MicroPulse TLT - UK Study (MPTLTUKS)

Imperial College Healthcare NHS Trust

Status: Not yet enrolling

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

Treatments: Device: Micropulse Transscleral laser therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05593354

21WE3716

Details and patient eligibility

About

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

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

250 participants in 1 patient group

MPTLT patients

Description:

All UK patients undergoing MPTLT

Treatment:

Device: Micropulse Transscleral laser therapy