Summary of findings 2. Summary of findings: intravitreal bevacizumab plus intravitreal steroid versus macular laser for diabetic macular oedema.
| Intravitreal bevacizumab plus intravitreal steroid versus macular laser for diabetic macular oedema | ||||||
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Patient or population: adults with centre‐involving diabetic macular oedema Setting: eye care clinic Intervention: intravitreal bevacizumab plus intravitreal steroid (anti‐VEGF/steroid) Comparison: macular laser | ||||||
| Outcomes | Illustrative comparative risks* | Relative effect (95% CI) | No of eyes (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Macular laser | Anti‐VEGF/steroid | |||||
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Mean change in visual acuity at 1 year (number of letters read on logMAR chart) |
The mean visual acuity gain at 1 year was 1 letter with a standard deviation of 17 letters in the laser comparator group | The mean number of letters read was 4.00 more in the anti‐VEGF/steroid group (95% CI −2.70 to 10.70) | — | 80 (1) | Lowa | |
| Gain or loss of 10 or more letters visual acuity at 1 year | Not reported | |||||
| Mean change in central macular thickness at 1 year | The mean change in central macular thickness at 1 year was an increase of 6 μm with a standard deviation of 36 microns in the laser comparator group | The mean reduction in central macular thickness was on average 16 μm greater in the anti‐VEGF/steroid group (95% CI −68.93 to 36.93) | — | 80 (1) | Lowa | |
| Significant intraocular inflammation at follow‐up (from 6 months onwards) | Not reported | |||||
| Development of cataract at follow‐up (from 6 months onwards) | 20 per 1000 | 85 per 1000 (20 to 301 per 1000) |
Peto OR 4.58 (0.99 to 21.10) | 100 (1) | Very lowb | |
| Raised Intraocular Pressure at follow‐up (from 6 months onwards) | 1 per 1000 | 9 per 1000 (3 to 31 per 1000) |
Peto OR 9.49 (2.86 to 31.51) | 100 (1) | Very lowb | There was 1 participant who needed glaucoma drainage surgery in the anti‐VEGF/steroid group. Threshold for glaucoma drainage surgery not specified in the included study. |
| Systemic adverse events at follow‐up (from 6 months onwards) | Not reported | |||||
| Quality of life at follow‐up (from 6 months onwards) | Not reported | |||||
| *The assumed risk is the control group risk across studies. The corresponding risk is based on the assumed risk in the comparison group and the relative effect of the intervention. CI: confidence interval; RR: risk ratio; MD: mean difference; SD: standard deviation. | ||||||
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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 | ||||||
aDowngraded one level because of risk of bias and by one level due to imprecision.
bDowngraded one level because of risk of bias and by two levels due to imprecision (only 1 event in the comparator group).