Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents
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|ClinicalTrials.gov Identifier: NCT02873806|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2016
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Open-angle Glaucoma||Procedure: Implantation of two iStent inject micro-bypass stents Drug: Topical travoprost Device: Two iStent inject micro-bypass stents Drug: Tobramycin Drug: Dexamethasone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2013|
|Actual Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2019|
2 micro-bypass stents & travoprost
Two iStent inject micro-bypass stents and topical travoprost
Procedure: Implantation of two iStent inject micro-bypass stents
- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
Other Name: iStent inject
Drug: Topical travoprost
- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
Other Name: travoprost
Device: Two iStent inject micro-bypass stents
- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
Other Name: iStent inject
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) .
Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):
- Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication [ Time Frame: 12 months postoperative ]
- Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication [ Time Frame: 12 months postoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873806
|S.V. Malayan's Ophtalmology Centre|
|Yerevan, Armenia, 375108|
|Principal Investigator:||Lilit Voskanyan, MD, PhD||S.V. Malayan Eye Center|