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Cochrane Database of Systematic Reviews

Fotobiomodulación para la degeneración macular senil no exudativa

Information

DOI:
https://doi.org/10.1002/14651858.CD013029.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 06 May 2021see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:

  1. Cochrane Eyes and Vision Group

Copyright:
  1. Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Christin Henein

    Correspondence to: Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK

    [email protected]

    NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK

  • David HW Steel

    Biosciences Institute, Newcastle University, Newcastle upon Tyne, UK

    Sunderland Eye Infirmary, Sunderland, UK

Contributions of authors

CH prepared the review draft and DS reviewed and edited the draft.
CH prepared the protocol draft and DS reviewed and edited the draft.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • National Institute for Health Research (NIHR), UK

    • 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 National Institute for Health Research to Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology for a Specialist Biomedical Research Centre for Ophthalmology.

    • 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.

Declarations of interest

CH: holds a National Institute for Health Research (NIHR) Academic Clinical Fellowship Award. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
DS: has acted as a consultant to a number of companies unrelated to the subject matter of this review.

Acknowledgements

Cochrane Eyes and Vision (CEV) created and executed the electronic search strategies. We thank Anupa Shah (Managing Editor for CEV) and the CEV UK editorial base for their assistance with this review and Tim Jackson and Noemi Lois for peer review.

Version history

Published

Title

Stage

Authors

Version

2021 May 06

Photobiomodulation for non‐exudative age‐related macular degeneration

Review

Christin Henein, David HW Steel

https://doi.org/10.1002/14651858.CD013029.pub2

2018 May 14

Photobiomodulation for non‐exudative age‐related macular degeneration

Protocol

Christin Henein, David HW Steel

https://doi.org/10.1002/14651858.CD013029

Differences between protocol and review

We could not conduct an intention‐to‐treat (ITT) analysis as ITT data was not available in the included trials. As there were fewer than 10 trials included in a meta‐analysis, assessment of publication bias was not possible (Chapter 8 of the Cochrane Handbook for Systematic Reviews of InterventionsHiggins 2011).

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Study flow diagram.

Figures and Tables -
Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for included study.

Figures and Tables -
Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for included study.

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Forest plot of comparison: 1 PBM treatment versus no treatment for non‐exudative AMD, outcome: 1.1 BCVA at 12 months [LogMar].

Figures and Tables -
Figure 3

Forest plot of comparison: 1 PBM treatment versus no treatment for non‐exudative AMD, outcome: 1.1 BCVA at 12 months [LogMar].

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Forest plot of comparison: 1 PBM treatment versus control for non‐exudative AMD, outcome: 1.3 Contrast sensitivity at 12 months Level E [18cycles/degree].

Figures and Tables -
Figure 4

Forest plot of comparison: 1 PBM treatment versus control for non‐exudative AMD, outcome: 1.3 Contrast sensitivity at 12 months Level E [18cycles/degree].

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Forest plot of comparison: 1 PBM treatment versus control for non‐exudative AMD, outcome: 1.4 Self‐reported visual function [VFQ‐48].

Figures and Tables -
Figure 5

Forest plot of comparison: 1 PBM treatment versus control for non‐exudative AMD, outcome: 1.4 Self‐reported visual function [VFQ‐48].

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Forest plot of comparison: 1 PBM treatment versus control for non‐exudative AMD, outcome: 1.6 Conversion to exudative AMD.

Figures and Tables -
Figure 6

Forest plot of comparison: 1 PBM treatment versus control for non‐exudative AMD, outcome: 1.6 Conversion to exudative AMD.

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Forest plot of comparison: 1 PBM treatment versus no treatment for non‐exudative AMD, outcome: 1.5 AMD progression at 12 months.

Figures and Tables -
Figure 7

Forest plot of comparison: 1 PBM treatment versus no treatment for non‐exudative AMD, outcome: 1.5 AMD progression at 12 months.

