The CLAO journal : official publication of the Contact Lens Association of Ophthalmologists, Inc · 2002
Retrospective safety study of the herrick lacrimal plug: a device used to occlude the lacrimal canaliculus.
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Jones Clarence E, Anklesaria Manek, Gordon Alan D, Prouty Robert E, Rashid Richard, Singla Raj K, Schachet John L
Аннотация
PURPOSE: The purpose of this study was to evaluate the safety of the Herrick Lacrimal Plug (HLP) (Lacrimedics, Eastsound, WA) by reviewing medical records obtained from patients in whom the HLP was implanted.
METHODS: A total of 228, primarily dry-eye, patients who had received one or more HLP implants at 19 centers during 1994 were included in the review; both centers and patients were randomly selected for inclusion. Medical records were examined for evidence of adverse events, which were characterized by presumed relationship to treatment, time of occurrence, severity, treatment required, and clinical outcome. Patients were contacted by phone whenever possible to verify the accuracy of the information extracted from their medical records.
RESULTS: A total of 35 adverse events likely, or definitively related to treatment, were recorded for 25 (11.0%) of 227 evaluable patients who were followed for 0 to 4.6 years (mean, 0.9 years). The most common adverse event was epiphora (21), followed by plug displacement (7), ocular irritation (5), ocular pain (1), and headache (1). Sixteen (7.0%) patients (15 epiphora, 1 headache) had one or more plugs removed using a perfusion technique, with symptoms resolving for 13 patients, reduced for one but persisting for the remaining two. None of the baseline or treatment variables were found to be predictors of the occurrence of an adverse event following plug implantation.
DISCUSSION: Approximately 10% of the patients who underwent implantation with the HLP in this series presented with a device-related adverse event, most commonly epiphora, which usually resolved following plug removal with a saline perfusion method. For the two patients (0.9%) whose epiphora did not resolve following plug removal, both had the same symptom before plug implantation, so it is unclear if persistence was the result of plug retention in the lacrimal drainage system or merely continuation of a preexisting condition.
METHODS: A total of 228, primarily dry-eye, patients who had received one or more HLP implants at 19 centers during 1994 were included in the review; both centers and patients were randomly selected for inclusion. Medical records were examined for evidence of adverse events, which were characterized by presumed relationship to treatment, time of occurrence, severity, treatment required, and clinical outcome. Patients were contacted by phone whenever possible to verify the accuracy of the information extracted from their medical records.
RESULTS: A total of 35 adverse events likely, or definitively related to treatment, were recorded for 25 (11.0%) of 227 evaluable patients who were followed for 0 to 4.6 years (mean, 0.9 years). The most common adverse event was epiphora (21), followed by plug displacement (7), ocular irritation (5), ocular pain (1), and headache (1). Sixteen (7.0%) patients (15 epiphora, 1 headache) had one or more plugs removed using a perfusion technique, with symptoms resolving for 13 patients, reduced for one but persisting for the remaining two. None of the baseline or treatment variables were found to be predictors of the occurrence of an adverse event following plug implantation.
DISCUSSION: Approximately 10% of the patients who underwent implantation with the HLP in this series presented with a device-related adverse event, most commonly epiphora, which usually resolved following plug removal with a saline perfusion method. For the two patients (0.9%) whose epiphora did not resolve following plug removal, both had the same symptom before plug implantation, so it is unclear if persistence was the result of plug retention in the lacrimal drainage system or merely continuation of a preexisting condition.