跳至主要内容
临床试验/NCT05614622
NCT05614622已完成不适用

The Effect of Mydriatics on Posterior Synechia After Combined Surgery of Pars Plana Vitrectomy, Phacoemulsification, and Intraocular Lens Implantation

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Number of participants developed iris posterior synechiae after surgery

研究概览

简要总结

The study goal is to evaluate the influence of mydriatic drops on the development of posterior synechia after combined cataract and vitrectomy surgery.

详细描述

Cataract and vitreoretinal disorders often coexist, and with up to 80 percent chance for cataract formation following vitreoretinal surgery within the first year, combined surgery of phacoemulsification, pars plana vitrectomy (PPV) and intraocular lens (IOL) implantation has become increasingly accepted.

The main advantages of combined surgery include better visualization during surgery and the elimination of the need for additional surgery, which translates to overall quicker visual recovery and cost-effectiveness. Like the more exercised, two-step procedure, the combined surgery was shown to be safe and effective with relatively few complications. However, one complication seen more frequently after the combined surgery is postoperative anterior chamber inflammatory response, and with it, the formation of posterior synechia, reaching an average of 18 percent.

The development of posterior synechia interferes with postoperative visualization of the fundus, thus diminishing an important advantage of the combined procedure. Moreover, in a few cases, it can even be complicated by angle closure glaucoma.

Currently, there is no consensus on whether postoperative treatment after combined surgery should include additional treatment to help prevent the formation of synechia. The frequency and severity of posterior synechia after a combined operation may be reduced using short-acting mydriatics. However, there is no sufficient data nor a prospective study to support this as common practice. It is, therefore, we sought to better evaluate the effect of topical short-acting mydriatics on the formation of posterior synechia after combined surgery and compare it with standard postoperative treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Patients who underwent combined cataract and vitrectomy surgery with IOL implantation.

排除标准

  • History of uveitis prior to surgery.

研究组 & 干预措施

Study

Experimental

The study group receives standard post-operative treatment same as the control group. And additional treatment of a short-acting mydriatic agent (Cyclopentolate Hydrochloride 1.0% eye drops) t.i.d for 4 weeks (to operate eye alone)

干预措施: Cyclopentolate Hydrochloride 1.0% eye drops (Drug)

结局指标

主要结局

Number of participants developed iris posterior synechiae after surgery

时间窗: 24 weeks

Iris posterior synechia is an adhesion formed between the iris and the capsular bag, which holds the implanted lens in place. It is a relatively common complication observed after intra-ocular surgery. Viewed under the slit lamp at the standard ophthalmologist examination after surgery. Mild to Moderate synechia can interrupt pupil dilatation and interfere with postoperative visualization of the fundus, thus diminishing an advantage of the combined surgery. Substantial synechia may affect the movement of the aqueous from the posterior to the anterior chamber resulting in secondary angle closure glaucoma.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yair Pesoa

Dr, Principal Investigator.

Rabin Medical Center

研究点 (1)

Loading locations...

相似试验