Efficacy and Safety of Personalized Topography-Guided-Lasik Laser Refractive Correction: A Targeted Literature Review

Author(s)

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

2023-05, ISPOR 2023, Boston, MA, USA

Value in Health, Volume 26, Issue 6, S2 (June 2023)

Code

CO221

Topic

Clinical Outcomes, Study Approaches

Topic Subcategory

Comparative Effectiveness or Efficacy, Literature Review & Synthesis

Disease

Surgery

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