NCT05593354

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

October 17, 2022

Last Update Submit

March 27, 2023

Conditions

GlaucomaGlaucoma EyeGlaucoma, Open-AngleGlaucoma SecondaryGlaucoma, Angle-ClosureGlaucoma, NeovascularGlaucoma TraumaticGlaucoma Uveitic

Keywords

GlaucomaMicropulseTransscleral laser therapyCyclophotocoagulation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

  • Change in visual field (VF) following treatment

    At the clinical visit closest to months 1, 3, 6, 12, 18, 24, 30 and 36

Other Outcomes (2)

  • Compilation of evidence for further NICE review

    3 years

  • Compliance with NICE recommendations

    3 years

Study Arms (1)

MPTLT patients

All UK patients undergoing MPTLT

Device: Micropulse Transscleral laser therapy

Interventions

Micropulse Transscleral laser therapyDEVICE

Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine

Also known as: Cyclophotocoagulation, IRIDEX Cyclo G6
MPTLT patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleGlaucoma, Angle-ClosureGlaucoma, Neovascular

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Philip A Bloom, MB ChB FRCOphth

    Imperial College Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip A Bloom, MB ChB FRCOphth

CONTACT

+44 7887 636202philip.bloom@nhs.net

Eduardo M Normando, MD PhD FEBO

CONTACT

+44 7519 572069e.normando@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 25, 2022

Study Start

May 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 28, 2023

Record last verified: 2023-03