In partnership with the Imperial College Healthcare National Health Service (NHS) Trust, Iridex Corporation has enrolled the first patient in a study assessing the use of Iridex’s MicroPulse Transscleral Laser Therapy (MP-TLT) with its Cyclo G6 Laser and MicroPulse P3 delivery device for glaucoma.
Give me a rundown on this UK organization.
Formed in 2007 and based in London, United Kingdom, the Imperial College Healthcare NHS Trust consists of five hospitals across northwest London that provide over 200 clinical services for 1+ million patients.
On the research front, the trust conducts hundreds of clinical trials along with other studies each year as well as research into common diseases considered as global health challenges.
Gotcha. Now a refresher on these technologies.
Part of Iridex’s probe delivery device products, the Iridex Cyclo G6 laser is a semiconductor diode laser designed to deliver true continuous wave infrared (810 nm) laser light for ophthalmic applications.
The MicroPulse P3, on the other hand, is a single-use, RFID, fiber-optic handheld delivery device. When used with the Cyclo G6, the device transmits 810 nm MicroPulse laser energy “transsclerally to the ciliary processes to treat glaucoma.”
And this MicroPulse TLT process?
MP-TLT is a non-incisional laser procedure performed using the Iridex Cyclo G6 laser (in the micropulse treatment mode) with the MicroPulse P3 probe to treat cases where there is a diagnosis of:
- Primary open-angle glaucoma (POAG)
- Secondary open-angle glaucoma
- Closed-angle glaucoma
- Refractory glaucoma
The technology delivers repetitive and short “on” pulses that are followed by longer “off” periods in order to control increasing temperatures and prevent thermal buildup in the tissue—delivering an intended effect to targeted tissue.
What’s the purpose?
MP-TLT is intended to provide a significant lowering of intraocular pressure (IOP), allowing for its use in a broader range of glaucoma patients.
Side note: In the U.S., Iridex recently launched its next-gen PAttern SCAnning Laser (PASCAL) platform with MicroPulse, designed as an advanced technology package of fast / precise pattern scanning capabilities and three tissue-sparing technologies in a smaller, ergonomically-optimized integrated laser platform
So what’s the intent of this collaboration?
Per the announcement, the partnership is intended to establish “a large-scale enrollment platform to advance clinical research,” through the joint medical research study and registry.
Gotcha. Now explain this study.
The “MicroPulse Transscleral Laser Therapy: A Prospective UK Study” (MPTLTUKS) (NCT05593354) is a prospective, interventional 3-year trial.
The purpose: to assess the efficacy of MP-TLT in the UK via details of all MP-TLT procedures and outcomes.
The goal: to create a National UK Registry of MP-TLT that complies with NICE (National Institute for Health and Care Excellence) requirements (the country’s evidence-based recommendations for health and care) while also adding peer-reviewed evidence-based data to support the treatment.
Talk details.
The study is looking to enroll an estimated 250 participants (age 18+) diagnosed with glaucoma or ocular hypertension (OHT) and deemed clinically suitable for MP-TLT treatment.
All patients will undergo MP-TLT (cyclophotocoagulation) via the Iridex Cyclo G6 and be followed for a 3-year period.
What’s being measured?
A total of four outcome measures:
- Primary: measured at months 1, 3, 6, 12, 18, 24, 30, and 36
- Change in intraocular pressure (IOP) after treatment
- Change in glaucoma medication use after treatment
- Secondary: measured at months 1, 3, 6, 12, 18, 24, 30, and 36
- Change in retinal nerve fiber layer (RNFL) after treatment
- Change in visual field (VF) sensitivity
- Other: measured at 3 years
- Evidence compilation for further NICE review
- Compliance with NICE recommendations
What’s notable about this design?
Both the registry and study are structured to enable other UK providers to participate in the program and, as a result, build enrollment for larger patient cohorts, according to Iridex.
“Expansion to include other units will be crucial in advancing glaucoma treatment,” according to Philip Bloom, MB ChB FRCS (Ed) FRCOphth, consultant ophthalmic surgeon at the Imperial College Healthcare NHS Trust.
Gotcha. And when can we expect data?
Per Clinical Trials, the study is expected to conclude by December 2025. Stay tuned though, as data may be released in the interim.
Significance?
"The first patient enrollment in this partnership… is the first step toward multicenter participation enabling a large-scale view and significant in-country impact of our MicroPulse technology,” stated David I. Bruce, Iridex president and CEO.