Cirugía refractiva con láser excimer de frente de onda en adultos con errores de refracción
Information
- DOI:
- https://doi.org/10.1002/14651858.CD012687.pub2Copy DOI
- Database:
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- Cochrane Database of Systematic Reviews
- Version published:
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- 18 December 2020see what's new
- Type:
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- Intervention
- Stage:
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- Review
- Cochrane Editorial Group:
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Cochrane Eyes and Vision Group
- Copyright:
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- Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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Cited by:
Authors
Contributions of authors
Li SM and Abariga SA conceived and designed the study. Li SM and Abariga SA drafted the review; Kang MT and Wang NL provided critical and substantial comments regarding intellectual content. All authors approved the final version of the review.
Sources of support
Internal sources
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Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
External sources
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The capital health development scientific research project (2020‐2‐1081; 2016‐4‐2056), China
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Beijing Talents Found (2016000021223ZK28), China
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The National Natural Science Foundation of China (82071000), China
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Beijing Science Foundation for Distinguished Yong Scholars (JQ20029), China
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National Institute for Health Research (NIHR), UK
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Richard Wormald, Co‐ordinating Editor for Cochrane Eyes and Vision (CEV) acknowledged financial support for his CEV research sessions from the Department of Health through the award made by the NIHR to Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology for a Specialist Biomedical Research Centre for Ophthalmology.
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This review was supported by the NIHR, via Cochrane Infrastructure funding to the CEV UK editorial base.
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.
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Declarations of interest
Financial interests:
Li SM: none known.
Kang MT: none known.
Wang NL: none known.
Abariga SA: none known.
Intellectual and other interests: none
Acknowledgements
We gratefully acknowledge the following: Cochrane Eyes and Vision (CEV) and the editorial team for their support, guidance, and comments; Iris Gordon, Information Specialist for CEV for creating and executing the electronic search strategies; Professor Barbara Hawkins for the insightful comments and great support provided during the review process; and Sandra Finestone, consumer reviewer for evaluating the relevance of this review. We sincerely thank the following peer reviewers for their comments: Dr. Mujtaba Qazi (Pepose Vision Institute, Chesterfield MO) and Dr. Majid Moshirfar (John A. Moran Eye Center, Salt Lake City Utah).
This review was managed by CEV@US and was signed off for publication by Tianjing Li and Richard Wormald.
Version history
| Published | Title | Stage | Authors | Version |
| 2020 Dec 18 | Wavefront excimer laser refractive surgery for adults with refractive errors | Review | Shi-Ming Li, Meng-Tian Kang, Ning-Li Wang, Samuel A Abariga | |
| 2017 Jun 17 | Wavefront excimer laser refractive surgery for adults with refractive errors | Protocol | Shi‐Ming Li, Meng‐Tian Kang, Yuehua Zhou, Ning‐Li Wang, Kristina Lindsley | |
Differences between protocol and review
We decided post hoc to further stratify comparisons by subgroups (LASIK and PRK). We also decided to present additional tables for summary of findings for outcomes at six months. We also analyzed data for the outcome: proportion of participants with loss of one or more best‐spectacle correction visual acuity (BSCVA) as non‐events rather than events. Results were therefore reported as 'proportion of participants without loss of one or more BSCVA'. Samuel A. Abariga was added to the author team and Yuehua Zhou and Kristina Lindsley (both were co‐authors to the protocol) were excluded from the author team of the main review.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Astigmatism [surgery];
- Corneal Wavefront Aberration [*surgery];
- Hyperopia [surgery];
- Keratectomy, Subepithelial, Laser-Assisted [adverse effects, *methods];
- Keratomileusis, Laser In Situ [adverse effects, *methods];
- Lasers, Excimer [*therapeutic use];
- Myopia [surgery];
- Photorefractive Keratectomy [adverse effects, *methods];
- Randomized Controlled Trials as Topic;
- Treatment Outcome;
- Visual Acuity;
Medical Subject Headings Check Words
Adult; Female; Humans; Male; Middle Aged;
PICOs
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Forest plot of comparison: 1 Wavefront vs Conventional procedure, outcome: 1.1 Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment: 6 months.
