Glaucoma, Open-AngleTIPSNCT03274323
Trabeculectomy Versus 2-iStent and Prostaglandin Study
A study testing iStent and travoprost or latanoprost and Trabeculectomy in people with Glaucoma, Open-Angle, run by Johns Hopkins University.
Trial summary
Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- iStent and travoprost or latanoprost and Trabeculectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2018to 12 Jan 2018
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have mental capacity to give consent
- Age >= 21 years
- Pseudophakic or phakic without visually significant cataract
- Open angle glaucoma
- IOP in the range of 18-30 mmHg with 2 or more topical medications
- Cup-disc ratio =< 0.9
- Best corrected visual acuity of 20/100 or better
Who cannot join
- Inability to give consent
- Inability to tolerate or presence of allergy to prostaglandin analogs
- Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study
- Age < 21 years
- Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient
- Secondary glaucoma or angle closure glaucoma
Show all 9Show fewer
- Aphakia
- Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive Glaucoma Surgery (MIGS) surgeries, deep sclerectomy)
- Prior laser trabeculoplasty < 90 days prior to screening or absolute failure of prior laser trabeculoplasty.
About this study
Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.
Read the detailed description
This will be a prospective randomized controlled study.
20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- iStent and travoprost or latanoprost, Trabeculectomy
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iStent and travoprost or latanoprostDevice
2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure
TrabeculectomyProcedure or surgery
Standard trabeculectomy
| Study group | Role | What they receive |
|---|---|---|
| 2 iStent with travoprost or latanoprost | Experimental | 2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery Receives: Device: iStent and travoprost or latanoprost |
| trabeculectomy | Active comparator | Standard trabeculectomy Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP <= 18 mmHg
IOP
Measured: Post surgery month 4
IOP <= 15 mmHg
IOP
Measured: Post surgery month 4
IOP >= 20% reduction from untreated baseline
IOP
Measured: Post surgery month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start12 Jan 2018
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Why it stopped: Difficulty obtaining IDE by the FDA. Currently not worthwhile to pursue further.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274323
- Sponsor's protocol ID
- IRB00146334
- Acronym
- TIPS
- Status last verified
- Jan 2018
- First submitted
- 5 Sep 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trabeculectomy Versus 2-iStent and Prostaglandin Study
- ClinicalTrials.gov ID
- NCT03274323
- Acronym / sponsor ID
- TIPS / IRB00146334
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty obtaining IDE by the FDA. Currently not worthwhile to pursue further.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 6 Sep 2017 (actual)
- 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.
Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.
Detailed description
This will be a prospective randomized controlled study.
20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 iStent with travoprost or latanoprost | Experimental | Device: iStent and travoprost or latanoprost2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery |
| trabeculectomy | Active comparator | Procedure: TrabeculectomyStandard trabeculectomy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who have mental capacity to give consent
- Age >= 21 years
- Pseudophakic or phakic without visually significant cataract
- Open angle glaucoma
- IOP in the range of 18-30 mmHg with 2 or more topical medications
Key exclusion criteria (9 listed)
- Inability to give consent
- Inability to tolerate or presence of allergy to prostaglandin analogs
- Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study
- Age < 21 years
- Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient
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 |
|---|---|---|
| iStent and travoprost or latanoprost2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure | Device | 2 iStent with travoprost or latanoprost |
| TrabeculectomyStandard trabeculectomy | Procedure or surgery | trabeculectomy |
Primary outcome
IOP <= 18 mmHg
Time frame: Post surgery month 4
IOP
IOP <= 15 mmHg
Time frame: Post surgery month 4
IOP
IOP >= 20% reduction from untreated baseline
Time frame: Post surgery month 4
IOP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing iStent and travoprost or latanoprost and Trabeculectomy in people with Glaucoma, Open-Angle, run by Johns Hopkins University.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
IOP <= 18 mmHg (time frame: Post surgery month 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2018.