Back to resultsOpen-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents
Primary Purpose
Open-Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
iStent and iStent supra
Sponsored by
About this trial
This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open angle glaucoma, Prior trabeculectomy
Eligibility Criteria
Inclusion Criteria:
- Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
- Open-angle glaucoma (including pseudoexfoliative)
Exclusion Criteria:
- Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
- Prior ALT
- Prior SLT within 90 days of screening visit
Sites / Locations
- S.V. Malayan Ophthalmological Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
iStent and iStent supra
Arm Description
Implantation of two iStent devices and one iStent supra device
Outcomes
Primary Outcome Measures
Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit
Secondary Outcome Measures
Mean diurnal IOP < 18mm Hg
Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit
Full Information
NCT ID
NCT01456390
First Posted
September 28, 2011
Last Updated
September 2, 2022
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01456390
Brief Title
Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents
Official Title
A Prospective Evaluation of Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents and a Postoperative Prostaglandin
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
March 26, 2019 (Actual)
Study Completion Date
March 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.
Detailed Description
Evaluation in the eyes of subjects with one prior trabeculectomy on one to three ocular hypotensive medications of the intraocular pressure (IOP) lowering effect of two iStent stents in combination with one iStent supra stent and a postoperative prostaglandin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-Angle Glaucoma
Keywords
Open angle glaucoma, Prior trabeculectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iStent and iStent supra
Arm Type
Other
Arm Description
Implantation of two iStent devices and one iStent supra device
Intervention Type
Device
Intervention Name(s)
iStent and iStent supra
Intervention Description
Implantation of two iStent devices and one iStent supra device
Primary Outcome Measure Information:
Title
Subjects observed at Month 12 who experience a mean medicated diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP
Description
Primary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP reduction of ≥ 20% vs. baseline mean diurnal IOP, had no glaucoma surgical procedures (incisional or laser surgery prior to the 12 month visit), and no postoperative procedure to reposition or remove the stent prior to the 12 month visit, or additional ocular hypotensive medications within 4 weeks of the Month 12 visit
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Mean diurnal IOP < 18mm Hg
Description
Secondary: Subjects observed at the Month 12 visit who experience a mean diurnal IOP < 18 mmHg, had no glaucoma surgical procedures (incisional or laser surgery) prior to the 12 month visit, and no postoperative procedure to reposition or remove the stent prior to the 12 month visit or additional ocular hypotensive medications within 4 weeks of the Month 12 visit
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Safety/adverse event monitoring
Description
Rate of ocular adverse events through 61 months
Findings from IOP, best corrected visual acuity, visual field, specular microscopy measurements
Findings from slit-lamp, fundus and gonioscopic examinations
Time Frame
0-61 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
Open-angle glaucoma (including pseudoexfoliative)
Exclusion Criteria:
Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
Prior ALT
Prior SLT within 90 days of screening visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilit A Voskanyan, MD, PhD
Organizational Affiliation
S.V. Malayan Ophthalmological Center, Yerevan, Armenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.V. Malayan Ophthalmological Center
City
Yerevan
ZIP/Postal Code
0001
Country
Armenia
12. IPD Sharing Statement
Citations:
PubMed Identifier
29476443
Citation
Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23.
Results Reference
derived
Learn more about this trial
Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents
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