Subjects With Primary Open-angle Glaucoma (POAG)Phase 4NCT01252888
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
A Phase 4 study testing iStents in people with Subjects With Primary Open-angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Armenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subjects With Primary Open-angle Glaucoma (POAG)
- What is being tested?
- iStents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteArmenia
- Study dates
- Dec 2010to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with primary open-angle glaucoma (POAG)
- Subjects on two topical hypotensive medications
Who cannot join
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
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.
Read the detailed description
This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.
- Being tested
- iStents
- Keywords
- Open angle, Glaucoma, Surgery, Glaucoma Open-Angle, Ocular Hypertension, Eye Diseases
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStentsDevice
Implantation of two iStents through a small temporal clear corneal incision
| Study group | Role | What they receive |
|---|---|---|
| Two iStent devices and medication | Experimental | Implantation of two iStents through small temporal clear corneal incision Receives: Device: iStents |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline
Measured: 12 months
Secondary outcomes (1)
Mean diurnal IOP < 18 mmHg at month 12
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subjects With Primary Open-angle Glaucoma (POAG)Studies of the same condition, open and under way.
- More trials run by Glaukos CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252888
- Sponsor's protocol ID
- GCF-018
- Status last verified
- Dec 2017
- First submitted
- 1 Dec 2010
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25088627Chang 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.
PubMed 28352151
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
- ClinicalTrials.gov ID
- NCT01252888
- Acronym / sponsor ID
- GCF-018
- Keywords
- Open angle, Glaucoma, Surgery, Glaucoma Open-Angle, Ocular Hypertension, Eye Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2010 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Two iStent devices and medication | Experimental | Device: iStentsImplantation of two iStents through small temporal clear corneal incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with primary open-angle glaucoma (POAG)
- Subjects on two topical hypotensive medications
Key exclusion criteria (2 listed)
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iStentsImplantation of two iStents through a small temporal clear corneal incision | Device | Two iStent devices and medication |
Primary outcome
mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline
Time frame: 12 months
1 secondary outcome
Mean diurnal IOP < 18 mmHg at month 12
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Background: PubMed 25088627Ahmed 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.
- Background: PubMed 28352151Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iStents in people with Subjects With Primary Open-angle Glaucoma (POAG), run by Glaukos Corporation at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01252888, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.