NCT03647033

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

Completed NA Results posted Last updated 31 October 2018

What this trial tests

NA trial testing iStent implantation in Primary Angle-Closure Glaucoma in 32 participants. Completed in 12 August 2017.

Timeline

14 October 2015

Primary endpoint
12 August 2016

12 August 2017

Quick facts

Lead sponsor	Khoo Teck Puat Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	32
Start date	14 October 2015
Primary completion	12 August 2016
Estimated completion	12 August 2017
Sites	1 location across Singapore

Drugs / interventions tested

• iStent implantation

Conditions studied

• Primary Angle-Closure Glaucoma — all drugs for Primary Angle-Closure Glaucoma →
• Primary Angle Closure Without Glaucoma Damage — all drugs for Primary Angle Closure Without Glaucoma Damage →

Sponsor

Khoo Teck Puat Hospital

Who can join

Adults 21 to 80, any sex, with Primary Angle-Closure Glaucoma or Primary Angle Closure Without Glaucoma Damage. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Intraocular Pressure Between Baseline and 1 Year Primary · 1 year

change in mean unmedicated intraocular pressure between baseline and 1 year

Group	Value	95% CI
Phacoemulsification Alone	15	± 2.5
Phacoemulsification and iStent	14.7	± 3.1

Change in Glaucoma Medications Secondary · 1 year

change in number of topical glaucoma medications at 1 year post operation

Group	Value	95% CI
Phacoemulsification Alone	0.75	± 1.0
Phacoemulsification and iStent	0.25	± 0.68

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phacoemulsification Alone

Serious: 0/16 (0%)

Deaths: 0/16

Phacoemulsification and iStent

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (4 terms — click to expand)

Reaction	System	Phacoemulsification Alone	Phacoemulsification and iS…
intraoperative hyphema	Eye disorders	—	—
intraoperative iris prolapse	Eye disorders	—	—
intraoperative iris trauma	Eye disorders	—	—
intraoperative iridodialysis	Eye disorders	—	—

Data from ClinicalTrials.gov NCT03647033 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.