MicroPulse TLT - UK Study (MPTLTUKS)

MicroPulse Transscleral Laser Therapy: A Prospective UK Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Glaucoma, Neovascular; Glaucoma Eye; Glaucoma Secondary; Glaucoma Traumatic; Glaucoma Uveitic
• Intervention / Treatment: Device: Micropulse Transscleral laser therapy

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Philip A Bloom, MB ChB FRCOphth; Phone Number: +44 7887 636202; Email: philip.bloom@nhs.net
• Study Contact Backup: Name: Eduardo M Normando, MD PhD FEBO; Phone Number: +44 7519 572069; Email: e.normando@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

UK patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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: Cyclophotocoagulation; IRIDEX Cyclo G6

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Imperial College Healthcare NHS Trust
• Collaborators: IRIDEX Corporation
• Investigators: Principal Investigator: Philip A Bloom, MB ChB FRCOphth, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: October 20, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Glaucoma; Cyclophotocoagulation; Micropulse; Transscleral laser therapy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular; Glaucoma, Angle-Closure
• Other Study ID Numbers: 21WE3716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes