Eyecee One Preloaded Intraocular Lens – Are Glaucoma And Ocular Hypertensive Patients More At Risk Of Significant Post Operative Rises In Intraocular Pressures?

The Medicine and Healthcare products Regulatory Agency (MHRA) issued a Device Safety Information notification on the 26th January 2023, actions to undertake immediately included, ceasing use and quarantining EyeCee One intraocular lens (EC1 IOLs) as there were reports of raised intraocular pressures (IOPs) in patients recently implanted with these lenses.  On the 1st February 2023 the MHRA issued a National Patient Safety Alert, recommending IOP checks to all patients who had received these implants since 1st October 2022, by the 16th February 2023. 

This work investigates if glaucomatous eyes are more susceptible to these postoperative IOP rises and if they required more aggressive management.  

A large public teaching hospital ophthalmology department in the UK, Sheffield Teaching Hospital NHS Trust.  Cataract surgery performed over two sites included, the Northern General Eye Unit, a dedicated cataract unit and the Royal Hallamshire Hospital.  

Retrospective analysis of all phacoemulsification surgery, performed between 1/10/22 and 26/1/23 inclusive, where a preloaded EC1 IOL was implanted.  Cases identified via electronic patient record (EPR). 

Combined cases that might influence post operative IOP, such as cataract with glaucoma or cataract with vitreoretinal procedures were excluded.   

A significant IOP elevation was defined as an IOP rise of 10mmHg or more from preoperative to maximal post operative IOP reading.  All patients which had a significant IOP elevation had their EPR reviewed and management of their raised post operative IOP was recorded. 

Glaucoma/Ocular hypertension cases were identified and analysed against non-glaucomatous eyes and statistical analysis performed.  

The study identified 112 glaucoma and 671 non glaucoma cases meeting inclusion/exclusion criteria. 

In the glaucoma cohort 19.64% had a significant post operative IOP rise compared to 8.94% of non-glaucoma patients, Odds Ratio 2.49 [95% CI, 1.45-4.20] p 0.0014. 

Management of the post operative IOP elevations, 12.5% of the glaucoma cohort had an increase in the number of topical IOP lowering agents, mean increase 1.65±1.58, 6.25% required systemic treatment and 2.68% surgical intervention.  The non-glaucoma group, 3.28% required topical treatment, mean number of agents 0.88±1.34, 0.75% required systemic treatment and 0.15% surgical intervention.  All differences between groups were statistically significant, except surgical intervention.  

Glaucoma patients are already at greater risk of field and visual impairment associated with IOP elevations following cataract surgery, especially if they already have documented optic nerve head changes with corresponding visual field impairment.  This study shows that during the time frame in question, patients with glaucoma or ocular hypertension who had an EC1 IOL implanted were almost two and a half times more likely to have a post operative rise of 10 mmHg or more in intraocular pressure following routine cataract surgery.  Also, this cohort required more aggressive management in all treatment domains, topical IOP lowering agents, systemic treatment and surgical intervention.