1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) - 


6. For how long will this data be available start date provided 02-12-2022 and end date provided 02-12-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

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