LONG-TERM CLINICAL SAFETY OF LASIK AND SURFACE ABLATION IN SOUTH KOREA THROUGH LINKAGE OF RETROSPECTIVE COHORT AND NATIONWIDE CLAIMS DATABASE
Author(s)
Lee EJ1, Choi JE1, Jung SY1, Jang EJ1, Lee NR1, Joo CK21National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, South Korea, 2Department of Ophthalmology and Visual Science, Catholic University College of Medicine, Seoul, South Korea
OBJECTIVES: To assess the long-term safety of Laser in situ keratomilieusis (LASIK) and surface ablation surgery for myopia in South Korea. METHODS: A retrospective cohort for patients who had a LASIK or surface ablation surgery in 6 hospitals during 2002-2005 were constructed based on chart reviews and linked to Health Insurance Review and Assessment (HIRA) claims database during 2005-2009. A total of 2,422 patients (4,688 eyes) were linked using anonymized identifier after excluding patients with a history of eye disease, diabetes, hyperopia, or different surgery methods for both eyes. The frequency of eye disease such as cataract, glaucoma, retinal detachment, corneal opacity, and keratoconus during 3-8 years after surgery and the pre-surgery characteristics including age, UCVA (uncorrected visual acuity), manifest refractive (MR) of patients with eye disease were analyzed. RESULTS: There were 1,637 LASIK patients and 785 surface ablation patients. The eye disease after LASIK were cataract (0.2%) and corneal opacity (0.9%) during 3-4 years and cataract (0.1%), glaucoma (0.2%), retinal detachment (0.4%) and corneal opacity (0.7%) during 4-5 years. The retinal detachment (0.3%) and corneal opacity (1.3%) were observed during 7-8 years while no keratoconus was identified during 3-8 year follow-up . The pre-surgery MR (mean±SD) were -6.98±1.41 Diopter (D), -7.46±2.87 D, -6.13±2.67 D, -6.23±2.62 D in patients with cataract, glaucoma, retinal detachment, and corneal opacity, respectively. The incidence of eye disease after surface ablation was similar to LASIK. CONCLUSIONS: The linkage of clinical baseline database and nationwide claims database can make up for loss to follow-up in retrospective cohort study. Although it is difficult to explain the causality of surgery, we could ascertain there was no serious eye disease after surgery.
Conference/Value in Health Info
2011-05, ISPOR 2011, Baltimore, MD, USA
Value in Health, Vol. 14, No. 3 (May 2011)
Code
PSU5
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Sensory System Disorders