Novel Technique of Pneumatic Posterior Capsulorhexis for Treatment and Prevention of Posterior Capsular Opacification
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
- 是
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
PCO
干预措施: Pneumatic Posterior Capsulorhexis (Procedure)
Clear posterior capsule
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
Shaaban Elwan
Assistant professor of ophthalmology
Minia University
