跳至主要内容
临床试验/NCT04007965
NCT04007965已完成不适用

Novel Technique of Pneumatic Posterior Capsulorhexis for Treatment and Prevention of Posterior Capsular Opacification

Minia University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Visual Axis Opacification

研究概览

简要总结

ABSTRACT PURPOSE: To evaluate a new technique of posterior capsulorhexis using air support to treat primary posterior capsular opacification (PCO) during cataract extraction surgery or to prevent post-operative PCO.

SETTING: 1-Ophthalmology department, Faculty of medicine, Minia University, El-Minia, Egypt.

2- Security Forces Hospital, Ophthalmology Department, Riyadh, Kingdom of Saudi Arabia.

DESIGN: Prospective, randomized case-control comparative study.

Methods: 100 eyes of 100 patients with a mean age of 63.3 years with dens cataract. Fifty of them ( group 1) with primary PCO (discovered during the operations) and fifty (group 2) with clear posterior capsule.

All cases undergone phacoemulsification, posterior capsulorhexis using the air to support the posterior capsule and separate it from the vitreous (the novel technique will be discussed later). Then IOL implantations wear done in the bag between the anterior and posterior capsular rim. Each patient was evaluated for the following:- visual acuity (UCVA and BCVA), intraocular pressure, intra ocular lens stability, visual axis opacification and posterior segment complications as retinal break, retinal detachment or cystoid macular oedema.

详细描述

Introduction. Posterior capsular opacification (PCO) is one of the common late post-operative complications of phacoemulsification and ECCE. The treatment of PCO by YAG laser capsulotomy usually leads to the famous annoying symptom (musca) and carries the risk of IOP elevation. Moreover, it may lead to the posterior segment complications ( cystoid macular edema, retinal breaks and detachment). There is no reliable treatment for prevention of PCO.

The current available modalities to prevent postoperative PCO are:

  • Some surgical modifications as hydrodissection, repeated nucleus rotation and meticulous polishing of the lens epithelial cells (LECs) from anterior capsular rim and equator. In 1989 David Apple and his group (1) had demonstrated the value of hydrodissection. In 1992, they further emphasized hydrodissection as well as barriers to migration of equatorial cells to the posterior capsule as methods which could reduce PCO (2). In the same year Fine described a technique which he termed 'cortical cleaving hydrodissection', (3) which was designed to break the equatorial adhesions between lens epithelial cells and the capsule, thus increasing the chance of significant clearance of these cells which are the progenitors of PCO. In 2006 they pointed out to the laboratory and clinical evidence that good hydrodissection, coupled with mechanical 'scouring' of LECs from the equator may have beneficial effect on decreasing PCO incidence. (4,5). In a laboratory experiment they found that there were significantly fewer cells remaining in the capsule equator in the group of eyes where the lens had been rotated three times within the bag prior to removal, compared with no such rotation(4).
  • Changes in the IOL design and materials: e.g. The square edge of the optic and acrylic IOL decreases the incidence of postoperative PCO than with PMMA IOLs of similar design.
  • Pharmacological strategies either to kill the residual epithelial cells or to prevent their post operative proliferation. The pharmacological prevention has been largely unsuccessful so far. Moreover, any agent must be toxic to these epithelial cells without being toxic to the corneal endothelium. Few agents have been partially successful without clinical application till now (6).

The incidence of PCO following successful cataract surgery has been falling since the general acceptance of posterior chamber in-the-bag intraocular lens (IOL) implantation. Improvement in lens materials, lens design and technique are well documented to decrease the incidence of postoperative PCO (8, 9). Rotation three times of the hydrodissected nucleus prior to phacoemulsification and a second hydrodissection after nucleus removal are simple and safe maneuvers that statistically improve the results (9). Bimanual irrigation/aspiration may also help.(10) Treatment options for PCO

  • YAG laser posterior capsulotomy
  • Surgical posterior capsulotomy or capsulectomy
  • Primary (Intra-operative)
  • Secondary.

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
None

入排标准

年龄范围
50 Years 至 73 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dense mature cataract without any local or systemic causes for the cataract.

排除标准

  • Any patients did not complete the follow up visits
  • younger patients and children

研究组 & 干预措施

Opacified posterior capsule

Experimental

PCO

干预措施: Pneumatic Posterior Capsulorhexis (Procedure)

Clear posterior capsule

Active Comparator

CPC

干预措施: Pneumatic Posterior Capsulorhexis (Procedure)

结局指标

主要结局

Visual Axis Opacification

时间窗: 0ne year

Visual Axis Opacification seen by slit lamb examination

IOL stability

时间窗: one year

Intraocular Lens stability seen by slit lamb examination

IOP measured in numerical values

时间窗: one year

Intra-ocular pressure measured by Tono pen

Visual acuity measured using snellen chart projector

时间窗: one year

visual acuity (UCVA and BCVA) measured in decimal values

次要结局

  • posterior segment complications(18 months)

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaaban Elwan

Assistant professor of ophthalmology

Minia University

研究点 (2)

Loading locations...

相似试验