N/A
Completed N=32
Phacoemulsification Versus Phacoemulsification With Micro-bypass Stent
Primary Angle Closure Glaucoma · Primary Angle Closure Without Glaucoma Damage
Source: ClinicalTrials.gov NCT03647033 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Change in Intraocular Pressure Between Baseline and 1 Year — 15; 14.7 mmHg
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.
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 | — |
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
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. Informational only — not medical advice.