Glaucoma, Open-AngleNCT04900142
Micropulsed Laser Trabeculoplasty Using Different Parameters
A study testing Micropulsed laser trabeculoplasty in people with Glaucoma, Open-Angle, run by University of Modena and Reggio Emilia at 2 sites in Italy.
Trial summary
This randomized, double blinded, clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma. Group one is treated with 1500 mW of Power, Group two with 1000 mW. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Micropulsed laser trabeculoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Mar 2020to 20 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary open angle glaucoma
- Pigmentary glaucoma
- Pseudoexfoliative glaucoma
Who cannot join
- Secondary glaucoma
- Previous glaucoma surgery
- Severely decompensated glaucoma
- Corneal endothelial disease
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Policlinico di Modena
Modena, 41124
Tommaso Verdina, MD, PhD, +390594225047, tommaso.verdina@gmail.com
Bruno Battaglia, MD
- Recruiting
Policlinico di Modena
Modena
Matteo Gironi, 0594225087, matteo.gironi@hotmail.it
About this study
Official title: Micropulsed Laser Trabeculoplasty: a Randomized Double Blinded Clinical Trial Using Different Parameters
This randomized, double blinded, clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma. Group one is treated with 1500 mW of Power, Group two with 1000 mW. The other settings (300 micron of diameter, 300 ms of duration, 15% duty cycle) are the same for both groups, and the laser is applied for 360°.
The main outcome is to evaluate the IOP (IntraOcular Pressure) lowering effects of both treatments and the safety on the corneal endothelium.
Read the detailed description
This study is a randomized, double blinded, clinical trial. Eligibility criteria are: primary open angle glaucoma, pigmentary glaucoma and pseudoexfoliation glaucoma.
Exclusion criteria are: secondary glaucoma, previous glaucoma surgery (not including cataract surgery as a glaucoma surgery), uncooperative patients, corneal endothelial diseases (such as Fuchs dystrophy or cornea guttata) and severely decompensated glaucoma.
Both eyes of the patient are treated: each eye is allocated in a group using the closed envelopes method. Both the patient and the surgeon who performs the post laser examinations are not aware of the group allocation.
The exams required before the trabeculoplasty are: best corrected visual acuity, IOP measurement, specular microscopy with corneal central thickness.
The IOP is measured an hour after MLT (micropulsed laser trabeculoplasty), then on day one, at one month, at three months and six months. Best corrected visual acuity and specular microscopy are repeated at three months.
Expected outcomes: to compare the IOP lowering effects between group one and two and to assess the safety of the procedure on the corneal endothelium.
Secondary outcomes: decrease the number of glaucoma medications applied by the patients.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Micropulsed laser trabeculoplasty
- 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.
Micropulsed laser trabeculoplastyProcedure or surgery
Trabeculoplasty
| Study group | Role | What they receive |
|---|---|---|
| 1500 mW | Experimental | 1500 mW of Power Receives: Procedure: Micropulsed laser trabeculoplasty |
| 1000 mW | Active comparator | Standard treatment, 1000 mW Receives: Procedure: Micropulsed laser trabeculoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP lowering effect
Using a tonometer, we will evaluate the difference in intraocular pressure between baseline and after the treatment. The values will be expressed in mmHg.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start20 Mar 2020
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Jun 2022 (estimated)
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.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Maria Cavallini, University of Modena and Reggio Emilia
- Investigators
- Mastropasqua Rodolfo, MD, Professor, Study director, Policlinico di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900142
- Sponsor's protocol ID
- 1152/2019/DISP/AOUMO
- Status last verified
- May 2021
- First submitted
- 19 Dec 2020
- Last updated
- 25 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micropulsed Laser Trabeculoplasty: a Randomized Double Blinded Clinical Trial Using Different Parameters
- ClinicalTrials.gov ID
- NCT04900142
- Acronym / sponsor ID
- 1152/2019/DISP/AOUMO
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Jun 2022 (estimated)
- First posted
- 25 May 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.
This randomized, double blinded, clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma. Group one is treated with 1500 mW of Power, Group two with 1000 mW. The other settings (300 micron of diameter, 300 ms of duration, 15% duty cycle) are the same for both groups, and the laser is applied for 360°.
The main outcome is to evaluate the IOP (IntraOcular Pressure) lowering effects of both treatments and the safety on the corneal endothelium.
Detailed description
This study is a randomized, double blinded, clinical trial. Eligibility criteria are: primary open angle glaucoma, pigmentary glaucoma and pseudoexfoliation glaucoma.
Exclusion criteria are: secondary glaucoma, previous glaucoma surgery (not including cataract surgery as a glaucoma surgery), uncooperative patients, corneal endothelial diseases (such as Fuchs dystrophy or cornea guttata) and severely decompensated glaucoma.
Both eyes of the patient are treated: each eye is allocated in a group using the closed envelopes method. Both the patient and the surgeon who performs the post laser examinations are not aware of the group allocation.
The exams required before the trabeculoplasty are: best corrected visual acuity, IOP measurement, specular microscopy with corneal central thickness.
The IOP is measured an hour after MLT (micropulsed laser trabeculoplasty), then on day one, at one month, at three months and six months. Best corrected visual acuity and specular microscopy are repeated at three months.
Expected outcomes: to compare the IOP lowering effects between group one and two and to assess the safety of the procedure on the corneal endothelium.
Secondary outcomes: decrease the number of glaucoma medications applied by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1500 mW | Experimental | Procedure: Micropulsed laser trabeculoplasty1500 mW of Power |
| 1000 mW | Active comparator | Procedure: Micropulsed laser trabeculoplastyStandard treatment, 1000 mW |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Primary open angle glaucoma
- Pigmentary glaucoma
- Pseudoexfoliative glaucoma
Key exclusion criteria (4 listed)
- Secondary glaucoma
- Previous glaucoma surgery
- Severely decompensated glaucoma
- Corneal endothelial disease
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 |
|---|---|---|
| Micropulsed laser trabeculoplastyTrabeculoplasty | Procedure or surgery | 1000 mW, 1500 mW |
Primary outcome
IOP lowering effect
Time frame: Up to six months
Using a tonometer, we will evaluate the difference in intraocular pressure between baseline and after the treatment. The values will be expressed in mmHg.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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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.
Mastropasqua Rodolfo, MD, Professor study director
Policlinico di Modena
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulsed laser trabeculoplasty in people with Glaucoma, Open-Angle, run by University of Modena and Reggio Emilia at 2 sites 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 3 inclusion and 4 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 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Contact Matteo Gironi, MD (0594225087, matteo.gironi@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP lowering effect (time frame: Up to six months). 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 25 May 2021.