Clinical trial NCT05593354: MicroPulse TLT - UK Study
Official title: MicroPulse Transscleral Laser Therapy: A Prospective UK Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Glaucoma
Glaucoma Eye
Glaucoma, Open-Angle
Glaucoma Secondary
Glaucoma, Angle-Closure
Glaucoma, Neovascular
Glaucoma Traumatic
Glaucoma Uveitic
Keywords: Glaucoma
Micropulse
Transscleral laser therapy
Cyclophotocoagulation
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: IRIDEX Corporation
First posted: 2022-10-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UK patients with glaucoma or ocular hypertension deemed clinically suitable for MPTLT treatment by their treating ophthalmologist

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in intra-ocular pressure (IOP) following treatment
timeFrame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
measure: Change in medication use following treatment
timeFrame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Secondary outcomes:
measure: Change in Retinal Nerve Fibre Layer (RNFL) following treatment
timeFrame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
measure: Change in visual field (VF) following treatment
timeFrame: At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36
Other outcomes:
measure: Compilation of evidence for further NICE review
timeFrame: 3 years
measure: Compliance with NICE recommendations
timeFrame: 3 years
Locations:
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Philip A Bloom, MB ChB FRCOphth
role: PRINCIPAL_INVESTIGATOR
References: