NCT03647033

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent Implantation in Primary Angle Closure and Primary Angle Closure Glaucoma: Randomized Double-masked Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Khoo Teck Puat Hospital · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Assessing the safety and efficacy of a micro-bypass stent in combination with cataract surgery in subjects with primary angle closure. Subjects are randomized into two arms: phacoemulsification cataract surgery alone versus phacoemulsification cataract surgery combined with the micro-bypass stent implantation. Post surgery intraocular eye pressure will be recorded to assess the efficacy of both arms.

Detailed description

Aim: To assess the safety and efficacy of the iStent trabecular micro-bypass stent (Glaukos Corporation, Laguna Hills, CA) in combination with cataract surgery in subjects with primary angle closure and mild to moderate primary angle closure glaucoma Method: Prospective, randomised controlled trial, blinded to patient and intra-ocular pressure measuring staff. 32 patients, 1:1 ratio, in 2 arms of phacoemulsification alone compared to phacoemulsification with iStent. Hypothesis: Phacoemulsification with micro-bypass stent has a better intraocular pressure (IOP) lowering effect compared to phacoemulsification alone in primary angle closure and primary angle closure glaucoma at 1 year after surgery. Importance: Primary angle closure and primary angle closure glaucoma are conventionally treated with eye drops that lower the intraocular pressure (IOP). Phacoemulsification/lens extraction can often help lower the eye pressure by widening the drainage angle and via ultrasound mechanisms, however, in some cases the IOP is not lowered, or even can cause the IOP to be higher. The iStent implant can be used together with phacoemulsification to lower the IOP and in Primary open angle glaucoma, it gives an additional 20% IOP reduction. It is unclear what effect the iStent has in primary angle closure or primary angle closure glaucoma as it has never been studied. It is important because primary angle closure glaucoma is much more common in the Singaporean Chinese population and the iStent can potentially be used to control the IOP instead of conventional eye drops and glaucoma surgery which have their own potential adverse effects. Potential Benefits: iStent with phacoemulsification may control the IOP better than phacoemulsification alone, reduce the need for IOP lowering medication after surgery, and prevent the need for glaucoma surgery in the future. Potential Risks: The iStent has risks of IOP spikes, bleeding in the anterior chamber and iStent dislocation.Phacoemulsification has the risks of: infection, bleeding, reduced vision, inflammation, posterior capsular rupture, vitreous loss, retinal detachment, endophthalmitis, suprachoroidal haemorrhage and Intraocular Lens dislocation.

Conditions

• Primary Angle-Closure Glaucoma
• Primary Angle Closure Without Glaucoma Damage

Interventions

Type	Name	Description
DEVICE	iStent implantation	The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.

Timeline

• Start date: 2015-10-14
• Primary completion: 2016-08-12
• Completion: 2017-08-12
• First posted: 2018-08-27
• Last updated: 2018-10-31
• Results posted: 2018-10-02

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated device study