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| Name | Class |
|---|---|
| IRIDEX Corporation | UNKNOWN |
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This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPTLT patients | All UK patients undergoing MPTLT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micropulse Transscleral laser therapy | Device | Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in intra-ocular pressure (IOP) following treatment | Change in mean IOP before and after treatment, measured in mmHg using Goldmann Applanation Tonometry | 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 | At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Retinal Nerve Fibre Layer (RNFL) following treatment | RNFL thickness change, measured in micrometers using optical coherence tomography | At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36 |
| Change in visual field (VF) following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Compilation of evidence for further NICE review | 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 | 3 years |
| Compliance with NICE recommendations |
Inclusion Criteria:
Exclusion Criteria:
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UK patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philip A Bloom, MB ChB FRCOphth | Contact | +44 7887 636202 | philip.bloom@nhs.net | |
| Eduardo M Normando, MD PhD FEBO | Contact | +44 7519 572069 | e.normando@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Philip A Bloom, MB ChB FRCOphth | Imperial College Healthcare NHS Trust | Principal Investigator |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D015812 | Glaucoma, Angle-Closure |
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Change in VF sensitivity, measured as mean deviation in dB units using computerised VF perimetry |
| At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36 |
To allow continued use of MPTLT in the UK, whilst complying with NICE guidance, which currently recommends treatment only in the context of research |
| 3 years |