Forest plot of comparison: 1 Wavefront vs Conventional procedure, outcome: 1.5 Proportion of eyes within ± 0.50 diopters (D) of target refraction: 6 months.
Forest plot of comparison: 1 Wavefront vs Conventional procedure, outcome: 1.7 Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months.
Comparison 1: Wavefront vs Conventional procedure, Outcome 1: Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment: 6 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 2: Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment:12 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 3: Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment: 6 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 4: Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment:12 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 5: Proportion of eyes within ± 0.50 diopters (D) of target refraction: 6 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 6: Proportion of eyes within ± 0.50 diopters (D) of target refraction: 12 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 7: Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 8: Mean refractive error expressed as mean spherical equivalent post‐treatment:12 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 9: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 1 month
Comparison 1: Wavefront vs Conventional procedure, Outcome 10: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 3 months
Comparison 1: Wavefront vs Conventional procedure, Outcome 11: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 6 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 1: Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment: 6 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 2: Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment:12 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 3: Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment: 6 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 4: Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment:12 months.
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 5: Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment: 6 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 6: Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment:12 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 7: Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months.
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 8: Mean refractive error expressed as mean spherical equivalent post‐treatment:12 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 9: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 1 month
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 10: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 3 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 11: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 6 months
Comparison 2: Wavefront‐optimized vs Wavefront‐guided, Outcome 12: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 12 months
Comparison 3: Wavefront‐guided LASIK vs Wavefront‐guided PRK, Outcome 1: Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment.
Comparison 3: Wavefront‐guided LASIK vs Wavefront‐guided PRK, Outcome 2: Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment.
Comparison 3: Wavefront‐guided LASIK vs Wavefront‐guided PRK, Outcome 3: Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment.
Comparison 3: Wavefront‐guided LASIK vs Wavefront‐guided PRK, Outcome 4: Mean refractive error expressed as mean spherical equivalent post‐treatment.
Comparison 3: Wavefront‐guided LASIK vs Wavefront‐guided PRK, Outcome 5: Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor
| Wavefront procedures compared to conventional procedures for adults with refractive errors | ||||||
| Participant or population: Adults with refractive errors | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with conventional procedure | Risk with wavefront | |||||
| Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment:12 months ‐ Procedure: PRK | 86 per 100 | 88 per 100 | RR 1.03 | 70 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment:12 months ‐ Procedure: LASIK | see comment | ‐ | ‐ | ‐ | ‐ | There are no data on LASIK for this outcome at 12 months |
| Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment:12 months ‐ Procedure PRK | 6 per 100 | 5 per 100 | RR 0.94 | 70 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction: 12 months ‐ Procedure PRK | 86 per 100 | 88 per 100 | RR 1.03 | 70 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction: 12 months ‐ Procedure LASIK | see comment | ‐ | ‐ | ‐ | ‐ | There are no data on LASIK for this outcome at 12 months |
| Mean refractive error expressed as mean spherical equivalent post‐treatment:12 months ‐ Procedure PRK | The mean refractive error expressed as mean spherical equivalent post‐treatment:12 months ‐ Procedure PRK was ‐0.114 | MD 0.04 higher | ‐ | 70 | ⊕⊝⊝⊝ | ‐ |
| Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment‐procedure LASIK; Mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor; proportion of eyes with significant visual loss (loss of 2 or more lines from pretreatment BSCVA); proportion of eyes with optical side effects, such as glare and halo:12 months | see comment | ‐ | ‐ | ‐ | ‐ | There was no data on these outcomes at 12 months |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded forImprecision. | ||||||
| Wavefront‐optimized procedures compared to wavefront‐guided procedures for adults with refractive errors | ||||||
| Participant or population: Adults with refractive errors | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with Any wavefront‐guided procedure | Risk with Any wavefront‐optimized | |||||
| Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment:12 months ‐ overall estimate | 97 per 100 | 97 per 100 | RR 1.00 | 618 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) post‐treatment:12 months ‐ overall estimate | 5 per 100 | 5 per 100 | RR 0.99 | 622 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment:12 months ‐ overall estimate | 91 per 100 | 93 per 100 | RR 1.02 | 480 | ⊕⊕⊝⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment:12 months ‐ Procedure PRK | The mean refractive error expressed as mean spherical equivalent post‐treatment:12 months ‐ Procedure PRK was −0.21 spherical equivalent | MD 0.07 spherical equivalent higher | ‐ | 334 | ⊕⊕⊝⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment:12 months ‐ Procedure LASIK | The mean refractive error expressed as mean spherical equivalent post‐treatment:12 months ‐ Procedure LASIK ranged from 0.26 spherical equivalent | MD 0.14 spherical equivalent lower | ‐ | 472 | ⊕⊕⊝⊝ | ‐ |
| Mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor: 12 months ‐ overall estimate | The mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor: 12 months was 0.26 | MD 0.03 higher | ‐ | 622 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes with significant visual loss (loss of 2 or more lines from pretreatment BSCVA): 12 months | see comment | ‐ | ‐ | ‐ | ‐ | One study that compared wavefront‐optimized LASIK versus wavefront‐guided LASIK reported on loss of 2 or more lines from pretreatment BSCVA that had not returned to baseline by 12 to 24 months after treatment (Manche 2013). Proportion of eyes with optical side effects, such as glare and halo |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded for risk of bias. bDowngraded for imprecision. cDowngraded for inconsistency. | ||||||
| Wavefront‐guided LASIK compared to wavefront‐guided PRK for adults with refractive errors | ||||||
| Participant or population: Adults with refractive errors | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with wavefront‐guided PRK | Risk with wavefront‐guided LASIK | |||||
| Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment. ‐ 12 months | 94 per 100 | 97 per 100 | RR 1.03 | 66 | ⊕⊝⊝⊝ | ‐ |
| Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment. ‐ 12 months | 6 per 100 | 6 per 100 | RR 1.03 | 66 | ⊕⊝⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment. ‐ 12 months | 909 per 1,000 | 882 per 1,000 | RR 0.97 | 66 | ⊕⊝⊝⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment. ‐ 12 months | The mean refractive error expressed as mean spherical equivalent post‐treatment. ‐ 12 months was −0.17 | MD 0.01 higher | ‐ | 66 | ⊕⊝⊝⊝ | ‐ |
| Mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor ‐ 12 months | The mean HOAs post‐treatment, measured by machine with wavefront sensor ‐ 12 months was 0.38 | MD 0.01 lower | ‐ | 66 | ⊕⊝⊝⊝ | ‐ |
| Proportion of eyes with significant visual loss (loss of 2 or more lines from pretreatment BSCVA): 12 months | see comment | ‐ | ‐ | ‐ | ‐ | This outcome was not reported |
| Proportion of eyes with optical side effects, such as glare and halo: 12 months | see comment | ‐ | ‐ | ‐ | ‐ | This outcome was not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded for risk of bias. | ||||||
| Wavefront compared to conventional procedure for adults with refractive errors | ||||||
| Participant or population: Adults with refractive errors | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with Conventional procedure | Risk with Wavefront | |||||
| Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment: 6 months ‐ overall estimate | 831 per 1000 | 831 per 1000 | RR 1.00 | 470 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) post‐treatment: 6 months ‐ overall estimate | 200 per 1000 | 216 per 1000 | RR 1.04 | 151 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction: 6 months ‐ Procedure PRK | 917 per 1000 | 816 per 1000 | RR 0.89 | 192 | ⊕⊝⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction: 6 months ‐ Procedure LASIK | 900 per 1000 | 999 per 1000 | RR 1.11 | 20 | ⊕⊝⊝⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months ‐ Procedure PRK | The mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months ‐ Procedure PRK was 0 | MD 0.06 higher | ‐ | 196 | ⊕⊝⊝⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months ‐ Procedure LASIK | The mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months ‐ Procedure LASIK was 0 | MD 0.11 higher | ‐ | 428 | ⊕⊝⊝⊝ | ‐ |
| Mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor: PRK procedure: 6 months | see comment | see comment | ‐ | 116 | ⊕⊝⊝⊝ | Two studies reported data on PRK. Due to substantial heterogeneity, we did not combine data in a meta‐analysis. Point estimates from Mastropasqua 2006 (MD = −0.21, 95% CI −0.26 to −0.16) suggest benefit in favor of wavefront‐guided PRK relative to conventional PRK (56 eyes of 56 participants). Estimates from Karimian 2010 (MD 0.17, 95% CI 0.02 to 0.32) favors conventional PRK (56 eyes, 28 participants). There were no data on LASIK for this outcome at 6 months |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded for risk of bias. | ||||||
| Wavefront‐optimized compared to wavefront‐guided for adults with refractive errors | ||||||
| Participant or population: Adults with refractive errors | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with Wavefront‐guided | Risk with Wavefront‐optimized | |||||
| Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment: 6 months | 982 per 1000 | 982 per 1000 | RR 1.00 | 444 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) post‐treatment: 6 months | 54 per 1000 | 54 per 1000 | RR 0.99 | 258 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment: 6 months | 938 per 1000 | 872 per 1000 | RR 0.93 | 258 | ⊕⊕⊝⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months. ‐ Procedure PRK | The mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months. ‐ Procedure PRK was 0 | MD 0.09 higher | ‐ | 138 | ⊕⊕⊕⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months. ‐ Procedure LASIK | The mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months. ‐ Procedure LASIK was 0 | MD 0.12 lower | ‐ | 280 | ⊕⊕⊕⊝ | ‐ |
| Mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor: 6 months | The mean HOAs post‐treatment, measured by machine with wavefront sensor: 6 months was 0 | MD 0.03 higher | ‐ | 478 | ⊕⊕⊝⊝ | ‐ |
| Proportion of eyes with significant visual loss (loss of 2 or more lines from pretreatment BSCVA) and proportion of eyes with optical side effects, such as glare and halo: 6 months | see comment | ‐ | ‐ | ‐ | ‐ | These two outcomes were not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded for risk of bias. | ||||||
| Wavefront‐guided LASIK compared to wavefront‐guided PRK for adults with refractive errors | ||||||
| Participant or population: Adults with refractive errors | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Certainty of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with Wavefront‐guided PRK | Risk with Wavefront‐guided LASIK | |||||
| Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment. ‐ 6 months | 939 per 1000 | 968 per 1000 | RR 1.03 | 66 | ⊕⊝⊝⊝ | ‐ |
| Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment. ‐ 6 months | 970 per 1000 | 970 per 1000 | RR 1.00 | 66 | ⊕⊝⊝⊝ | ‐ |
| Mean refractive error expressed as mean spherical equivalent post‐treatment. ‐ 6 months | The mean refractive error expressed as mean spherical equivalent post‐treatment. ‐ 6 months was 0 | MD 0 | ‐ | 66 | ⊕⊝⊝⊝ | ‐ |
| Mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor ‐ 6 months | The mean higher‐order aberrations (HOAs) post‐treatment, measured by machine with wavefront sensor ‐ 6 months was 0 | MD 0.02 higher | ‐ | 66 | ⊕⊝⊝⊝ | ‐ |
| Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment. ‐ 6 months | see comment | ‐ | ‐ | ‐ | ‐ | This outcome was not reported |
| Proportion of eyes with significant visual loss (loss of 2 or more lines from pretreatment BSCVA): 6 months | see comment | ‐ | ‐ | ‐ | ‐ | This outcome was not reported |
| Proportion of eyes with optical side effects, such as glare and halo: 6 months | see comment | ‐ | ‐ | ‐ | ‐ | This outcome was not reported |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| aDowngraded for risk of bias. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment: 6 months Show forest plot | 6 | 470 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.96, 1.03] |
| 1.1.1 Procedure PRK | 2 | 136 | Risk Ratio (IV, Random, 95% CI) | 0.95 [0.81, 1.12] |
| 1.1.2 Procedure LASIK | 4 | 334 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.96, 1.04] |
| 1.2 Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment:12 months Show forest plot | 1 | 70 | Risk Ratio (IV, Random, 95% CI) | 1.03 [0.86, 1.24] |
| 1.2.1 Procedure: PRK | 1 | 70 | Risk Ratio (IV, Random, 95% CI) | 1.03 [0.86, 1.24] |
| 1.3 Proportion of eyes that had lost 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment: 6 months Show forest plot | 3 | 151 | Risk Ratio (IV, Random, 95% CI) | 1.04 [0.93, 1.17] |
| 1.3.1 Procedure PRK | 1 | 80 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.93, 1.07] |
| 1.3.2 Procedure LASIK | 2 | 71 | Risk Ratio (IV, Random, 95% CI) | 1.11 [0.88, 1.40] |
| 1.4 Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment:12 months Show forest plot | 1 | 70 | Risk Ratio (IV, Random, 95% CI) | 0.94 [0.81, 1.09] |
| 1.4.1 Procedure PRK | 1 | 70 | Risk Ratio (IV, Random, 95% CI) | 0.94 [0.81, 1.09] |
| 1.5 Proportion of eyes within ± 0.50 diopters (D) of target refraction: 6 months Show forest plot | 4 | Risk Ratio (IV, Random, 95% CI) | Subtotals only | |
| 1.5.1 Procedure PRK | 3 | 192 | Risk Ratio (IV, Random, 95% CI) | 0.89 [0.78, 1.01] |
| 1.5.2 Procedure LASIK | 1 | 20 | Risk Ratio (IV, Random, 95% CI) | 1.11 [0.85, 1.44] |
