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ADVERSE EVENTS OF THE ARGUS II RETINAL PROSTHESIS: Incidence, Causes, and Best Practices for Managing and Preventing Conjunctival Erosion
- Source :
- RETINA, RETINA, Lippincott, Williams & Wilkins, 2020, 40 (2), pp.303-311. ⟨10.1097/iae.0000000000002394⟩
- Publication Year :
- 2020
- Publisher :
- HAL CCSD, 2020.
-
Abstract
- Purpose To analyze and provide an overview of the incidence, management, and prevention of conjunctival erosion in Argus II clinical trial subjects and postapproval patients. Methods This retrospective analysis followed the results of 274 patients treated with the Argus II Retinal Prosthesis System between June 2007 and November 2017, including 30 subjects from the US and European clinical trials, and 244 patients in the postapproval phase. Results were gathered for incidence of a serious adverse event, incidence of conjunctival erosion, occurrence sites, rates of erosion, and erosion timing. Results Overall, 60% of subjects in the clinical trial subjects versus 83% of patients in the postapproval phase did not experience device- or surgery-related serious adverse events. In the postapproval phase, conjunctival erosion had an incidence rate of 6.2% over 5 years and 11 months. In 55% of conjunctival erosion cases, erosion occurred in the inferotemporal quadrant, 25% in the superotemporal quadrant, and 20% in both. Sixty percent of the erosion events occurred in the first 15 months after implantation, and 85% within the first 2.5 years. Conclusion Reducing occurrence of conjunctival erosion in patients with the Argus II Retinal Prosthesis requires identification and minimization of risk factors before and during implantation. Implementing inverted sutures at the implant tabs, use of graft material at these locations as well as Mersilene rather than nylon sutures, and accurate Tenon's and conjunctiva closure are recommended for consideration in all patients.
- Subjects :
- Male
medicine.medical_specialty
conjunctival erosion
epiretinal implant
retinal prosthesis
Argus II
retinitis pigmentosa
Conjunctival Diseases
LEHA
Prosthesis Implantation
03 medical and health sciences
Quadrant (abdomen)
0302 clinical medicine
Postoperative Complications
Medicine
Humans
In patient
Adverse effect
Retrospective Studies
business.industry
Incidence (epidemiology)
Incidence
Settore MED/30 - MALATTIE APPARATO VISIVO
Retrospective cohort study
General Medicine
Middle Aged
United States
Surgery
Visual Prosthesis
Clinical trial
Europe
Ophthalmology
Retinal Prosthesis
030221 ophthalmology & optometry
Female
[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie
Implant
business
Conjunctiva
030217 neurology & neurosurgery
Subjects
Details
- Language :
- English
- ISSN :
- 0275004X
- Database :
- OpenAIRE
- Journal :
- RETINA, RETINA, Lippincott, Williams & Wilkins, 2020, 40 (2), pp.303-311. ⟨10.1097/iae.0000000000002394⟩
- Accession number :
- edsair.doi.dedup.....af9f31a31914ab7c22a7c1611319e84e
- Full Text :
- https://doi.org/10.1097/iae.0000000000002394⟩