Manual Small Incision Cataract Surgery Outcomes in an Educational Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Manual Small Incision Cataract Surgery with outcomes of 20/40 or better at the end of a year and with spectacle correction
研究概览
简要总结
The overall objective is to determine the visual outcomes and cost to perform Manual Small Incision Cataract Surgery (MSICS) in a small cohort at an academic medical center in the United States. The primary outcome measure will be the percentage of the study group achieving a post operative visual acuity 20/40 Snellen. This percentage will be compared to historical cohorts reported for phacoemulsification cataract surgery (PCS), when performed in academic centers. A secondary outcome will be to determine the actual institutional cost of providing MSICS in the setting of an academic medical center. The hypothesis is that MSICS is appropriate for a teaching environment (as evidenced by a comparable rate of 20/40 acuity or better at 90 days post op, as compared to PCS), and can be provided at a cost that makes visual rehabilitation affordable to the uninsured and underinsured.
详细描述
The investigator will perform a study of a pilot implementation of portions of the Aravind method of promoting access to care and provision of surgical services in the setting of an academic medical center teaching program. Target enrollment is 100 subjects having cataracts. Potential subjects will be identified through vision screening programs and if cataracts are found they will be offered MSICS at a price deemed to be affordable by individuals without insurance.
A survey of Pima County providers found that $3500 was the lowest price offered to a self-pay patient for one-stage cataract extraction (CPT 66984) for PCS facility fee, surgeon fee, and anesthesia fee. The expectation is that MSICS can be delivered in a teaching environment at a cost of $500. The investigator wishes to determine if this price point is sustainable and if a continuing model of cataract visual rehabilitation service delivery can be safely, affordably, and ethically delivered to those who cannot afford to pay, while integrating resident education and autonomy into the delivery model.
The proposed outcome measure is the proportion of eyes that see 20/40 or better while wearing glasses for those participants that do not have comorbid conditions.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or older (adults).
- •Medically Stable, able to safely undergo surgery.
- •Nuclear sclerotic cataract
- •Preoperative best corrected visual acuity (BCVA) 20/80 or worse
- •Expected post-operative potential acuity of 20/40 or better
- •Able to pay the $500 cost of surgery at the time of surgery
排除标准
- •Potential subjects not satisfying any of the above
结局指标
主要结局
Manual Small Incision Cataract Surgery with outcomes of 20/40 or better at the end of a year and with spectacle correction
时间窗: 2 years
Post-cataract surgery the subject must have a visual acuity of 20/40 or better with spectacle correction
次要结局
未报告次要终点
研究者
Joseph Miller
Joseph Miller, MD, MPH
University of Arizona