Aqueous angiography in congenital, high pressure juvenile glaucoma and adult onset glaucomas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ·To establish the aqueous outflow patterns in normal healthy subjects undergoing cataract surgery
研究概览
简要总结
Glaucoma involves resistance in aqueous outflow channels which can be either at level of thetrabecular meshwork, conventional outflow channels, Schlemm’s canal, collector channels, aqueous, episcleral vein or further down distally. Histological study, the most common analysis endpoint, is not possible in patients. Therefore, real-time imaging that avoids the need to process tissue for analyses is required. Though histopathological evidence to all this exists, there was no technology for in vivo visualization of these structures before the advent of aqueous angiography, which was developed by Huang et al in 2017 and is a form of invasive real-time aqueous outflow channel imaging.
As of now, aqueous angiography experiments have been validated in live human non- glaucomatous eyes undergoing cataract surgery using tracer molecules like fluorescein and ICG dye. These experiments have shown segmental pulsatile patterns of aqueous outflow, with maximum flow localized around nasal and inferior segments in normal human eyes. Because fluorescein and ICG are both tracers recommended to stain lens capsule during cataract surgery with no side effects, additional capsular staining was unnecessary following their use. Following the injection of tracer at constant pressure through intracameral infusion, the flow through outflow channels can be visualised through the FLEX arm of Heidelberg Spectralis module which is the standard Spectralis mounted on a surgical boom arm (Heidelberg Inc., Germany).
As the majority of results have been acquired from normal human eyes, there is an unmet need and tremendous potential to better study glaucomatous eyes. Potential clinical relevance for aqueous angiography has been established using Minimally Invasive Glaucoma Surgeries (MIGS). MIGS are a new category of glaucoma surgery well known for their ease, speed of surgery, and low risk profile. The most common MIGS are the trabecular-type where the TM is either ablated or bypassed. While successful in lowering IOP, MIGS have shown some inconsistency in their outcomes.
Therefore, aqueous angiography has tremendous potential in demonstrating the real-time dysgenesis and pathophysiology of AHO channels that is present in congenital, developmental and adult-onset glaucomas. This research can uncover the reason for ocular hypertension in these subjects. Hence we aim to apply aqueous angiography in different subsets of glaucoma eyes. This information can potentially open up new avenues for glaucoma therapy development in these eyes with potentially refractory disease.
Objectives
· To establish the aqueous outflow patterns in normal healthy subjects undergoing cataract surgery
· To ascertain the aqueous outflow patterns in glaucomatous eyes with, congenital glaucoma, juvenile onset high pressure glaucomas, and late onset adult primary open angle glaucomas
· To establish phenotypic-functional relationship between the disease severity and the amount of aqueous angiographic signal
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •This will be a pilot study to analyze the aqueous angiographic signals from representative groups of Congenital glaucoma, Juvenile open angle glaucoma and Primary open angle glaucoma patients who will be posted for cataract or trabeculectomy surgery in the routine Operation theatre.
- •Cases: 10 cases each ofCongenital glaucoma, Juvenile open angle glaucoma, Primary open angle glaucoma patientsand controls who will be already posted in the OT for either cataract surgery or filtering glaucoma surgery.
- •The diagnostic criteria for each of the condition will be defined as below: Congenital glaucoma Inclusion criteria for congenital glaucoma will be as follows: untreated/unoperatedcases of congenital glaucoma with enlarged corneal diameters (>12 mm) who are diagnosed with baseline IOP records of >22 mm Hg detected before 3 years of age and are scheduled for IOP lowering surgery under general anaesthesia.
- •Adult-Onset POAG These will be unrelated POAG patients diagnosed after the age of 40 years presenting with high baseline IOP>25mmHg, scheduled for IOP lowering/ cataract surgery would be included.
- •Only those eyes that had not undergone previous surgery would be included.
- •They will be diagnosed based on open angle on gonioscopy in both eyes, and glaucomatous optic neuropathy in one or both eyes with visual field loss consistent with optic nerve damage.
- •JOAG Patients These will be unrelated POAG patients diagnosed between 10 and 40 years of age presenting with high baseline IOP>25mmHg, scheduled for IOP lowering/ cataract surgery would be included.
排除标准
- •Patients excluded from the study: those with a history of steroid use, presence of any other retinal or neurologic pathology, evidence of secondary causes of raised IOP such as pigment dispersion, pseudoexfoliation, or trauma, those with any pathology detected on gonioscopy such as angle recession, pigmentation of the angle greater than grade 3, irido-trabecular contact or peripheral anterior synechiae, and patients with nystagmus will be excluded.
结局指标
主要结局
·To establish the aqueous outflow patterns in normal healthy subjects undergoing cataract surgery
时间窗: It will be assessed at baseline once only as this is a cross sectional study with no follow up required.
·To ascertain the aqueous outflow patterns in glaucomatous eyes with, congenital glaucoma, juvenile onset high pressure glaucomas, and late onset adult primary open angle glaucomas
时间窗: It will be assessed at baseline once only as this is a cross sectional study with no follow up required.
·To establish phenotypic-functional relationship between the disease severity and the amount of aqueous angiographic signal.
时间窗: It will be assessed at baseline once only as this is a cross sectional study with no follow up required.
次要结局
- 1. To establish phenotypic-functional relationship between the disease severity and the amount of aqueous angiographic signal.(2. to determine the time delay in hagiographic flow in different groups of subjects.)