GlaucomaMPTLTUKSNCT05593354
MicroPulse TLT - UK Study
An observational study of Glaucoma and Glaucoma Eye, run by Imperial College Healthcare NHS Trust.
Trial summary
This Prospective Interventional Study will assess the efficacy of MPTLT in the UK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle
- What is being tested?
- Micropulse Transscleral laser therapy
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to Dec 2025
- How long will I take part?
- 3 Years
- 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: UK patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist
Who may be able to join
- Patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist; this includes but is not limited to (a) need for lower IOP, (b) need for fewer medications based on side effects, poor compliance, adverse effect on lifestyle or (c) evidence of disease progression based on function or structure
- Risk of invasive surgical procedure deemed too high by patient or surgeon
- Aged 18 years or older
- The ability to understand and comply with the trial consent process and procedures
- Willingness to be part of a national registry
- Ability to attend for follow-up
- Ability to give informed consent, or consent given by relative or carer
Who cannot join
- Clinical situations where in the opinion of the investigator, the ocular surface may be compromised by probe contact, including severe ocular surface inflammation
- Inability to give informed consent
- Unwillingness to have clinical data stored in a secure electronic format
- Inability to comply with the study or follow-up procedures
Trial locations and contacts
No sites are listed yet.
About this study
Official title: MicroPulse Transscleral Laser Therapy: A Prospective UK Study
This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.
Read the detailed description
We are establishing a National Study of MPTLT procedures, co-ordinating with all UK treatment centres to capture prospectively, details of all MPTLT surgical procedure and outcomes. This will create a National UK Registry of MPTLT, allowing us to comply with NICE requirements while adding to the quality of evidence available to support this minimally invasive therapy.
- Conditions
- Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Angle-Closure, Glaucoma, Neovascular
- Being tested
- Micropulse Transscleral laser therapy
- Keywords
- Glaucoma, Micropulse, Transscleral laser therapy, Cyclophotocoagulation
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Angle-Closure, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse Transscleral laser therapyDevice
Also called Cyclophotocoagulation, IRIDEX Cyclo G6
Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine
| Study group | Role | What they receive |
|---|---|---|
| MPTLT patients | All UK patients undergoing MPTLT Receives: Device: Micropulse Transscleral laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intra-ocular pressure (IOP) following treatment
Change in mean IOP before and after treatment, measured in mmHg using Goldmann Applanation Tonometry
Measured: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in medication use following treatment
Change in mean number of glaucoma medications before and after treatment
Measured: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Secondary outcomes (2)
Change in Retinal Nerve Fibre Layer (RNFL) following treatment
RNFL thickness change, measured in micrometers using optical coherence tomography
Measured: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in visual field (VF) following treatment
Change in VF sensitivity, measured as mean deviation in dB units using computerised VF perimetry
Measured: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 May 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
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.
- 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
- 250 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- IRIDEX Corporation
- Responsible party
- Sponsor
- Investigators
- Philip A Bloom, MB ChB FRCOphth, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593354
- Sponsor's protocol ID
- 21WE3716
- Acronym
- MPTLTUKS
- Status last verified
- Mar 2023
- First submitted
- 17 Oct 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroPulse Transscleral Laser Therapy: A Prospective UK Study
- ClinicalTrials.gov ID
- NCT05593354
- Acronym / sponsor ID
- MPTLTUKS / 21WE3716
- Conditions
- Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Angle-Closure, Glaucoma, Neovascular
- Keywords
- Glaucoma, Micropulse, Transscleral laser therapy, Cyclophotocoagulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- IRIDEX Corporation
- Study start
- 1 May 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Oct 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.
This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.
Detailed description
We are establishing a National Study of MPTLT procedures, co-ordinating with all UK treatment centres to capture prospectively, details of all MPTLT surgical procedure and outcomes. This will create a National UK Registry of MPTLT, allowing us to comply with NICE requirements while adding to the quality of evidence available to support this minimally invasive therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPTLT patients | – | Device: Micropulse Transscleral laser therapyAll UK patients undergoing MPTLT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UK patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist
Key inclusion criteria (7 listed)
- Patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist; this includes but is not limited to (a) need for lower IOP, (b) need for fewer medications based on side effects, poor compliance, adverse effect on lifestyle or (c) evidence of disease progression based on function or structure
- Risk of invasive surgical procedure deemed too high by patient or surgeon
- Aged 18 years or older
- The ability to understand and comply with the trial consent process and procedures
- Willingness to be part of a national registry
Key exclusion criteria (4 listed)
- Clinical situations where in the opinion of the investigator, the ocular surface may be compromised by probe contact, including severe ocular surface inflammation
- Inability to give informed consent
- Unwillingness to have clinical data stored in a secure electronic format
- Inability to comply with the study or follow-up procedures
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 therapyAlso: Cyclophotocoagulation, IRIDEX Cyclo G6Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine | Device | MPTLT patients |
Primary outcome
Change in intra-ocular pressure (IOP) following treatment
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in mean IOP before and after treatment, measured in mmHg using Goldmann Applanation Tonometry
Change in medication use following treatment
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in mean number of glaucoma medications before and after treatment
2 secondary outcomes
Change in Retinal Nerve Fibre Layer (RNFL) following treatment
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Change in visual field (VF) following treatment
Time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Philip A Bloom, MB ChB FRCOphth principal investigator
Imperial College Healthcare NHS Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Glaucoma Eye, run by Imperial College Healthcare NHS Trust.
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 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 28 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip A Bloom, MB ChB FRCOphth (+44 7887 636202, philip.bloom@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intra-ocular pressure (IOP) following treatment (time frame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36). The study lists 2 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 28 Mar 2023.