Forward Vision:
Delaying thesilent theft ofsight

Improving glaucoma outcomesand patients’ quality of life

APRIL 2023 | POST-ROUNDTABLE REPORTGLAUCOMA PARLIAMENTARYROUNDTABLE 2023

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TABLE OF CONTENTS
1. EXECUTIVE SUMMARY.............................................03
2. WHAT IS GLAUCOMA? ............................................04
a. Relationship between cataracts and glaucoma
3. WHAT IS THE CURRENT PROBLEM?..........................05
a. Patient backlog
b. Patient impact
c. Medical adherenced. Systemic inequity
e. Slow adoption of technology
f. Objectives of the roundtable
4. DISCUSSION POINTS ..............................................08
a. iStent inject®
b. System equity
c. Clear need for alternative glaucoma treatment
d. The solution: ISTC Pilot
e. Device selection
f. Patient selection
g. Clinician experience and training
h. System collaboration and next steps
5. RECOMMENDATIONS..............................................13
a. An iStent inject® pilot with an ISTC
b. Patient criteriac. Patient pathway
d. Make dual procedures standard across the devolved
nations
6. REFERENCES..........................................................14

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EXECUTIVE SUMMARYAs the health system in the UK grapples with aiming to provide highstandard and adequate care while managing significant patient
backlogs, inequalities within the system arise. Access to medical
devices, which are essential for improving patient outcomes, is often
inconsistent for both patients and practitioners. This divergence
between the treatments available from the NHS and at independent
sector treatment centres (ISTCs) can lead to lost opportunities toachieve the best patient outcome.
With eye care accounting for nearly 10% of backlogs in the healthcare
system, glaucoma has arisen as an area in urgent need of reform andimprovement. The Glaucoma Parliamentary Roundtable was held in
February 2023, which offered an opportunity for leading practitioners
and industry professionals to examine the current standard of care forglaucoma and where it can be improved.
Currently, eye drops are the standard glaucoma-management option,
but participants agreed that their effectiveness and the consistency of
their use is too poor for many patients to manage their glaucoma
successfully. Participants agreed that medical devices, like the iStent
inject®, were safe and effective at mitigating the disease and that, withmany patients suffering from glaucoma and cataracts at the same time,
opportunities to tackle both diseases in one combined surgicalintervention were frequently being missed in ISTCs.
It was decided that – whilst complying with strict measures to ensure
patient safety and choice – a pilot should be set up to trial the use ofsuch a device within ISTC ophthalmic settings, bringing their treatment
options in line with in-house NHS provision. This trial would help
demonstrate the value of combined procedures to the health service
and to the patient.

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WHAT IS GLAUCOMA?
Glaucoma is a chronic, progressive eye disease caused by damage tothe optic nerve, which leads to visual field loss. Affecting around
480,000 people in England alone (NHS Digital, 2023), the condition
develops as a result of fluid build up in the front part of the eye,increasing internal pressure leading to a loss of vision.
In its early stages, glaucoma is a symptomless disease and candamage sight and cause sight loss before it is detected. Those mostat risk of developing Glaucoma are:People with high internal eye pressure, also known as
intraocular pressure
Aged over 55
Those from Black, Asian or Hispanic heritage
Those with certain medical conditions, such as diabetes,
migraines, high blood pressure and sickle cell anaemia
Those with corneas which are thin in the centre
People with eye injury
Those taking corticosteroid medicines (e.g. eye drops) for along time
Relationship between glaucoma and cataracts
Whilst glaucoma and cataracts are not typically related, the risk
factors for both eye conditions can worsen or develop with age.
Cataract surgery is the most common elective procedure
performed in the NHS (The Royal College of Ophthalmologists,2022), and many cataract patients also suffer from glaucoma(Glaucoma Associates of Texas, 2023).

