MPTLTUKS: MicroPulse TLT - UK Study
Study Details
Study Description
Brief Summary
This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| MPTLT patients All UK patients undergoing MPTLT |
Device: Micropulse Transscleral laser therapy
Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in intra-ocular pressure (IOP) following treatment [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 [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
Secondary Outcome Measures
- Change in Retinal Nerve Fibre Layer (RNFL) following treatment [At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36]
RNFL thickness change, measured in micrometers using optical coherence tomography
- Change in visual field (VF) following treatment [At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36]
Change in VF sensitivity, measured as mean deviation in dB units using computerised VF perimetry
Other Outcome Measures
- Compilation of evidence for further NICE review [3 years]
To provide high quality evidence of treatment efficacy upon which to base a future review of the current NICE guidance, allowing subsequent treatments to be freely used in the UK, outside the context of research
- Compliance with NICE recommendations [3 years]
To allow continued use of MPTLT in the UK, whilst complying with NICE guidance, which currently recommends treatment only in the context of research
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Risk of invasive surgical procedure deemed too high by patient or surgeon
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Aged 18 years or older
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The ability to understand and comply with the trial consent process and procedures
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Willingness to be part of a national registry
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Ability to attend for follow-up
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Ability to give informed consent, or consent given by relative or carer
Exclusion Criteria:
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Clinical situations where in the opinion of the investigator, the ocular surface may be compromised by probe contact, including severe ocular surface inflammation
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Inability to give informed consent
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Unwillingness to have clinical data stored in a secure electronic format
-
Inability to comply with the study or follow-up procedures
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Imperial College Healthcare NHS Trust
- IRIDEX Corporation
Investigators
- Principal Investigator: Philip A Bloom, MB ChB FRCOphth, Imperial College Healthcare NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21WE3716