Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

Khoo Teck Puat Hospital

Status: Completed

Conditions: Primary Angle-Closure Glaucoma; Primary Angle Closure Without Glaucoma Damage

Treatments: Device: iStent implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03647033

2015/00644

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• able to provide informed consent
• Previous diagnosis of Primary Angle Closure or Primary Angle Closure Glaucoma
• Intraocular Pressure above 21mmHg at 3 separate visits
• On 1 or more hypotensive medications
• Pre-operative visual acuity of no better than 6/12

Exclusion criteria

• Other glaucoma diagnosis: Primary Open Angle Glaucoma, secondary glaucoma
• Peripheral Anterior Synechiae in the nasal and inferior quadrant
• Cloudy cornea affecting view for iStent implantation
• Previous glaucoma surgery
• History of Ocular trauma
• Ocular surface disease
• Pre-proliferative or proliferative diabetic retinopathy
• Age related macular degeneration with macular scar or macular atrophy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

phacoemulsification alone

No Intervention group

Description:

routine phacoemulsification cataract surgery with intraocular lens implantation

phacoemulsification and iStent

Experimental group

Description:

phacoemulsification cataract surgery with intraocular lens implantation combined with iStent implantation

Treatment:

Device: iStent implantation