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WHAT IS THE CURRENT PROBLEM?
Patient backlog
Ophthalmology services have long been overlooked and are in clear needof transformative support to prevent patients losing their sight,
particularly with the Public Accounts Committee reporting that NHS
England (NHSE) is expected to miss its Elective Recovery Targets (Public
Accounts Committee, 2023).
During 2020, there was a 66% reduction in referrals for glaucoma into
hospitals in England (Specsavers, 2022). This has resulted in a significant
number of patients not being seen at the time and now – three years on –requiring further treatment within the NHS, with glaucoma waiting lists
specifically cited as the longest they have ever been (Specsavers, 2022).
Now, ophthalmology accounts for 10% of the NHS backlog (Optometry
Today, 2022) and is only expected to increase as someone is diagnosed
with sight loss every six minutes (Fight for Sight, 2022). In a recent study,
72% of optometrists reported that they have seen a patient in the last six
months who had experienced a delay to treatment of 12 months or more,while 43% had concerns about patients losing their sight unnecessarily(The Guardian, 2023).
Patient impact
Referred to as the ‘silent thief of sight’, the gradual and incremental
progression of glaucoma, combined with prolonged waiting times fortreatment, exacerbates patients’ existing concerns over their health andfuture, often contributing to significant mental health concerns. Patients
have spoken about their fear of losing their sight, job and ability to live
their lives as normally as they had before being diagnosed with glaucoma.
These fears are heightened by the risk of injury and other health issues
resulting from their sight loss.
Alongside this emotional burden, there is a significant economic burden
associated with poor eye health. It is currently estimated that the cost ofblindness will be £33.5 billion by 2050 (Fight for Sight, 2020).

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Slow adoption of technology
Despite the commitment from the NHS and Government in buildinga resilient healthcare system, there are significant barriers facing the
adoption of innovative technologies. NHS England and NHS
Improvement (NHSE&I) estimate that it takes 17 years on average(DHSC, 2020) for a new product or device to go from the clinical
trial stage to mainstream adoption. Currently, companies typicallyhave to engage and convince several layers of decision-makers
within providers and each trust to get products adopted, resulting insome patients having access to innovative technologies in one area
and others receiving a different quality of care.

Medical adherence
Currently, the main treatment for glaucoma is prescription eye
drops, which lower the pressure in the eye and, thereby, prevent
damage to the optic nerve (National Eye Institute, 2021). A lack ofcompliance with the prescription has been proven to accelerate theprogression of the disease, while strict adherence has the opposite
effect. However, the difficulty of self-administration, requiring acertain level of consistent timing and organisation, is something thatpatients often find too complicated. This results in critically low
adherence levels, which in turn further disrupts a patient’s lifestyle as
their sight continually declines.
At times, the drops can have significant side effects – ocular surface
irritation can occur as a result of the preservatives in the drops,
causing patients significant discomfort, red eyes and blurred vision.
Other side effects can include changes to eye colour, low bloodpressure, reduced pulse rate, and fatigue. Long-term use of eyedrops can also cause corneal surface damage and promote ocularsurface disease.

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Systemic inequity
Currently, glaucoma treatment is predominantly taken care of by the
NHS, while cataract surgery is often outsourced to ISTCs, which havethe capacity to treat patients more quickly, with the aim of reducing
backlogs in NHS care. However, while patients in three-quarters of
NHS hospitals have access to revolutionary treatments such as theiStent inject®, patients at ISTCs do not. This means that the majorityof the cataract patients in England are unable to benefit from lifechanging technologies.
The Royal College of Ophthalmologists (Royal College ofOphthalmologists, 2021) has highlighted the need to improve patient
safety and quality of service for patients being treated in the
independent sector, allowing them to receive the same equity of careas provided within the NHS.

Objectives of the roundtable
There is a clear case for providing safe, effective, efficient andinnovative treatment to transform glaucoma care across England andthe health system, to help prevent avoidable sight loss. There is nolonger a reason for glaucoma and cataract surgeries to be conducted
as two separate procedures. Combined procedures can provide
further efficiency to treat both cataract and glaucoma at the sametime, for patients who have been diagnosed with both diseases,
rather than four separate surgeries at different times.
We wanted to bring stakeholders across the entire patient pathway
and health system to discuss how best to improve glaucoma
outcomes, patient care and drive equity of care across the system,
whilst also supporting the NHS in its ambitious elective recovery
plan.

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DISCUSSION POINTS

iStent inject®
The iStent inject® is the smallest implantable device inthe human body (Glaukos, 2023 a, b). Studies haveshown that it improves drainage and lowers eye
pressure, which has been proven to reduce the risk of
future sight loss and prevent the need for further
invasive glaucoma treatment.
Over one million iStent technology implants have beendelivered worldwide, with 25,000 in Englandspecifically – with a decade of real-world evidence, thedevice can be seamlessly implemented into the ISTCs’
treatment procedures, adding only a few minutes onto
routine cataract surgery.
The ophthalmologists at the roundtable felt that the
implantation of iStent inject® during cataract surgery
was an obvious solution as it is the least complicatedprocedure, they said that it was time-efficient, led to a
reduction of medication and better pressure control,and 60-70% of patients operated on needed further
treatment.

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System equity
ISTCs are currently performing about 50% of the cataract proceduresin the UK (Royal College of Ophthalmologists, 2021) but they do nothave access to iStent inject®. This causes a patient choice issue
where patients can either go to an ISTC with a limited waiting list but
no opportunity for combined cataract and glaucoma treatment, or an
NHS treatment centre with combined procedures but a longer
waiting list. If they choose to go to an ISTC for cataract procedure,
they then remain on the NHS waiting list for later glaucoma
treatment — creating patient inequality and lack of efficiency forelective recovery. There is also a need to ensure that those referring
patients for treatment are aware of the new treatment options within
the NHS and have the information available to have a fully-informed
discussion with the patient, prior to referral.
Around 27,000 people are waiting 52 weeks for ophthalmology
treatment at the time of writing (The Guardian, 2023). While the NHS
is struggling to overcome the elective backlog, patients will belimited in their ability to have combined procedures.
Through ISTCs providing combined procedures, there is an
opportunity for all providers to deliver the same standard of care andpatients being seen in the same time frame to prevent further sightloss.

Clear need for alternative glaucoma treatment
The greatest issue with current treatment options is medical
adherence with eye drops. Patients find them confusing and invasive.
Those at the roundtable noted that the biggest point of use of apatient group helpline is calls around difficulty with eye drops.
Patients' quality of life would be significantly increased if theirreliance on eye drops was reduced or even removed.

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The solution: ISTC Pilot
Once the discussion on the challenges concluded, it wasrecommended to commence a pilot of combined procedures at an
ISTC. The aim of this pilot would be to highlight the value of iStent
inject® for patient outcomes and demonstrate that this procedure
can work within the ISTCs and improve the patient waiting list. All
ISTCs present acknowledged the value that the pilot could bring toglaucoma services and that if combined procedures were not scaled
up soon, there would continue to be systematic patient inequity forthe foreseeable future.
To be able to effectively set the standard of care and change
behaviour across the system, it was agreed that this pilot would need
to be delivered to focus on patient outcomes, device safety and costeffectiveness. It was also agreed that it should be peer-reviewed andcoupled with a patient impact assessment to understand the patient
voice in the proposed new pathway.

"The iStent inject® is a remarkable device. It is thesmallest device implantable into the human body,yet has a significant impact on improving
patient's experience, and thus quality of care."- Imran Masood

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Patient selection
Throughout the pilot, it will be important to formulate clear andconcise criteria for which patients will be eligible for combined
procedures, ensuring patient voice and a choice of procedures when
they are being referred for treatment. Whilst the vast majority of
individuals will come in for cataract surgery, not every patient who
has glaucoma will have cataracts and not every cataract patient will
have glaucoma.
It is important to define a clear set of standards with optometrists and
NHS trusts about when a patient should be offered the combined
procedure as part of the trial.
Device selection
To remain impartial, the attendees discussed and considered thetype of device that would be suitable to be scaled up within such a
trial. There are several currently on the market with differing levels ofevidence, efficacy and use. It was agreed that its safety profile wasparamount to avoid patients returning back to the NHS.
After discussion, it was referenced that iStent inject® has the highest
safety profile of any of the MIGS procedures and was rarely going tocreate a serious complication for the patient and deemed the mostsuitable device for the pilot.
Clinician experience and training
Patient safety was central to this discussion and to the delivery ofcare within the health system. It will be important to ensure thatclinicians offering the dual procedure will have had proficient training
for iStent inject®.
All those at the roundtable agreed that there should be a minimum
number of years’ experience required for those operating, to ensure
the results of the pilot are as positive for the patient as possible.

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System collaboration and next steps
As this pilot will include multiple referral points – such as community
optometrists, NHS specialists and the ISTCs – it is vital that diagnosis,
referral and follow-up routes are clarified from the beginning toensure that no patient falls through the cracks.
Additionally, it is important that this is considered properly in relation
to patient safety and optometrists’ capacity, particularly when apatient is moving back into the NHS post-surgery. If timelines androutes are unclear, there is a risk of optometrists being overwhelmedwith check-in appointments, or patients waiting too long to be seen.
It was positive to see a commitment for true partnership working
between ISTCs and NHS to understand how this can be implemented
and to deliver the best care for patients.

"I would say that anyone with real eye pressure
problems should seriously consider having this[combined cataract / iStent inject® procedure] asthey can have both of these issues attended to at
the same time."- Ollie Oliveria, iStent patientGLAUCOMA PARLIAMENTARYROUNDTABLE 2023

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RECOMMENDATIONS
An iStent inject® pilot with an ISTC
It was decided that a pilot scheme with iStent inject® would
demonstrate the value of combined procedures for cataract andglaucoma treatment to the health services (through significant
reductions in the need for further surgery by performing a combined
procedure) and to patients (in their quality of life, sight-retention,and the opportunity to undergo a single operation which addresses
both their cataracts and glaucoma).
The structure and location of the pilot will be decided during further
detailed conversations.

Patient criteria
The pilot should only include patients on a strict medical-need basis,
acknowledging that there is not a one-size-fits all solution. The
criteria for patients should be decided with the optometrists and
NHS specialists who are already engaging with these patients in theexisting pathway.
Patient pathway
The pilot needs to consider the whole patient pathway and make theright choice for the patient. There needs to be joined-up discussions
with optometrists, NHS trusts, ophthalmologists and ISTCs to ensurethat the criteria and responsibility across the entire patient pathway
is clear and well-communicated and documented.

Make dual procedures standard across the devolved nations
The participants acknowledged the four UK health systems, andrecommended that inequality of care challenges should be tackled in
all parts of the United Kingdom, not just England.

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REFERENCES
1. NHS Digital, 2023
2. The Royal College of Ophthalmologists, 2022
3. Glaucoma Associates of Texas, 2023
4. Public Accounts Committee, 2023
5. Specsavers, 2022
6. Optomotry Today, 2022
7. Fight for Sight, 2022
8. DHSC, 2020
9. National Eye Institute, 2021
10. The Guardian, 2023
11. Fight for Sight, 2020
12. The Royal College of Ophthalmologists, 2021
13. Glaukos, 2023a
14. Glaukos, 2023b

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INDICATION FOR USE: The iStent inject® , is intended to reduce intraocular pressure safely andeffectively in patients diagnosed with primary open-angle glaucoma, pseudo-exfoliative glaucoma or
pigmentary glaucoma. The iStent inject® , can deliver two (2) stents on a single pass, through a single
incision. The implant is designed to stent open a passage through the trabecular meshwork to allow for
an increase in the facility of outflow and a subsequent reduction in intraocular pressure. The device issafe and effective when implanted in combination with cataract surgery in those subjects who require
intraocular pressure reduction and/or would benefit from glaucoma medication reduction. The device may
also be implanted in patients who continue to have elevated intraocular pressure despite prior treatment
with glaucoma medications and conventional glaucoma surgery. CONTRAINDICATIONS: The iStent inject®
System is contraindicated under the following circumstances or conditions: • In eyes with primary angle
closure glaucoma, or secondary angle-closure glaucoma, including neovascular glaucoma, because thedevice would not be expected to work in such situations. • In patients with retrobulbar tumor, thyroid eye
disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleralvenous pressure. WARNINGS/PRECAUTIONS: • For prescription use only. • This device has not beenstudied in patients with uveitic glaucoma. • Do not use the device if the Tyvek® lid has been opened or
the packaging appears damaged. In such cases, the sterility of the device may be compromised. • Due tothe sharpness of certain injector components (i.e. the insertion sleeve and trocar), care should be
exercised to grasp the injector body. Dispose of device in a sharps container. • iStent inject® is MRConditional; see MRI Information below. • Physician training is required prior to use of the iStent inject®
System. • Do not re-use the stent(s) or injector, as this may result in infection and/or intraocularinflammation, as well as occurrence of potential postoperative adverse events as shown below under“Potential Complications.” • There are no known compatibility issues with the iStent inject® and otherintraoperative devices. (e.g., viscoelastics) or glaucoma medications. • Unused product & packaging may
be disposed of in accordance with facility procedures. Implanted medical devices and contaminatedproducts must be disposed of as medical waste. • The surgeon should monitor the patient postoperatively
for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after
surgery, the surgeon should consider an appropriate treatment regimen to reduce intraocular pressure. •Patients should be informed that placement of the stents, without concomitant cataract surgery in phakic
patients, can enhance the formation or progression of cataract. ADVERSE EVENTS: Please refer to
Directions For Use for additional adverse event information. CAUTION: Please reference the Directions
For Use labelling for a complete list of contraindications, warnings and adverse events.
© 2023 Glaukos Corporation.
All rights reserved. Glaukos, iStent®, iStent inject® are registeredtrademarks of Glaukos Corporation. PM-UK-0071