Glaucoma Clinical Trial
— MPTLTUKSOfficial title:
MicroPulse Transscleral Laser Therapy: A Prospective UK Study
NCT number | NCT05593354 |
Other study ID # | 21WE3716 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2023 |
Est. completion date | December 2025 |
This Prospective Interventional Study will assess the efficacy of MPTLT in the UK.
Status | Not yet recruiting |
Enrollment | 250 |
Est. completion date | December 2025 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust | IRIDEX Corporation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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