MicroPulse TLT - UK Study

Glaucoma Clinical Trial

— MPTLTUKS  

Official title:

MicroPulse Transscleral Laser Therapy: A Prospective UK Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05593354
• Other study ID #: 21WE3716
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Imperial College Healthcare NHS Trust
• Contact: Philip A Bloom, MB ChB FRCOphth
• Phone: +44 7887 636202
• Email: philip.bloom[@]nhs.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye
• Glaucoma Secondary
• Glaucoma Traumatic
• Glaucoma, Angle-Closure
• Glaucoma, Neovascular
• Glaucoma, Open-Angle

Intervention

Device:
• Micropulse Transscleral laser therapy
Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust	IRIDEX Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Compliance with NICE recommendations	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
Primary	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
Primary	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	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
Secondary	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