Filtering SurgeryLongGVTNCT05126069
Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis
An observational study of Filtering Surgery and Trabeculectomy, run by Prism Eye Institute at 1 site in Canada.
Trial summary
To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Filtering Surgery, Trabeculectomy
- What is being tested?
- Ab interno gelatin microstent and Trabeculectomy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 242 participants
- Where
- 1 siteCanada
- Study dates
- 21 Aug 2018to 28 Aug 2020
- Phase
- Observational
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma patients who received received a gelatin stent 45 with MMC (mitomycin C) or a trabeculectomy with MMC
Who may be able to join
- Patients aged 30-90
- primary or pigmentary/pseudoexfoliative open angle, primary closed angle, narrow angle or combined mechanism glaucoma
- IOP of 18-40 on maximum tolerated medical therapy
- received a gelatin stent 45 with MMC or a trabeculectomy with MMC at Prism Eye Institute from June 2012 to July 2018, and have at least 3 years of follow-up.
Who cannot join
- Other forms of glaucoma
- prior incisional glaucoma surgery
- CPC
- combined surgery (cataract, cornea, or retina)
- prior corneal graft (PKP, DALK, DSAEK, DMEK)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Gelatin Stent vs. Trabeculectomy (LongGVT Study): Ab Interno Gelatin Stent With Mitomycin C Versus Trabeculectomy With Mitomycin C: a Retrospective Cohort Analysis
To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy.
Read the detailed description
This is a single-center retrospective cohort study. Patients included were consecutive patients from June 2012 - July 2017 who received standalone Xen45® or standalone trabeculectomy. The primary outcome was time to failure, defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling). Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.
- Conditions
- Filtering Surgery, Trabeculectomy
- Being tested
- Ab interno gelatin microstent, Trabeculectomy
- Keywords
- Xen, Ab Interno Gelatin Microstent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ab interno gelatin microstentDevice
Ab interno gelatin microstent
TrabeculectomyProcedure or surgery
Trabeculectomy
| Study group | Role | What they receive |
|---|---|---|
| Standalone Xen45 | consecutive patients from June 2012 - July 2017 who received standalone Xen45® Receives: Device: Ab interno gelatin microstent | |
| Standalone Trabeculectomy | consecutive patients from June 2012 - July 2017 who received standalone trabeculectomy Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to failure
defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling)
Measured: up to 3 years
Secondary outcomes (1)
included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations
Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start21 Aug 2018
- Primary completion1 May 2019
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Filtering SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prism Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iqbal Ahmed, Prism Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126069
- Sponsor's protocol ID
- 2018-10376
- Other IDs
- 2018
- Acronym
- LongGVT
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
J Liu, M Schlenker, I Ahmed. Long-Term Efficacy & Safety of Standalone Ab Interno Gelatin Microstent Implantation with MMC Vs. Trabeculectomy with MMC: 3 Year Follow-up. ASCRS Conference 2021.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Gelatin Stent vs. Trabeculectomy (LongGVT Study): Ab Interno Gelatin Stent With Mitomycin C Versus Trabeculectomy With Mitomycin C: a Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT05126069
- Acronym / sponsor ID
- LongGVT / 2018-10376
- Conditions
- Filtering Surgery, Trabeculectomy
- Keywords
- Xen, Ab Interno Gelatin Microstent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Prism Eye InstituteUniversity, hospital or other
- Study start
- 21 Aug 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 18 Nov 2021 (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.
To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy.
Detailed description
This is a single-center retrospective cohort study. Patients included were consecutive patients from June 2012 - July 2017 who received standalone Xen45® or standalone trabeculectomy. The primary outcome was time to failure, defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling). Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standalone Xen45 | – | Device: Ab interno gelatin microstentconsecutive patients from June 2012 - July 2017 who received standalone Xen45® |
| Standalone Trabeculectomy | – | Procedure: Trabeculectomyconsecutive patients from June 2012 - July 2017 who received standalone trabeculectomy |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients who received received a gelatin stent 45 with MMC (mitomycin C) or a trabeculectomy with MMC
Key inclusion criteria (4 listed)
- Patients aged 30-90
- primary or pigmentary/pseudoexfoliative open angle, primary closed angle, narrow angle or combined mechanism glaucoma
- IOP of 18-40 on maximum tolerated medical therapy
- received a gelatin stent 45 with MMC or a trabeculectomy with MMC at Prism Eye Institute from June 2012 to July 2018, and have at least 3 years of follow-up.
Key exclusion criteria (5 listed)
- Other forms of glaucoma
- prior incisional glaucoma surgery
- CPC
- combined surgery (cataract, cornea, or retina)
- prior corneal graft (PKP, DALK, DSAEK, DMEK)
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 |
|---|---|---|
| Ab interno gelatin microstentAb interno gelatin microstent | Device | Standalone Xen45 |
| TrabeculectomyTrabeculectomy | Procedure or surgery | Standalone Trabeculectomy |
Primary outcome
time to failure
Time frame: up to 3 years
defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling)
1 secondary outcome
included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations
Time frame: up to 3 years
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 18 Nov 2021.
- Results publicationJ Liu, M Schlenker, I Ahmed. Long-Term Efficacy & Safety of Standalone Ab Interno Gelatin Microstent Implantation with MMC Vs. Trabeculectomy with MMC: 3 Year Follow-up. ASCRS Conference 2021.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Filtering Surgery and Trabeculectomy, run by Prism Eye Institute at 1 site in Canada.
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 4 inclusion and 5 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 18 Nov 2021. 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 Canada. 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.
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?
time to failure (time frame: up to 3 years). 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 NCT05126069, which also lists 1 linked publication.
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 18 Nov 2021.