GlaucomaNCT05654493
Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients
An observational study of Glaucoma, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 30 Jun 2023
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects scheduled for a MP-TSCPC procedure at the Florida Mayo Clinic site.
Who may be able to join
- Diagnose of glaucoma
- Indication to be submitted to the procedure
Who cannot join
- Significant thinning of the sclera
- Current eye infection or inflammation
- Intraocular surgery performed less than 2 months prior to the enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study
The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients.
Read the detailed description
Patients will be submitted to MP-TSCPC throughout the year of 2020, according to parameters determined by the Principal Investigator and executed by the Principal Investigator, after signing the Consent Form and agreeing on having their data used for research purpose. Postsurgical follow up visits will be scheduled for 1 month, 3 months, 6 months and 12 months. Patients IOP, number of medications, visual acuity, visual field, iris color, retinal nerve fiber layer thickness on OCT and any complications (iritis, corneal edema, hyphema, vitreous hemorrhage, vision loss, cataract progression or hypotony maculopathy) will be measured by trained ophthalmic assistants supervised by the Principal Investigator and documented at each visit. Authorized Mayo Clinic personnel will perform chart reviews; using administrative data as designated by Dr. Dorairaj. The data will be statistically analyzed to illustrate the results and determine if the objectives and primary and secondary endpoints were achieved
- Conditions
- Glaucoma
- Being tested
- MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroPulse Transscleral Laser Therapy using revised P3 Delivery DeviceDevice
Also called MP-TLT
The MicroPulse G-Probe was applied to the superior and inferior hemispheres of the eye under varied treatment times and sweep numbers
| Study group | Role | What they receive |
|---|---|---|
| 240 Second Group | Receives 240 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps Receives: Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device | |
| 300 Second Group | Receives 300 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 10 sweeps Receives: Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device | |
| 200 Second Group | Receives 200 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps Receives: Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change In IOP
Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)
Measured: Baseline, 12 months post procedure
Secondary outcomes (6)
Number of anti-glaucoma medications
Number of anti-glaucoma medication drops
Measured: 12 months
Change in visual acuity
Change in visual acuity score
Measured: Baseline, 12 months post procedure
Change in cup-disc ratio
Ratio of the size of the optic cup to the optic disc
Measured: Baseline, 12 months post procedure
Change in visual field
Total area visible in peripheral vision when focused on a central point, reported in degrees
Measured: Baseline, 12 months post procedure
Change in iris color
Number of subjects to have a change in their iris color
Measured: Baseline, 12 months post procedure
Complications
Number of subjects to experience complications from the procedure
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 posted16 Dec 2022
- Study start18 Apr 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syril K. Dorairaj, Mayo Clinic
- Investigators
- Syril Dorairaj, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654493
- Sponsor's protocol ID
- 19-008815
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05654493
- Acronym / sponsor ID
- 19-008815
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Dec 2022 (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.
The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients.
Detailed description
Patients will be submitted to MP-TSCPC throughout the year of 2020, according to parameters determined by the Principal Investigator and executed by the Principal Investigator, after signing the Consent Form and agreeing on having their data used for research purpose. Postsurgical follow up visits will be scheduled for 1 month, 3 months, 6 months and 12 months. Patients IOP, number of medications, visual acuity, visual field, iris color, retinal nerve fiber layer thickness on OCT and any complications (iritis, corneal edema, hyphema, vitreous hemorrhage, vision loss, cataract progression or hypotony maculopathy) will be measured by trained ophthalmic assistants supervised by the Principal Investigator and documented at each visit. Authorized Mayo Clinic personnel will perform chart reviews; using administrative data as designated by Dr. Dorairaj. The data will be statistically analyzed to illustrate the results and determine if the objectives and primary and secondary endpoints were achieved
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 240 Second Group | – | Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery DeviceReceives 240 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps |
| 300 Second Group | – | Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery DeviceReceives 300 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 10 sweeps |
| 200 Second Group | – | Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery DeviceReceives 200 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects scheduled for a MP-TSCPC procedure at the Florida Mayo Clinic site.
Key inclusion criteria (2 listed)
- Diagnose of glaucoma
- Indication to be submitted to the procedure
Key exclusion criteria (3 listed)
- Significant thinning of the sclera
- Current eye infection or inflammation
- Intraocular surgery performed less than 2 months prior to the enrollment in the study
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 |
|---|---|---|
| MicroPulse Transscleral Laser Therapy using revised P3 Delivery DeviceAlso: MP-TLTThe MicroPulse G-Probe was applied to the superior and inferior hemispheres of the eye under varied treatment times and sweep numbers | Device | 200 Second Group, 240 Second Group, 300 Second Group |
Primary outcome
Change In IOP
Time frame: Baseline, 12 months post procedure
Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)
6 secondary outcomes
Number of anti-glaucoma medications
Time frame: 12 months
Change in visual acuity
Time frame: Baseline, 12 months post procedure
Change in cup-disc ratio
Time frame: Baseline, 12 months post procedure
Change in visual field
Time frame: Baseline, 12 months post procedure
Change in iris color
Time frame: Baseline, 12 months post procedure
Complications
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 19 Mar 2026.
- Mayo Clinic Clinical TrialsLink 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.
Syril Dorairaj, MBBS principal investigator
Mayo Clinic
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 Glaucoma, run by Mayo Clinic at 1 site in United States.
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 3 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 19 Mar 2026. 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 United States. 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?
Change In IOP (time frame: Baseline, 12 months post procedure). 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 Mar 2026.