Efficacy and Safety of Personalized Topography-Guided-Lasik Laser Refractive Correction: A Targeted Literature Review
Zhang J1, Gateri L1, Hsiao CW2, Kambli A3, Persaud E3
1Alcon Vision, Fort Worth, TX, USA, 2Alcon Inc., Fort Worth, TX, China, 3EVERSANA, Burlington, ON, Canada
OBJECTIVES: Topography-guided Laser Assisted In-situ Keratomileusis (TG-LASIK) provides patients with corrected visual acuity and quality within a short period after surgery. A targeted literature review assessed the efficacy and safety of personalized TG-LASIK and its use with clinical decision support software.
METHODS: Searches were performed in MEDLINE with terms including “myopia”, “astigmatism”, “LASIK”, “topography”, “analytics software”, and “topolyzer”. English-language observational studies and randomized control trials (RCTs) published between Jan-01-2015 and Sept-01-2022 were included. Visual, refractive, and safety outcomes were extracted for the 3-month post-operative time point. Statistical significance required P<0.05.
RESULTS: Five studies compared personalized TG-LASIK with non-personalized small incision lenticular extraction (SMILE) at 3 months (n=4 for 1 RCT, 3 observational). A significantly greater % of personalized LASIK patients had ≥20/16 uncorrected distance visual acuity (UDVA), gained 2+ corrected distance visual acuity (CDVA) Snellen lines, and mean cylindrical refraction within ±0.25D compared with non-personalized SMILE (n=1 for each). Personalized LASIK had numerically higher % patients ≥20/13 UDVA (n=2), gain of 1 CDVA line (n=1), significantly lower high order aberration (n=1) and numerically lower objective scatter (n=1) compared with SMILE. Three-month outcomes across 7 non-comparative personalized TG-LASIK studies found % patients achieving UDVA ≥20/16 and ≥20/12.5 to range from 9-89% (n=7) and 6-28% (n=6), respectively. Four studies compared the efficacy of personalized TG-LASIK using a clinical decision support software; this improved visual acuity significantly compared with personalized LASIK based on manifest (n=3 retrospective) or topographic (n=1 retrospective) cylinders.
CONCLUSIONS: Refractive error correction using personalized TG-LASIK offers patients substantial advantages in visual, refractive and safety outcomes compared with SMILE. Use of TG-LASIK with a clinical support software is expected to provide superior visual acuity outcomes compared with manifest or topographic measurements.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 6, S2 (June 2023)
Clinical Outcomes, Study Approaches
Comparative Effectiveness or Efficacy, Literature Review & Synthesis