Safety and complications of more than 1500 small-incision lenticule extraction procedures.
Ophthalmology
; 121(4): 822-8, 2014 Apr.
Article
em En
| MEDLINE
| ID: mdl-24365175
ABSTRACT
PURPOSE:
To evaluate the safety and complications of small-incision lenticule extraction (SMILE).DESIGN:
Clinical control cohort study.PARTICIPANTS:
A total of 922 healthy patients (1800 eyes) who were treated for myopia or myopic astigmatism between January 2011 and March 2013 at the Department of Ophthalmology, Aarhus, Denmark.METHODS:
Patients received a full preoperative examination and were treated with SMILE in both eyes and followed for 3 months (1574 eyes). Patients with complications, including loss of corrected distance visual acuity (CDVA) or dissatisfaction, were offered a late reexamination. MAIN OUTCOMEMEASURES:
Surgical complications and CDVA.RESULTS:
Mean preoperative spherical equivalent refraction was -7.25±1.84 diopters (D). Average postoperative refraction was -0.28±0.52 D, and mean error of treatment was -0.15±0.50 D. By 3 months, 86% (1346 eyes) had unchanged or improved CDVA. A loss of 2 or more lines was observed in 1.5% of eyes; however, at a late follow-up visit (average, 18 months), CDVA was within 1 line of the preoperative level in all eyes. Perioperative complications included epithelial abrasions (6%), small tears at the incision (1.8%), and difficult lenticule extraction (1.9%). The cap was perforated in 4 eyes, and a major tear occurred in 1 eye; however, none of these patients had late visual symptoms. In 0.8% (14 eyes), suction was lost during surgery. Re-treatment was successful in 13 eyes, whereas 1 eye had ghost images and was re-treated with topography-guided photorefractive keratectomy (PRK). Postoperative complications included trace haze (8%), epithelial dryness on day 1 (5%), interface inflammation secondary to central abrasion (0.3%), and minor interface infiltrates (0.3%); these complications had an impact on CDVA at 3 months in only 1 case. Irregular corneal topography occurred in 1.0% of eyes, resulting in reduced 3-month CDVA (12 eyes) or ghost images (6 eyes). Topography-guided PRK was performed in 4 eyes, with improvement in 3 cases. Satisfaction was high, with only 2 patients dissatisfied at their latest visit because of blurred vision or residual astigmatism.CONCLUSIONS:
Overall, SMILE had acceptable safety. Although 1.5% of eyes had reduced CDVA by 3 months, visual acuity was restored in the long term. Likewise, patient satisfaction was high.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Complicações Pós-Operatórias
/
Astigmatismo
/
Substância Própria
/
Cirurgia da Córnea a Laser
/
Lasers de Excimer
/
Miopia
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Incidence_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article