GlaucomaPhase 3NCT02512133
MIGS VS SLT Comparison in Glaucoma Patients
A Phase 3 study testing MIGS Hydrus Ivantis and 360 degrees SLT in people with Glaucoma, run by University of Turin, Italy at 1 site in Italy.
Trial summary
To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- MIGS Hydrus Ivantis and 360 degrees SLT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Jul 2017
- Phase
- Phase 3
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy
Who cannot join
- eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MIGS VS SLT in Glaucoma Patients: Prospective Study
To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).
Read the detailed description
Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.
Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids.
- Conditions
- Glaucoma
- Being tested
- MIGS Hydrus Ivantis, 360 degrees SLT
- Keywords
- MIGS, SLT
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIGS Hydrus IvantisDevice
implant of the micro stent in the nasal Schlemm's canal
360 degrees SLTProcedure or surgery
Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ
| Study group | Role | What they receive |
|---|---|---|
| MIGS Hydrus Ivantis | Experimental | opening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control Receives: Device: MIGS Hydrus Ivantis |
| SLT | Experimental | Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ Receives: Procedure: 360 degrees SLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the intraocular pressure compared to baseline
measurement with GAT in mm Hg
Measured: up to 12 months
Secondary outcomes (1)
change in the number of glaucoma medications compared to baseline
accountability of IOP lowering medications used by the patient
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionJul 2017 (estimated)
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 GlaucomaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- University of Siena
- Responsible party
- Principal investigator, Antonio Fea, University of Turin, Italy
- Investigators
- Antonio Fea, MD, Principal investigator, Clinica Oculistica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512133
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2015
- First submitted
- 19 Jul 2015
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
PubMed 35943114
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIGS VS SLT in Glaucoma Patients: Prospective Study
- ClinicalTrials.gov ID
- NCT02512133
- Acronym / sponsor ID
- 1
- Conditions
- Glaucoma
- Keywords
- MIGS, SLT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- University of Siena
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 30 Jul 2015 (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.
To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).
Detailed description
Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.
Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIGS Hydrus Ivantis | Experimental | Device: MIGS Hydrus Ivantisopening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control |
| SLT | Experimental | Procedure: 360 degrees SLTLaser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy
Key exclusion criteria (1 listed)
- eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids
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 |
|---|---|---|
| MIGS Hydrus Ivantisimplant of the micro stent in the nasal Schlemm's canal | Device | MIGS Hydrus Ivantis |
| 360 degrees SLTLaser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ | Procedure or surgery | SLT |
Primary outcome
change in the intraocular pressure compared to baseline
Time frame: up to 12 months
measurement with GAT in mm Hg
1 secondary outcome
change in the number of glaucoma medications compared to baseline
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
- Derived from this study: PubMed 35943114Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
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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.
Antonio Fea, MD principal investigator
Clinica Oculistica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MIGS Hydrus Ivantis and 360 degrees SLT in people with Glaucoma, run by University of Turin, Italy at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2015. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
change in the intraocular pressure compared to baseline (time frame: up to 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 NCT02512133, 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 30 Jul 2015.