistenings at 12-month follow-up visit(12-month follow-up)
- Glare disability in eyes with glistenings at 12-month follow-up visit(12-month follow-up)
- Visual acuity in eyes with glistenings at 6-month follow-up visit(6-month follow-up)
- Incidence of glistenings at 6-month follow-up visit(6-month follow-up)
研究者
Yaping Jin
Associate Professor in Ophthalmic Epidemiology
University of Toronto