OMNI System in Pseudophakic Eyes. Version C
Research type
Research Study
Full title
A PROSPECTIVE, RANDOMIZED, MULTICENTER STUDY TO COMPARE THE SAFETY AND EFFECTIVENESS OF THE OMNI® SURGICAL SYSTEM AND THE ISTENT INJECT IN PSEUDOPHAKIC EYES WITH OPEN ANGLE GLAUCOMA. THE TRIDENT EUROPEAN TRIAL
IRAS ID
292658
Contact name
Gus Gazzard
Contact email
Sponsor organisation
Sight Sciences
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
A prospective, randomized, multicentre, postmarket study to compare the safety and effectiveness of the omni® surgical system and the iStent inject in pseudophakic eyes (eyes with artificial lens’ implanted) with open angle glaucoma.Our eyes make a liquid called “intraocular fluid or aqueous humor” that continuously flows through the eye to provide important nutrients to parts of the eye and give the eye its shape. This fluid is constantly circulated or flushed out of the eye through a drainage system called ‘outflow system’. Sometimes blockages can develop in way of this drainage system and thus the fluid cannot leave the eye easily; this causes the fluid pressure inside the eye (also known as intraocular pressure) to rise like having too much water in a balloon. Abnormally high pressure can lead to the disease called glaucoma. Open angle glaucoma (OAG) is the most common type of glaucoma. This disease can cause damage to the eye which may lead to permanent loss of vision or blindness. The pressure inside the eye may be lowered by using medication, laser treatment or surgery.
The Ocular Hypertension Treatment Study showed that Topical ocular hypotensive medication was effective in delaying or preventing the onset of Primary OAG in individuals with elevated IOP. Another study showed that using laser treatment reduced the risk of disease progressing at 6 years to half of that for subject that were untreated.
Although medical therapy is generally the first line of treatment, to successfully control the progression of intraocular pressure largely depends on patient adherence.
The purpose of this study is to evaluate and compare the safety and effectiveness of the OMNI CE marked device when it is used for surgical procedures called canaloplasty and trabeculotomy in patients with OAG.
Minimally (or micro) invasive glaucoma surgery (MIGS) provides an alternative to more invasive surgical methods (i.e. trabeculectomy or glaucoma drainage devices) or to laser procedures. MIGS procedures can generally be done along with cataract surgery minimizing additional risk or as standalone procedures. Several studies have demonstrated MIGS to provide long-term IOP lowering and the potential to reduce or eliminate the need for medications (and therefore reliance on patient adherence).
The OMNI Surgical System (Sight Sciences Inc, Menlo Park, CA) is a CE marked, manually operated device. OMNI helps improve fluid drainage inside the eye by enlarging and opening the normal pathway for fluid to leave the eye. The OMNI device does this by dispensing a small amount of a thick fluid (gel-like) into this pathway (called Schlemm’s canal). The amount is usually between a little less than one fourth of a drop to a little less than one half of a drop. The gel like substance is safe and is used in the eye for procedures such as cataract surgery. The second way the OMNI helps to improve drainage is by cutting a thin layer of tissue (called the trabecular meshwork) that can block the flow of fluid into the drainage pathway along with the enlargement procedure described above. These two procedures may help the fluid in your eye, flow out more freely through the natural path and lower your eye pressure.
The iStent inject (Glaukos Corp., San Clemente, CA) is a CE marked device and is implanted or inserted inside the trabecular meshwork of your eye by your doctor to help lower the fluid pressure inside the eye by allowing fluid to flow out freely through an artificial pathway.The OMNI device is being tested for these procedures to determine whether it is effective in lowering Intraocular Pressure (IOP) in eyes with OAG, compared to an iStent inject- another CE marked device to treat glaucoma.
Study subject participation will be for approximately 12 months, 5 days (at a minimum) to 14 months, depending on the length of the required medication washout prior to baseline and if a terminal washout is needed (required for subjects presenting at the Month 12 visit and on ocular hypotensive medication). A minimum of 22 sites in the European Union, United Kingdom, and/or Switzerland. A total of 459 subjects will be randomized in an equal allocation ratio (1:1:1) to either the OMNI (canaloplasty AND trabeculotomy), OMNI (canaloplasty only), or iStent inject and followed for 12 months after surgery
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0070
Date of REC Opinion
28 Apr 2021
REC opinion
Further Information Favourable Opinion