EyeCee One preloaded intraocular lens: are patients with glaucoma more at risk?

Author:

Jones Ruth KORCID,Jong Joel Lee ZherORCID,Ramjiani Vipul,Tan Jennifer H Y

Abstract

ObjectiveThe Medicine and Healthcare products Regulatory Agency reported links of raised intraocular pressure (IOP) with recently implanted EyeCee One intraocular lens (IOL). This work investigates if glaucomatous eyes were more susceptible to these postoperative IOP rises and if they required more intensive management.MethodsRetrospective observational study of all phacoemulsification surgery with implanted EyeCee One IOL, performed between 1 October 2022 and 26 January 2023 inclusive.AnalysisA significant IOP elevation was defined as an IOP rise of 10 mm Hg or more from preoperative to maximal postoperative IOP reading. The management of all patients who had a significant IOP elevation was reviewed. Glaucoma/ocular hypertension cases were identified and analysed against non-glaucomatous eyes and statistical analysis performed.Results112 glaucoma and 671 non-glaucoma cases identified; 19.6% of the glaucoma cohort had a significant postoperative IOP rise compared with 8.9% of patients without glaucoma (OR 2.49 (95% CI 1.45 to 4.20) p=0.0014). In the glaucoma cohort, 12.5% had an increase in the number of topical IOP-lowering agents (mean increase 1.65±1.58), 6.3% required systemic treatment and 2.7% surgical intervention. In the non-glaucoma group, 3.3% required topical treatment (mean number of agents 0.88±1.34), 0.8% required systemic treatment and 0.2% surgical intervention.ConclusionThis study shows that during the time frame in question, patients with glaucoma or ocular hypertension who had an EyeCee One IOL were almost two and a half times more likely to have a postoperative rise of 10 mm Hg or more in IOP following routine cataract surgery, requiring more aggressive management.

Publisher

BMJ

Subject

Ophthalmology

Reference10 articles.

1. Eyecee one preloaded and eyecee one crystal preloaded Intraocular lenses (Iols): stop using immediately and quarantine all preloaded eyecee one lenses DSI/2023/001. Available: https://www.gov.uk/drug-device-alerts/eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-stop-using-immediately-and-quarantine-all-preloaded-eyecee-one-lenses-dsi-slash-2023-slash-001

2. NIDEK FSN – urgent field safety notice . Medicines and healthcare products regulatory agency. Available: https://mhra-gov.filecamp.com/s/d/MWjGnAVxprpOgwQl

3. MHRA, NPSA . National patient safety alert: NIDEK eyecee one preloaded and eyecee one crystal preloaded intraocular lenses (Iols): risk of increased intraocular pressure (NatPSA/2023/003/MHRA).. Available: https://www.gov.uk/drug-device-alerts/national-patient-safety-alert-nidek-eyecee-one-preloaded-and-eyecee-one-crystal-preloaded-intraocular-lenses-iols-risk-of-increased-intraocular-pressure-natpsa-slash-2023-slash-003-slash-mhra

4. Wang H , Jong JLZ , Chiu SJ , et al . Evaluation of raised intraocular pressure post eyecee one preloaded intraocular lenses implantation. Eye (Lond) 2023. doi:10.1038/s41433-023-02487-y

5. Early postoperative intraocular pressure elevation following cataract surgery;Grzybowski;Curr Opin Ophthalmol,2019

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