| 1.6 Proportion of eyes within ± 0.50 diopters (D) of target refraction: 12 months Show forest plot | 1 | 70 | Risk Ratio (IV, Random, 95% CI) | 1.03 [0.86, 1.24] |
| 1.6.1 Procedure PRK | 1 | 70 | Risk Ratio (IV, Random, 95% CI) | 1.03 [0.86, 1.24] |
| 1.7 Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months Show forest plot | 8 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.7.1 Procedure PRK | 3 | 196 | Mean Difference (IV, Random, 95% CI) | 0.06 [‐0.09, 0.21] |
| 1.7.2 Procedure LASIK | 5 | 428 | Mean Difference (IV, Random, 95% CI) | 0.11 [‐0.05, 0.28] |
| 1.8 Mean refractive error expressed as mean spherical equivalent post‐treatment:12 months Show forest plot | 1 | 70 | Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 1.8.1 Procedure PRK | 1 | 70 | Mean Difference (IV, Random, 95% CI) | 0.04 [‐0.11, 0.18] |
| 1.9 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 1 month Show forest plot | 3 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.9.1 Procedure LASIK | 2 | 68 | Mean Difference (IV, Random, 95% CI) | ‐0.12 [‐0.22, ‐0.03] |
| 1.9.2 Procedure LASEK | 1 | 80 | Mean Difference (IV, Random, 95% CI) | ‐0.31 [‐0.38, ‐0.23] |
| 1.10 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 3 months Show forest plot | 5 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 1.10.1 Procedure PRK: 3 month | 1 | 132 | Mean Difference (IV, Random, 95% CI) | ‐0.04 [‐0.10, 0.02] |
| 1.10.2 Procedure LASIK: 3 month | 3 | 92 | Mean Difference (IV, Random, 95% CI) | ‐0.02 [‐0.04, 0.00] |
| 1.10.3 Procedure LASEK | 1 | 80 | Mean Difference (IV, Random, 95% CI) | ‐0.23 [‐0.26, ‐0.19] |
| 1.11 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 6 months Show forest plot | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| 1.11.1 Procedure PRK: 6 month | 2 | Mean Difference (IV, Random, 95% CI) | Totals not selected | |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 2.1 Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment: 6 months Show forest plot | 5 | 444 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.98, 1.02] |
| 2.1.1 Procedure PRK | 1 | 104 | Risk Ratio (IV, Random, 95% CI) | 0.94 [0.87, 1.02] |
| 2.1.2 Procedure LASIK | 4 | 340 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.98, 1.02] |
| 2.2 Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment:12 months Show forest plot | 5 | 618 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.99, 1.02] |
| 2.2.1 Procedure PRK | 2 | 334 | Risk Ratio (IV, Random, 95% CI) | 1.02 [0.98, 1.06] |
| 2.2.2 Procedure LASIK | 3 | 284 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.98, 1.02] |
| 2.3 Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment: 6 months Show forest plot | 4 | 258 | Risk Ratio (IV, Random, 95% CI) | 0.99 [0.94, 1.04] |
| 2.3.1 Procedure PRK | 1 | 104 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.95, 1.06] |
| 2.3.2 Procedure LASIK | 3 | 154 | Risk Ratio (IV, Random, 95% CI) | 0.96 [0.85, 1.08] |
| 2.4 Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment:12 months. Show forest plot | 5 | 622 | Risk Ratio (IV, Random, 95% CI) | 0.99 [0.96, 1.02] |
| 2.4.1 Procedure PRK | 2 | 334 | Risk Ratio (IV, Random, 95% CI) | 1.01 [0.97, 1.05] |
| 2.4.2 Procedure LASIK | 3 | 288 | Risk Ratio (IV, Random, 95% CI) | 0.97 [0.94, 1.01] |
| 2.5 Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment: 6 months Show forest plot | 4 | 258 | Risk Ratio (IV, Random, 95% CI) | 0.93 [0.87, 1.00] |
| 2.5.1 Procedure PRK | 1 | 104 | Risk Ratio (IV, Random, 95% CI) | 0.94 [0.86, 1.03] |
| 2.5.2 Procedure LASIK | 3 | 154 | Risk Ratio (IV, Random, 95% CI) | 0.92 [0.81, 1.04] |
| 2.6 Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment:12 months Show forest plot | 4 | 480 | Risk Ratio (IV, Random, 95% CI) | 1.02 [0.95, 1.09] |
| 2.6.1 Procedure PRK | 1 | 192 | Risk Ratio (IV, Random, 95% CI) | 1.06 [0.97, 1.15] |
| 2.6.2 Procedure LASIK | 3 | 288 | Risk Ratio (IV, Random, 95% CI) | 0.97 [0.86, 1.11] |
