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Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

Primary Purpose

Open-angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
Armenia
Study Type
Interventional
Intervention
Implantation of two iStent inject micro-bypass stents
Topical travoprost
Two iStent inject micro-bypass stents
Tobramycin
Dexamethasone
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Screening Exam Inclusion Criteria:

  • Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
  • Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
  • C/D ratio ≤ 0.9
  • Visual field defects, or nerve abnormality characteristic of glaucoma
  • Two topical hypotensive medications at time of screening exam
  • IOP > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam
  • Study eye BCVA 20/100 or better
  • Normal angle anatomy as determined by gonioscopy
  • Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent

Baseline Exam Inclusion Criteria:

  • Subject has completed appropriate medication washout
  • Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period
  • A 3mmHg IOP increase over screening mean IOP

Exclusion Criteria:

Screening Exam Exclusion Criteria:

  • Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
  • Prior stent implantations (study eye)
  • Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
  • Functionally significant visual field loss, including severe nerve fiber bundle defects
  • Prior incisional glaucoma surgery
  • Prior SLT within 90 days prior to screening
  • Prior ALT
  • Iridectomy or laser iridotomy
  • Ineligibility for ocular hypotensive medication washout period as determined by the investigator.
  • Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
  • Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata
  • Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability
  • Corneal opacities that would inhibit visualization of the nasal angle
  • Congenital or traumatic cataract
  • Retinal or optic nerve disorders that are not associated with the existing glaucoma condition
  • Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease
  • Clinically significant sequelae from trauma
  • Chronic ocular inflammatory disease or presence of active ocular inflammation

Baseline Exam Exclusion Criteria:

  • Subject did not complete medication washout
  • Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout
  • Subject does not have a 3mmHg IOP increase over screening mean diurnal

Sites / Locations

  • S.V. Malayan's Ophtalmology Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

2 micro-bypass stents & travoprost

Arm Description

Two iStent inject micro-bypass stents and topical travoprost Intervention: Implantation of two iStent inject micro-bypass stents Tobramycin Dexamethasone

Outcomes

Primary Outcome Measures

Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication

Secondary Outcome Measures

Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication

Full Information

First Posted
August 11, 2016
Last Updated
September 2, 2022
Sponsor
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02873806
Brief Title
Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents
Official Title
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 8, 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
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.
Detailed Description
The study design is as follows: Prospective, single-arm study. Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg. Subjects on two topical ocular hypotensive medications (one a prostaglandin). Implantation of two iStent inject devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued). IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP. Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout). Descriptive statistics will be tabulated. Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2 micro-bypass stents & travoprost
Arm Type
Other
Arm Description
Two iStent inject micro-bypass stents and topical travoprost Intervention: Implantation of two iStent inject micro-bypass stents Tobramycin Dexamethasone
Intervention Type
Procedure
Intervention Name(s)
Implantation of two iStent inject micro-bypass stents
Other Intervention Name(s)
iStent inject
Intervention Description
- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
Intervention Type
Drug
Intervention Name(s)
Topical travoprost
Other Intervention Name(s)
travoprost
Intervention Description
- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
Intervention Type
Device
Intervention Name(s)
Two iStent inject micro-bypass stents
Other Intervention Name(s)
iStent inject
Intervention Description
- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
Intervention Type
Drug
Intervention Name(s)
Tobramycin
Intervention Description
Topical antibiotic (tobramycin): 1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%): Week 1: 1 drop four (4) times per day in the study eye Week 2: 1 drop three (3) times per day in the study eye Week 3: 1 drop two (2) times per day in the study eye Week 4: 1 drop one (1) time per day in the study eye
Primary Outcome Measure Information:
Title
Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication
Time Frame
12 months postoperative
Secondary Outcome Measure Information:
Title
Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication
Time Frame
12 months postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Screening Exam Inclusion Criteria: Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs) Primary open-angle glaucoma (including pigmentary or pseudoexfoliative) C/D ratio ≤ 0.9 Visual field defects, or nerve abnormality characteristic of glaucoma Two topical hypotensive medications at time of screening exam IOP > 18 mmHg and ≤ 30 mmHg (medicated) at screening exam Study eye BCVA 20/100 or better Normal angle anatomy as determined by gonioscopy Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent Baseline Exam Inclusion Criteria: Subject has completed appropriate medication washout Mean IOP > 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period A 3mmHg IOP increase over screening mean IOP Exclusion Criteria: Screening Exam Exclusion Criteria: Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs) Prior stent implantations (study eye) Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders Functionally significant visual field loss, including severe nerve fiber bundle defects Prior incisional glaucoma surgery Prior SLT within 90 days prior to screening Prior ALT Iridectomy or laser iridotomy Ineligibility for ocular hypotensive medication washout period as determined by the investigator. Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis) Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch's dystrophy); any guttata Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability Corneal opacities that would inhibit visualization of the nasal angle Congenital or traumatic cataract Retinal or optic nerve disorders that are not associated with the existing glaucoma condition Elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; Sturge-Weber syndrome; orbital tumors; orbital congestive disease Clinically significant sequelae from trauma Chronic ocular inflammatory disease or presence of active ocular inflammation Baseline Exam Exclusion Criteria: Subject did not complete medication washout Mean IOP < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout Subject does not have a 3mmHg IOP increase over screening mean diurnal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lilit Voskanyan, MD, PhD
Organizational Affiliation
S.V. Malayan Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.V. Malayan's Ophtalmology Centre
City
Yerevan
ZIP/Postal Code
375108
Country
Armenia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28384377
Citation
Berdahl J, Voskanyan L, Myers JS, Hornbeak DM, Giamporcaro JE, Katz LJ, Samuelson TW. Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up. Clin Exp Ophthalmol. 2017 Nov;45(8):797-802. doi: 10.1111/ceo.12958. Epub 2017 Jun 2.
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Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

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