Evidence map›Paper›PMID 41016970›Full record

ArticleOphthalmology and therapy2025

Comparison of U.S. FDA Premarket Approval Studies Between Ray Tracing-Guided LASIK with InnovEyes Sightmap Versus Topography-Guided LASIK Using Custom Ablation Treatment (T-CAT).

Mina M Sitto, Majid Moshirfar, Triston B Crook, Phillip C Hoopes

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Article in Ophthalmology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Mina M SittoHoopes Vision Research Center, Hoopes Vision, 11820 S. State St. #200, Draper, UT, 84020, USA.
Majid MoshirfarHoopes Vision Research Center, Hoopes Vision, 11820 S. State St. #200, Draper, UT, 84020, USA. cornea2020@me.com.ORCID http://orcid.org/0000-0003-1024-6250
Triston B CrookNoorda College of Osteopathic Medicine, Provo, UT, USA.
Phillip C HoopesHoopes Vision Research Center, Hoopes Vision, 11820 S. State St. #200, Draper, UT, 84020, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo compare the U.S. Food and Drug Administration (FDA) premarket approval (PMA) trials of topography-guided laser in situ keratomileusis (TG-LASIK) and ray tracing-guided LASIK (RT-LASIK) for the treatment of myopia and myopic astigmatism.

methodsThis comparative study was conducted between TG-LASIK (P020050/S012; Alcon Laboratories, Inc., Fort Worth, TX, USA) with Allegretto Wave Eye-Q laser and topography-guided custom ablation treatment planning software, and "WaveLight Plus" RT-LASIK (P020050/S043; Alcon Laboratories, Inc.) using the WaveLight EX500 excimer laser and InnovEyes Sightmap. Clinical outcomes were compared, including visual and refractive measures, astigmatic correction, mesopic contrast sensitivity, higher-order aberrations, and patient-reported outcomes.

resultsThis analysis included 249 eyes (212 patients) that underwent TG-LASIK and 336 eyes (168 patients) that underwent RT-LASIK. At 12 months, uncorrected distance visual acuity of 20/16 or better (64.8% TG-LASIK vs. 70.2% RT-LASIK) and 20/20 or better (92.6% TG-LASIK vs. 94.4% RT-LASIK) did not differ statistically between platforms. However, more TG-LASIK eyes had 20/10 or better (15.7% vs. 2.5%, P < 0.001) and 20/12.5 or better (34.4% vs. 26.4%, P = 0.044) than RT-LASIK eyes. Both platforms demonstrated comparable refractive predictability and stability (P > 0.05). For preoperative cylinder between - 1.00 to - 4.00 D, RT-LASIK showed greater astigmatic overcorrection (P < 0.05). At 3 months, RT-LASIK showed higher mesopic contrast sensitivity at 3, 6, and 12 cycles per degree under glare, with more eyes achieving clinically significant gains compared to TG-LASIK (P < 0.001). Both platforms induced changes in total higher-order aberrations, although not clinically significant. RT-LASIK also reduced spherical aberration from baseline. Both procedures showed a reduction in symptom severity for glare, halos, starburst, double vision, and dry eye.

conclusionsWhile TG-LASIK showed superior visual acuity outcomes, RT-LASIK was associated with higher contrast sensitivity; however, both platforms demonstrate excellent visual and refractive outcomes. The majority of published studies are consistent with FDA PMA trends, showing potential reductions in spherical aberration and higher rates of 20/20 or better visual acuity with RT-LASIK.

Indexed as

AccommodationComaContouraHartmann–ShackHigh-order aberrationsRay-tracingVARIOWavefront-guidedWavefront-optimizedWaveLight Plus

Identifiers

PMID41016970
PMCPMC12579080

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.