Scolaris Content Display Scolaris Content Display

Study flow diagram.

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Figure 1

Study flow diagram.

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

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Figure 2

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

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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Figure 3

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

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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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].

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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Figure 5

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

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

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Figure 6

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

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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Figure 7

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

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

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Analysis 1.1

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

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

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Analysis 1.2

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

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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Analysis 1.3

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

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

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Analysis 1.4

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

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

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Analysis 1.5

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

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

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Analysis 1.6

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

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

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Analysis 1.7

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

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)

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

Figuras y tablas -
Comparison 1. PBM treatment versus control for non‐exudative AMD