MicroPulse TLT - UK Study

Not yet recruiting

• Conditions: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Glaucoma Traumatic; Glaucoma Eye; Glaucoma Secondary; Glaucoma Uveitic; Glaucoma, Neovascular
• Interventions: Device: Micropulse Transscleral laser therapy

• Registration Number: NCT05593354
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief Summary

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 Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28
• Study Start: 2023-05-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPTLT patients	Micropulse Transscleral laser therapy	All UK patients undergoing MPTLT

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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