SAS 1: Develop Ocular Disease (OSD) Diagnostic, Algorithms, and Management Protocols for Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
Patient: Tear film issues resulting in poor visual outcomes are a major cause of dissatisfaction after cataract surgery. There is no universal best preoperative algorithm for managing the ocular surface prior to surgery.
Industry: Recent advances in tear/cornea imaging and refractive cataract surgery such as multifocal intraocular lenses will be advantageous to patients only if tear film issues can be addressed.
Society: Cataract surgery is the most common ophthalmic surgery done in Singapore and worldwide. Improving vision by attending to tear film problems improves quality of life.
详细描述
Phase 1: Investigate the impact of ocular surface disease (OSD) on post-operative outcomes in cataract surgery.
Phase 1A: Longitudinal interventional parallel group study; small cohort to determine the impact of moderate dry eye for at-risk patient groups.
Phase 1B: Longitudinal interventional parallel group study; larger cohort of to compare outcomes based on different IOL types.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for dry eye (participant must meet at least 1 of the inclusion criteria below):
- •Symptomatic for dry eye based on DEQ5 (>6) and [either TBUT less than 5 s or staining >grade 1 in any zone of the cornea]
- •Either use of diquasfosol, cyclosporine eyedrops or tacrolimus eyedrops for dry eye disease in the last 2 weeks (and previously started for more than 2 months), OR current and visible lower punctal plugs in at least one eye
- •Inclusion criteria to fulfil all for controls (patients w/o dry eye):
- •Staining < grade 1 in at least one corneal zone.
- •Not using diquasfosol, cyclosporine, tacrolimus in last 2 months.
- •No visible punctal plugs.
排除标准
- •If there is another ocular condition which affects vision as much as cataract: active corneal stromal disease or scar or significant corneal endothelial disease
- •Known diagnosis of active thyroid dysfunction, Sjogren disease and rheumatoid arthritis
- •Intraocular surgery within the previous 6 months
- •Laser-assisted in situ keratomileusis or pterygium surgery within the previous 3 months
- •Central nervous system and hormonal drugs required within the last month and during the study
- •Active ocular infection, inflamed chalazion, or presence of pterygium
- •Glaucoma which requires topical anti-glaucoma medications
- •Any need to wear contact lens during the study
- •Having issues which make it difficult to follow up (eg., wheelchair, etc)
- •Pregnant and breast-feeding woman
结局指标
主要结局
Primary outcome
时间窗: From pre-op to Post Operative 3 to 6 weeks
Postoperative uncorrected visual acuity and repeatability of Biometry and Keratometry
次要结局
未报告次要终点
研究者
Louis Tong
Clinician-Scientist, Senior Consultant
Singapore National Eye Centre