None listed
Conditions
Brief summary
The aim of this study is to compare the positioning of the Hydrus Microstent and iStent Infinite devices after insertion into the eye for patients undergoing routine glaucoma surgery. It is predicted that by using a specialized camera to take high resolution images of the eye, the positioning of the devices will be able to be more precisely compared. The positioning of the devices will be examined at 3 months post insertion using a specialized camera which takes high resolution pictures of the eye.
Interventions
This study will compare the positioning of the Hydrus Microstent and iStent Infinite devices after insertion into the eye of patients undergoing routine glaucoma surgery.
The iStent Infinite consists of three tiny metal stents, each less than 1mm long which are inserted into the eye's natural drainage pathway to bypass blockages and allow fluid to drain more freely. The Hydrus Microstent is an eyelash-sized, U-shaped flexible scaffold implanted in the eye's natural drainage canal to provide a
This study will compare the positioning of the Hydrus Microstent and iStent Infinite devices after insertion into the eye of patients undergoing routine glaucoma surgery. The iStent Infinite consists of three tiny metal stents, each less than 1mm long which are inserted into the eye's natural drainage pathway to bypass blockages and allow fluid to drain more freely. The Hydrus Microstent is an eyelash-sized, U-shaped flexible scaffold implanted in the eye's natural drainage canal to provide a larger pathway for fluid to drain. The stents will be inserted by an ophthalmologist, and the surgery will take approximately 30 minutes. The device used will be randomly allocated based on a predefined randomisation schedule. The positioning of the devices will be examined 3 months post insertion using a specialized camera which takes high resolution images of the eye. This imaging is performed as standard for patients undergoing glaucoma surgery. The camera is a non-invasive device that contains a chin rest where you place your head to keep still while you look into a light source inside the machine. The images will be taken by an orthoptist and will take up to 15 minutes to complete.
Sponsors
Lions Eye Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age older than 18 years • Visually significant age-related cataract • Mild or moderate primary open angle glaucoma severity (as per Hodapp-Anderson-Parrish grading scale based on preoperative visual field mean deviation) • Open angle on gonioscopy: grade 3 or 4 according to Shaffer Angle Grading System • Cup-to-Disc (C:D) ratio equal to or less than 0.8 • Visual field defects with mean deviation ranging from 0 dB to -12dB (inclusive) • Pre-operative medicated or unmedicated IOP equal to or greater than 7 mmHg and equal to or less than 29 mmHg. • Current treatment with 0 to 4 ocular hypotensive medications • Planning to undergo trabecular micro-bypass with Hydrus microstent or three iStent inject W stents, in combination with phaco-emulsification cataract surgery • No previous ocular surgery • No other ocular disease
Exclusion criteria
• Those with poor quality AS-OCT images • Patients with angle closure glaucoma and/or those with angle abnormalities • Patients with secondary glaucoma including traumatic, malignant, uveitic, neovascular • Prior glaucoma surgery • Selective Laser Trabeculoplasty within 3 months from date of surgery • Plan for future ocular surgery or retinal laser • Visual field defect in 10 degrees of central field • History of intraocular surgery or inflammation • Difference of greater than 0.5mm between the two eyes in ocular biometry parameters pertaining to anterior chamber depth
Outcome results
None listed