The numbers, efficacy, predictability and safety of laser refractive surgery procedures are shown in Figures 9.1 to 9.4.
A total of 64,932 laser refractive surgery procedures were performed at SNEC from 1992 to 2014.
Over the past 10 years, nearly 100% of patients achieved an unaided visual acuity of 6/12 or better after laser refractive surgery procedures.
Since 2010, predictability has been consistently greater than 95% at SNEC.
The complication rates of post-refractive surgery have been consistently low, at <3%, over the audit period (1998 to 2014). Over the last five years of audit, the complication rates decreased further to 0.1 to 0.45%.
In 2014, LASIK procedures were performed and audited in 1,276 eyes from 645 patients. 99.3% of eye achieved unaided visual acuity of 6/12 or better and 79.7% of eyes achieved that of 6/6 or better. 98.6% of eyes were within +/- 1.0 dioptre of attempted correction.
TABLE 9.1 Laser refractive surgery procedures: comparison of the FDA's 2003 study with SNEC's efficacy and safety rates in 2014. |
|||
Post-operative 3-month comparison |
FDA (Allegretto laser) (U.S. Food and Drug Administration, 2003) N = 290 ≤ -7D |
SNEC (EX500 laser) (2014) N = 357 ≤ -7D |
|
Efficacy (%) |
Eyes with UAVA 6/12 or better |
96.4 |
99.7 |
Eyes with UAVA 6/6 or better |
68.9 |
83.8 |
|
Predictability (%) |
Eyes with predictability +/- 1.00D |
- |
98.8 |
Eyes with predictability +/- 0.50D |
- |
90.9 |
|
Safety (%) |
Eyes with loss of ≥ 2 lines BCVA |
1.8 |
0 |
Cases with improved or unchanged BCVA |
- |
94.4 |
BCVA, best-corrected visual acuity; D, dioptre; FDA, Food and Drug Administration; UAVA, unaided visual acuity.
Liu, Y. C., Pujara, T., & Mehta, J. S. (2014). New instruments for lenticule extraction in small incision lenticule extraction (SMILE). PLoS One, e113774.
Mohamed- Noriega, K., Riau, A. K., Lwin, N. C., Chaurasia, S. S., Tan, D. T., & Mehta, J. S. (2014). Early corneal nerve damage and recovery following small incision lenticule extraction (SMILE) and laser in situ keratomileusis (LASIK) Investigative Ophthalmology & Visual Science, 55, 1823-1834.
U.S. Food and Drug Administration. (2003). Summary of safety and effectiveness data for a supplemental premarket approval application. Retrieved from here.
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