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Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 1: BCVA at 12 months [LogMar]

Figures and Tables -
Analysis 1.1

Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 1: BCVA at 12 months [LogMar]

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Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 2: BCVA at 3 months [LogMar]

Figures and Tables -
Analysis 1.2

Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 2: BCVA at 3 months [LogMar]

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Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 3: Contrast sensitivity at 12 months Level E [18cycles/degree]

Figures and Tables -
Analysis 1.3

Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 3: Contrast sensitivity at 12 months Level E [18cycles/degree]

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Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 4: Self‐reported visual function

Figures and Tables -
Analysis 1.4

Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 4: Self‐reported visual function

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Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 5: Health‐related quality of life EQ‐5D

Figures and Tables -
Analysis 1.5

Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 5: Health‐related quality of life EQ‐5D

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Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 6: Conversion to exudative AMD

Figures and Tables -
Analysis 1.6

Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 6: Conversion to exudative AMD

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Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 7: AMD progression at 12 months

Figures and Tables -
Analysis 1.7

Comparison 1: PBM treatment versus control for non‐exudative AMD, Outcome 7: AMD progression at 12 months

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Summary of findings 1. Photobiomodulation treatment compared to sham or no treatment for non‐exudative age‐related macular degeneration

PBM treatment compared to sham or no treatment for non‐exudative AMD

Patient or population: people with non‐exudative AMD (AREDS 2 to 4)
Setting: ophthalmology clinics
Intervention: PBM treatment
Comparison: no treatment or sham treatment

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of eyes
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with no treatment

Risk with PBM treatment

Best‐corrected visual acuity at 12 months [logMAR]

Measured on the logMAR scale, range ‐1.3 to 1.0. Lower scores represent better vision.

The mean best‐corrected visual acuity ranged across control groups from 0.24 to 0.96 logMAR

Mean logMAR score in the PBM group was on average 0.02 logMAR higher (worse)
(‐0.02 lower to 0.05 higher)

‐

90
(2 RCTs)

⊕⊕⊝⊝a,b
LOW

Contrast sensitivity at Level E [18 cycles/degree] at 12 months

Higher scores represent better contrast sensitivity.

On average there was no change In contrast sensitivity at Level E from baseline

Mean change In contrast sensitivity (Level E, 18 cycles/degree) was approximately 0.3 higher (better) with PBM (0.23 higher to 0.35 higher)

‐

30

(1 RCT)

⊕⊕⊝⊝a,b
LOW

Near vision

No studies reported this outcome

Low luminance deficit score

No studies reported this outcome

Reading speed

No studies reported this outcome

Self‐reported visual function at 12 months

Measured with VFQ‐48 questionnaire. Higher scores represent better reported visual function.

Average self‐reported

visual function score was 5.19

Mean visual function score was 0.43 higher (worse)in the PBM group (‐0.17 lower to 1.03 higher)

‐

47
(1 RCT)

⊕⊕⊝⊝a,b
LOW

Adverse events:

AMD progression at 12 months

Defined as increased drusen volume or onset of advanced AMD.

Conversion to exudative AMD at 12 months

Assessed by clinical examination and retinal

optical coherence tomography.

483 per 1,000 study population

381 per 1,000 (198 to 739)

RR 0.79 (0.41 to 1.53)

50 (1 RCT)

⊕⊕⊝⊝a,b LOW

43 per 1,000 study population

41 per 1,000 (7 to 231)

RR 0.97
(0.17 to 5.44)

96
(2 RCTs)

⊕⊝⊝⊝b,c
VERY LOW

*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).

AMD: age‐related macular degeneration; AREDS: age‐related eye disease study classification; CI: confidence interval; OR: odds ratio; PBM: photobiomodulation; RR: risk ratio

GRADE Working Group grades of evidence
High‐certainty: we are very confident that the true effect lies close to that of the estimate of the effect
Moderate‐certainty: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low‐certainty: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect.
Very low‐certainty: We have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.

Reason for downgrading certainty of evidence

a. ‐1 for imprecision as sample size was underpowered
b. ‐1 for performance and attrition bias
c. ‐2 for very wide confidence intervals including 1 (null effect)

Figures and Tables -
Summary of findings 1. Photobiomodulation treatment compared to sham or no treatment for non‐exudative age‐related macular degeneration
Navigate to table in Review
Comparison 1. PBM treatment versus control for non‐exudative AMD

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 BCVA at 12 months [LogMar] Show forest plot

2

90

Mean Difference (IV, Fixed, 95% CI)

0.02 [‐0.02, 0.05]

1.2 BCVA at 3 months [LogMar] Show forest plot

2

78

Mean Difference (IV, Fixed, 95% CI)

‐0.07 [‐0.13, ‐0.00]

1.3 Contrast sensitivity at 12 months Level E [18cycles/degree] Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.4 Self‐reported visual function Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.5 Health‐related quality of life EQ‐5D Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.6 Conversion to exudative AMD Show forest plot

2

96

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.17, 5.44]

1.7 AMD progression at 12 months Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figures and Tables -
Comparison 1. PBM treatment versus control for non‐exudative AMD
Navigate to table in Review