MicroPulse TLT - UK Study

NCT ID: NCT05593354

Last Updated: 2023-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MPTLT patients

All UK patients undergoing MPTLT

Micropulse Transscleral laser therapy

Intervention Type DEVICE

Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine

Interventions

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Micropulse Transscleral laser therapy

Transscleral laser cyclophotocoagulation using the IRIDEX Cyclo G6 machine

Intervention Type DEVICE

Other Intervention Names

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Cyclophotocoagulation IRIDEX Cyclo G6

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRIDEX Corporation

UNKNOWN

Sponsor Role collaborator

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philip A Bloom, MB ChB FRCOphth

Role: PRINCIPAL_INVESTIGATOR

Imperial College Healthcare NHS Trust

Central Contacts

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Philip A Bloom, MB ChB FRCOphth

Role: CONTACT

+44 7887 636202

Eduardo M Normando, MD PhD FEBO

Role: CONTACT

+44 7519 572069

Other Identifiers

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21WE3716

Identifier Type: -

Identifier Source: org_study_id

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