Anterior Segment Changes Before and After Uneventful Combined Phaco-Trabeculectomy by Using Optical Coherence Tomography (OCT)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Biometric parameters measured with the AS-OCT (AC depth (ACD)) after surgery. - anterior chamber depth in mm
研究概览
简要总结
- Develop a measurement protocol by OCT imaging and characterization of the anterior chamber change in glaucoma patients before and after surgery.
- Show the effect of combined surgery in control of intra ocular pressure.
详细描述
Definitions Glaucoma represents a group of diseases defined by a characteristic optic neuropathy that is consistent with excavation and undermining of the neural and connective tissue elements of the optic disc and by the eventual development of distinctive patterns of visual dysfunction .Pre-perimetric glaucoma is a term that is sometimes used to denote glaucomatous changes in the optic disc in patients with normal visual fields.
Glaucoma and cataract incidence increases with age. Special considerations are needed when choosing which surgical strategy to undertake when either of these two conditions requires surgical management. When performed prior to cataract surgery, trabeculectomy increases the risk of cataract formation by up to 78%, while subsequent cataract surgery may increase the risk of elevated intraocular pressure or trabeculectomy failure. By contrast, when cataract surgery alone is performed in glaucoma patients; an early postoperative intraocular pressure spike sometimes requiring medical treatment is commonly reported. Therefore, phacotrabeculectomy, a procedure that combines the management of these two conditions together in one surgery, may be considered in these situations.
When to Consider Combined Surgery
Combined cataract extraction and glaucoma surgery (trabeculectomy, glaucoma drainage implant surgery, or any of the newer surgical approaches for glaucoma) should be carefully selected and individualized depending on clinical findings in each case:
- Cataract surgery alone is sufficient for patients with well controlled in intraocular pressure in the setting of early to moderate optic nerve damage.
- Patients with uncontrolled intraocular pressure in the presence of severe optic nerve damage should receive glaucoma surgery first, followed by cataract extraction a few months later
- Combined surgery may be best suited for a patient with a visually significant cataract with uncontrolled glaucoma despite maximal medical therapy and/or laser trabeculoplasty. Cost is often an issue for many patients and eliminating medications can help reduce the financial burden. Poor compliance with glaucoma medications can also be an issue to consider both procedures together.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged over 18 years
- •Diagnosed primary open angle glaucoma
- •Visual field defects and optic nerve head appearance characteristic for glaucoma
- •Angle closure predisposition as evidenced from gonioscopy.
- •Neovascularization in the anterior chamber angle
- •pseudo-exfoliation glaucoma as evidenced from slit lamp examination
- •No cataract surgery.
- •No glaucoma surgery
- •No degenerative changes in the retina in funduscopy after mydriasis
排除标准
- •-previous glaucoma surgery
- •Previous cataract surgery
- •Presence of any abnormalities preventing reliable measurements
- •Ocular inflammation and ocular disease interfering with the study
- •Corneal, macula, and other corneal disease.
- •No fixation Funds lesions such as diabetic retinopathy or retinal detachment.
研究组 & 干预措施
study group
They will be subjected to:
Preoperative A-complete ophthalmic examination will be done for every patient; B- Biometric parameters measured with the AS-OCT C- Medical fitness for all patients D- Informed consent will be obtained from all patients after through explanation of operation and its potential benefits and risks.
Surgery combined Phaco trabeculectomy
Post operative:
-Follow-up examinations will be performed for every patient at 1day, 1 week, 1 and 3 months postoperatively.
and biometric parameters measured with the AS-OCT before and after the surgery will be used to collect the data.
-The data will be managed and analysed with confidentiality by scientifically qualified persons
干预措施: phaco- trabeculectomy (Procedure)
结局指标
主要结局
Biometric parameters measured with the AS-OCT (AC depth (ACD)) after surgery. - anterior chamber depth in mm
时间窗: one week post operative
anterior chamber depth in mm Distance from corneal endothelium to anterior surface of the lens
次要结局
- other biometric parameters measured with the AS-OCT,(1,3,6, month postoperative)
- intra ocular pressure(1,3,6, month postoperative)
研究者
shymaa kamel Ibrahim Hady
principal investigator
Assiut University
