N/A N=32 Randomized Double-blind Treatment

Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent

Primary Angle-Closure Glaucoma · Primary Angle Closure Without Glaucoma Damage

Bottom Line

View on ClinicalTrials.gov: NCT03647033 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Change in Intraocular Pressure Between Baseline and 1 Year — 15; 14.7 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: iStent implantation (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Khoo Teck Puat Hospital
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Intraocular Pressure Between Baseline and 1 Year	15; 14.7	—
SECONDARY Change in Glaucoma Medications	0.75; 0.25	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03647033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.