| 2.7 Mean refractive error expressed as mean spherical equivalent post‐treatment: 6 months. Show forest plot | 4 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.7.1 Procedure PRK | 1 | 138 | Mean Difference (IV, Random, 95% CI) | 0.09 [‐0.02, 0.20] |
| 2.7.2 Procedure LASIK | 3 | 280 | Mean Difference (IV, Random, 95% CI) | ‐0.12 [‐0.19, ‐0.05] |
| 2.8 Mean refractive error expressed as mean spherical equivalent post‐treatment:12 months Show forest plot | 6 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.8.1 Procedure PRK | 2 | 334 | Mean Difference (IV, Random, 95% CI) | 0.07 [‐0.03, 0.18] |
| 2.8.2 Procedure LASIK | 4 | 472 | Mean Difference (IV, Random, 95% CI) | ‐0.14 [‐0.19, ‐0.09] |
| 2.9 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 1 month Show forest plot | 4 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.9.1 Procedure PRK | 1 | 140 | Mean Difference (IV, Random, 95% CI) | 0.03 [‐0.03, 0.09] |
| 2.9.2 Procedure LASIK | 3 | 296 | Mean Difference (IV, Random, 95% CI) | 0.03 [‐0.01, 0.07] |
| 2.10 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 3 months Show forest plot | 6 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 2.10.1 Procedure PRK | 2 | 182 | Mean Difference (IV, Random, 95% CI) | 0.06 [0.01, 0.11] |
| 2.10.2 Procedure LASIK | 4 | 318 | Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.06, 0.04] |
| 2.11 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 6 months Show forest plot | 5 | 478 | Mean Difference (IV, Random, 95% CI) | 0.03 [0.00, 0.06] |
| 2.11.1 Procedure PRK | 1 | 138 | Mean Difference (IV, Random, 95% CI) | 0.06 [‐0.01, 0.13] |
| 2.11.2 Procedure LASIK | 4 | 340 | Mean Difference (IV, Random, 95% CI) | 0.03 [‐0.01, 0.06] |
| 2.12 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor: 12 months Show forest plot | 5 | 622 | Mean Difference (IV, Random, 95% CI) | 0.03 [‐0.01, 0.07] |
| 2.12.1 Procedure PRK | 2 | 334 | Mean Difference (IV, Random, 95% CI) | 0.02 [‐0.08, 0.13] |
| 2.12.2 Procedure LASIK | 3 | 288 | Mean Difference (IV, Random, 95% CI) | 0.03 [‐0.01, 0.06] |
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 3.1 Proportion of eyes with uncorrected visual acuity (UCVA) of 20/20 or better post‐treatment. Show forest plot | 1 | Risk Ratio (IV, Random, 95% CI) | Subtotals only | |
| 3.1.1 6 months | 1 | 66 | Risk Ratio (IV, Random, 95% CI) | 1.03 [0.93, 1.15] |
| 3.1.2 12 months | 1 | 66 | Risk Ratio (IV, Random, 95% CI) | 1.03 [0.93, 1.15] |
| 3.2 Proportion of eyes without loss of 1 or more lines of best spectacle‐corrected visual acuity (BSCVA) posttreatment. Show forest plot | 1 | Risk Ratio (IV, Random, 95% CI) | Subtotals only | |
| 3.2.1 12 months | 1 | 66 | Risk Ratio (IV, Random, 95% CI) | 1.03 [0.93, 1.15] |
| 3.3 Proportion of eyes within ± 0.50 diopters (D) of target refraction post‐treatment. Show forest plot | 1 | Risk Ratio (IV, Random, 95% CI) | Subtotals only | |
| 3.3.1 6 months | 1 | 66 | Risk Ratio (IV, Random, 95% CI) | 1.00 [0.92, 1.09] |
| 3.3.2 12 months | 1 | 66 | Risk Ratio (IV, Random, 95% CI) | 0.97 [0.82, 1.14] |
| 3.4 Mean refractive error expressed as mean spherical equivalent post‐treatment. Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.4.1 6 months | 1 | 66 | Mean Difference (IV, Random, 95% CI) | 0.00 [‐0.13, 0.13] |
| 3.4.2 12 months | 1 | 66 | Mean Difference (IV, Random, 95% CI) | 0.01 [‐0.18, 0.20] |
| 3.5 Mean higher‐order aberrations (HOAs) microns post‐treatment, measured by machine with wavefront sensor Show forest plot | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | |
| 3.5.1 1 month | 1 | 66 | Mean Difference (IV, Random, 95% CI) | ‐0.06 [‐0.15, 0.03] |
| 3.5.2 3 months | 1 | 66 | Mean Difference (IV, Random, 95% CI) | 0.00 [‐0.07, 0.07] |
| 3.5.3 6 months | 1 | 66 | Mean Difference (IV, Random, 95% CI) | 0.02 [‐0.05, 0.09] |
| 3.5.4 12 months | 1 | 66 | Mean Difference (IV, Random, 95% CI) | ‐0.01 [‐0.09, 0.07] |
