Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
1 other identifier
interventional
39
1 country
1
Brief Summary
The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Dec 2010
Longer than P75 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
December 1, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedSeptember 7, 2022
December 1, 2017
5.6 years
December 1, 2010
September 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline
12 months
Secondary Outcomes (1)
Mean diurnal IOP < 18 mmHg at month 12
12 months
Study Arms (1)
Two iStent devices and medication
EXPERIMENTALImplantation of two iStents through small temporal clear corneal incision
Interventions
Implantation of two iStents through a small temporal clear corneal incision
Eligibility Criteria
You may qualify if:
- Diagnosed with primary open-angle glaucoma (POAG)
- Subjects on two topical hypotensive medications
You may not qualify if:
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
S.V. Malayna's Ophthalmology Centre
Yerevan, 375108, Armenia
Related Publications (2)
Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, Samuelson TW. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg. 2014 Aug;40(8):1295-300. doi: 10.1016/j.jcrs.2014.07.004.
PMID: 25088627BACKGROUNDChang DF, Donnenfeld ED, Katz LJ, Voskanyan L, Ahmed II, Samuelson TW, Giamporcaro JE, Hornbeak DM, Solomon KD. Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up. Clin Ophthalmol. 2017 Mar 15;11:523-528. doi: 10.2147/OPTH.S121041. eCollection 2017.
PMID: 28352151BACKGROUND
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 3, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2016
Study Completion
December 1, 2016
Last Updated
September 7, 2022
Record last verified: 2017-12