MicroPulse TLT - UK Study

Study Overview
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Brief Summary
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This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.

Detailed Description
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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.

Official Title
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MicroPulse Transscleral Laser Therapy: A Prospective UK Study

Conditions
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Glaucoma, Glaucoma Eye, Glaucoma, Open-Angle, Glaucoma Secondary, Glaucoma, Angle-Closure, Glaucoma, Neovascular, Glaucoma Traumatic, Glaucoma Uveitic

Intervention / Treatment
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* Device: Micropulse Transscleral laser therapy


Participation Criteria
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Eligibility Criteria
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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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MPTLT patients<br>All UK patients undergoing MPTLT | Device: Micropulse Transscleral laser therapy<br>* Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine<br>* Other names: IRIDEX Cyclo G6;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Micropulse, Transscleral laser therapy, Cyclophotocoagulation