A Clinical Trial of Phacoemulsification Versus Phacoemulsification & the iStent Implantation in POAG Patients
A Randomized, Double-Masked Clinical Trial of Phacoemulsification Compared With Phacoemulsification and Micro-Bypass Stent Implantation in Patients With POAG
1 other identifier
interventional
36
0 countries
N/A
Brief Summary
This was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent® trabecular micro-bypass stent in patients with primary open-angle glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedFebruary 19, 2009
February 1, 2009
1.2 years
February 18, 2009
February 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary outcomes included IOP and reduction in medication use.
15 month
Study Arms (2)
1
ACTIVE COMPARATORphacoemulsification alone
2
ACTIVE COMPARATORphacoemulsification and implantation of the iStent® trabecular micro-bypass stent
Interventions
phacoemulsification and implantation of the iStent® trabecular micro-bypass stent
Eligibility Criteria
You may qualify if:
- a previous diagnosis of POAG
- an IOP of \> 18 mm Hg at three separate visits if on one medication, or subjects on at least two medications with uncontrolled IOP on three separate visits.
- all patients were deemed likely to follow surgeon instructions and were able to give informed consent.
You may not qualify if:
- any glaucoma diagnosis other than POAG
- the presence of peripheral anterior synechiae (PAS)
- a cloudy cornea likely to inhibit gonioscopic view of the angle
- any previous ocular surgery
- history of trauma or ocular surface disease
- the presence of peripheral anterior synechiae (PAS)
- a cloudy cornea likely to inhibit gonioscopic view of the angle
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Fea AM, Consolandi G, Zola M, Pignata G, Cannizzo P, Lavia C, Rolle T, Grignolo FM. Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up. J Ophthalmol. 2015;2015:795357. doi: 10.1155/2015/795357. Epub 2015 Oct 26.
PMID: 26587282DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Fea, MD
University of Torino
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
December 1, 2006
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
February 19, 2009
Record last verified: 2009-02