Randomised Controlled Trial to Evaluate the Efficacy and Safety of Lens Extraction in Patients With Pseudoexfoliation Glaucoma: a Feasibility and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- INTRAOCULAR PRESSURE
研究概览
简要总结
There are several publications that have demonstrated the protective role of cataract surgery against the development of long-term glaucoma, especially in cases of pseudoexfoliation glaucoma (PXFG). Cataract surgery in patients with pseudoexfoliation (PXF) is a procedure with higher rates of complications due to its smaller pupillary diameter and its greater zonular weakness, so lens extraction performed earlier could possibly reduce intra and postoperative complications. Given the severity and high prevalence of PXFG in our environment, investigators proposed a randomized clinical trial to evaluate the efficacy of cataract surgery in reducing the intraocular pressure (IOP) at 12 months and thereby change the course of the disease. The control group will have glaucoma treatment according to standard practice.
详细描述
INTRODUCTION
Pseudoexfoliation (PXF) is a pathology characterized by the accumulation of extracellular microfibrillar material in the anterior segment of the eye. It was first described by Lindberg in Finland in 1917 and is the most common identifiable cause of glaucoma. It is diagnosed clinically with the observation of a white-greyish fibrillar material mainly on the anterior surface of the lens, but also in the pupillary margin or other ocular tissues, as well as in other structures: blood vessels, skin, kidneys, heart, lungs or meninges, among others. It is considered a multifactorial disease that involves genetic and non-genetic factors and whose pathogenesis is based on the theory of microfibrillar elastosis, creating an excessive amount of pseudoexfoliative material that aggregates, deposits and increases resistance in the trabecular meshwork, with the consequent increase of intraocular pressure (IOP).
According to the World Health Organization, glaucoma is the leading cause of irreversible blindness in the world. Pseudoexfoliative glaucoma (PXFG) is the second most frequent subtype of glaucoma, after primary open-angle glaucoma (POAG). Its incidence increases progressively with age and the prevalence varies between countries, being estimated in the area under investigation around 6.5%, increasing to 28.3% in patients over 80 years. Its prognosis is more severe than in POAG, and the risk of developing glaucoma is between 5 and 10 times more frequent in eyes with PXF.
The current medical management for PXFG is similar to POAG, beginning with medical therapy. Sometimes it can also be associated with laser treatment, trabeculoplasty, which is effective only in the short term. As the last step we resort to glaucoma surgery, trabeculectomy, or other filtering surgeries, which have a variable success rate, and although the efficacy is similar to those of POAG, complications are more frequent in this type of patients.
There are multiple publications that have demonstrated the protective role of cataract surgery in the long-term development of glaucoma, especially in PXFG cases. It was also described a moderate reduction in IOP after phacoemulsification in PXF patients, but noted that there is still insufficient scientific evidence for more severe glaucoma or poor IOP control. This reduction in intraocular pressure seems to be maintained over time, even 7 years after the extraction of the cataract.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MEDICAL TREATMENT GROUP
Medical treatment will be used in a staggered manner and may also associate laser trabeculoplasty. If necessary, then surgical treatment would be indicated: trabeculectomy. or another filtering surgery.
Inadequate IOP control will be determined by the local ophthalmologist, and additional treatment will be indicated to achieve an target IOP.
干预措施: MEDICAL GLAUCOMA TREATMENT (Drug)
INTERVENTION GROUP
In lens extraction arm, patients will undergo lens phacoemulsification with intraocular lens implant (IOL) within 60 days after randomization.
If additional treatment is required, the same stepped sequence of therapy described for "medical treatment group" will be used and will be considered a therapeutic failure.
干预措施: PHACOEMULSIFICATION (Procedure)
结局指标
主要结局
INTRAOCULAR PRESSURE
时间窗: 12 months
The primary outcome will be the intraocular pressure (IOP) reduction 12 months after randomisation
次要结局
- VISUAL FIELD INDEX(12 months)
- INCIDENCE OF GLAUCOMA SURGERY(12 months)
- QUALITY OF LIFE. VFI Q25 CUESTIONAIRE(12 months)
- COST BENEFIT ANALYSIS(12 months)
- RATE OF RECRUITMENT(12 months)
- BEST CORRECTED VISUAL ACUITY(12 months)
- INCIDENCE OF TREATMENT ADVERSE EVENTS(12 months)
- RETINAL NERVE FIBER LAYER(12 months)
- NUMBER OF GLAUCOMA DRUGS(12 months)
研究者
SARA POSE BAZARRA
Ophthalmologist, MD
Xerencia de Xestión Integrada de Ferrol
