A prospective trial to assess effect of modified phakic IOL implantation in ameliorating Negative Dysphotopsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Resolution of Negative Dysphotopsia
研究概览
简要总结
Negative dysphotopsia is defined as symptom of seeing crescentic shadow by the patients after cataract surgery. There is no very effective treatment available for this.Trial is proposed to be conducted in patients complaining of negative dysphotopsia after cataract surgery. A modified phakic lens will be implanted in ciliary sulcus and resolution of symptoms of negative dysphotopsia will be evaluated. Investigator believes that this could turn out to be an effective and simple solution of Negative Dysphotopsia.
Results
Out of 10 patients, 2 were in prophylactic group and 8 in therapeutic group. All patients were relieved of symptoms or did not experience negative dysphotopsia. ( had total relief while one had partial resolution of symptoms. No serious adverse event occured. One patient had transient IOP rise subsiding with medical treatment and one had slight change in refractive status.
Conclusion
The device is very safe and effective for treatment and prophylaxis of negative dysphotopsia.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients complaining of Negative Dysphotopsia after cataract surgery.
排除标准
- •Patients not willing to undergo second intervention.
结局指标
主要结局
Resolution of Negative Dysphotopsia
时间窗: Day 1, 7, 30, 90
次要结局
- Adverse event(Day 0,1,7, 30, 90)