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Related reviews and protocols

Cochrane Clinical Answers

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Study flow diagram.
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Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

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

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 1 Structural outcome ‐ partial or complete retinal detachment.
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Analysis 1.1

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 1 Structural outcome ‐ partial or complete retinal detachment.

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 2 Structural outcome ‐ complete retinal detachment (unit of analysis: eyes).
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Analysis 1.2

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 2 Structural outcome ‐ complete retinal detachment (unit of analysis: eyes).

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 3 Refractive error ‐ very high myopia ‐ at 30 months of age (unit of analysis: eyes).
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Analysis 1.3

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 3 Refractive error ‐ very high myopia ‐ at 30 months of age (unit of analysis: eyes).

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 4 Refractive error ‐ spherical equivalent refractions ‐ at 30 months of age (unit of analysis: eyes).
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Analysis 1.4

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 4 Refractive error ‐ spherical equivalent refractions ‐ at 30 months of age (unit of analysis: eyes).

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 5 Mortality before discharge from primary hospital.
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Analysis 1.5

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 5 Mortality before discharge from primary hospital.

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 6 Mortality at 30 months of age.
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Analysis 1.6

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 6 Mortality at 30 months of age.

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 7 Local adverse effects ‐ corneal opacity requiring corneal transplant (unit of analysis: eyes).
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Analysis 1.7

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 7 Local adverse effects ‐ corneal opacity requiring corneal transplant (unit of analysis: eyes).

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 8 Local adverse effects ‐ lens opacity requiring cataract removal (unit of analysis: eyes).
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Analysis 1.8

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 8 Local adverse effects ‐ lens opacity requiring cataract removal (unit of analysis: eyes).

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Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 9 Recurrence of ROP by 54 weeks PMA.
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Analysis 1.9

Comparison 1 Anti‐VEGF vs cryo/laser therapy, Outcome 9 Recurrence of ROP by 54 weeks PMA.

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Comparison 2 Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy, Outcome 1 Structural outcome ‐ retinal detachment (unit of analysis: eyes).
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Analysis 2.1

Comparison 2 Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy, Outcome 1 Structural outcome ‐ retinal detachment (unit of analysis: eyes).

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Comparison 2 Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy, Outcome 2 Local adverse effects ‐ perioperative retinal haemorrhages (unit of analysis: eyes).
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Analysis 2.2

Comparison 2 Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy, Outcome 2 Local adverse effects ‐ perioperative retinal haemorrhages (unit of analysis: eyes).

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Comparison 2 Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy, Outcome 3 Recurrence of ROP by 55 weeks PMA.
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Analysis 2.3

Comparison 2 Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy, Outcome 3 Recurrence of ROP by 55 weeks PMA.

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Summary of findings for the main comparison. Intravitreal anti‐VEGF therapy compared to conventional laser/cryotherapy in preterm infants with type 1 ROP

Intravitreal anti‐VEGF therapy compared to conventional laser/cryotherapy in preterm infants with type 1 ROP

Patient or population: preterm infants with type 1 ROP
Settings:
Intervention: intravitreal anti‐VEGF therapy
Comparison: conventional laser/cryotherapy

Outcomes*

Illustrative comparative risks# (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

conventional laser/cryotherapy

intravitreal anti‐VEGF therapy

Structural outcome ‐ retinal detachment

Study population

RR 1.04
(0.21 to 5.13)

143
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1,2,3

27 per 1000

28 per 1000
(6 to 141)

Refractive error ‐ very high myopia ‐ at 30 months of age (unit of analysis: eyes)

Study population

RR 0.06
(0.02 to 0.2)

211
(1 RCT)

⊕⊕⊝⊝
LOW 1,4

416 per 1000

25 per 1000
(8 to 83)

Mortality before discharge from primary hospital

Study population

RR 1.5
(0.26 to 8.75)

150
(1 RCT)

⊕⊕⊝⊝
LOW 2,3,5

27 per 1000

40 per 1000
(7 to 233)

Mortality at 30 months of age

Study population

RR 0.86
(0.3 to 2.45)

150
(1 RCT)

⊕⊕⊝⊝
LOW 2,3,5

93 per 1000

80 per 1000
(28 to 229)

Local adverse effects ‐ corneal opacity requiring corneal transplant (unit of analysis: eyes)

Study population

RR 0.34
(0.01 to 8.26)

286
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1,2,3,4

7 per 1000

2 per 1000
(0 to 57)

Local adverse effects ‐ lens opacity requiring cataract removal (unit of analysis: eyes)

Study population

RR 0.15
(0.01 to 2.79)

286
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1,2,3,4

21 per 1000

3 per 1000
(0 to 57)

Recurrence of ROP by 54 weeks PMA

Study population

RR 0.22
(0.08 to 0.62)

143
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

260 per 1000

57 per 1000
(21 to 161)

*Only the outcomes for which data are available are reported here;

#The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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).
CI: Confidence interval;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Outcome assessment not blinded

295% CI around the pooled estimate includes both 1) no effect and 2) appreciable benefit or appreciable harm

3Number of events too small

4Serious risk of bias in analysis (unit of analysis error)

5Outcome assessment not blinded but outcome is objective

Figures and Tables -
Summary of findings for the main comparison. Intravitreal anti‐VEGF therapy compared to conventional laser/cryotherapy in preterm infants with type 1 ROP
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Summary of findings 2. Anti‐VEGF combined with laser/cryotherapy compared to laser/cryotherapy in preterm infants with type 1 ROP

Anti‐VEGF combined with laser/cryotherapy compared to laser/cryotherapy in preterm infants with type 1 ROP

Patient or population: preterm infants with type 1 ROP
Settings:
Intervention: anti‐VEGF combined with laser/cryotherapy
Comparison: laser/cryotherapy

Outcomes*

Illustrative comparative risks# (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

laser/cryotherapy

anti‐VEGF combined with laser/cryotherapy

Structural outcome ‐ retinal detachment (unit of analysis: eyes)

Study population

RR 0.26
(0.12 to 0.55)

152
(1 RCT)

⊕⊕⊝⊝
LOW 1,2,3

393 per 1000

102 per 1000
(47 to 216)

Local adverse effects ‐ perioperative retinal haemorrhages (unit of analysis: eyes)

Study population

RR 0.62
(0.24 to 1.56)

152
(1 RCT)

⊕⊝⊝⊝
VERY LOW 1,2,3,4

143 per 1000

89 per 1000
(34 to 223)

Recurrence of ROP by 55 weeks' PMA

Study population

RR 0.29
(0.12 to 0.7)

76
(1 RCT)

⊕⊕⊝⊝
LOW 1,3

500 per 1000

145 per 1000
(60 to 350)

*Only the outcomes for which data are available are reported here;

#The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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).
CI: Confidence interval;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Outcome assessment not blinded

2Serious risk of bias in analysis (unit of analysis error)

3Unclear risk of selection bias

495% CI around the pooled estimate includes both 1) no effect and 2) appreciable benefit or appreciable harm

Figures and Tables -
Summary of findings 2. Anti‐VEGF combined with laser/cryotherapy compared to laser/cryotherapy in preterm infants with type 1 ROP
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Comparison 1. Anti‐VEGF vs cryo/laser therapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Structural outcome ‐ partial or complete retinal detachment Show forest plot

1

143

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.21, 5.13]

1.1 Zone I

1

64

Risk Ratio (M‐H, Fixed, 95% CI)

0.21 [0.01, 4.26]

1.2 Zone II posterior

1

79

Risk Ratio (M‐H, Fixed, 95% CI)

5.13 [0.25, 103.45]

2 Structural outcome ‐ complete retinal detachment (unit of analysis: eyes) Show forest plot

1

26

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.01, 7.50]

3 Refractive error ‐ very high myopia ‐ at 30 months of age (unit of analysis: eyes) Show forest plot

1

211

Risk Ratio (M‐H, Fixed, 95% CI)

0.06 [0.02, 0.20]

3.1 Zone I

1

87

Risk Ratio (M‐H, Fixed, 95% CI)

0.07 [0.02, 0.30]

3.2 Zone II posterior

1

124

Risk Ratio (M‐H, Fixed, 95% CI)

0.05 [0.01, 0.34]

4 Refractive error ‐ spherical equivalent refractions ‐ at 30 months of age (unit of analysis: eyes) Show forest plot

1

211

Mean Difference (IV, Fixed, 95% CI)

5.68 [4.33, 7.02]

4.1 Zone I

1

87

Mean Difference (IV, Fixed, 95% CI)

6.93 [4.26, 9.60]

4.2 Zone II posterior

1

124

Mean Difference (IV, Fixed, 95% CI)

5.25 [3.69, 6.81]

5 Mortality before discharge from primary hospital Show forest plot

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

1.50 [0.26, 8.75]

5.1 Zone I

1

67

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.07, 15.80]

5.2 Zone II posterior

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.95 [0.18, 20.71]

6 Mortality at 30 months of age Show forest plot

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.30, 2.45]

6.1 Zone I

1

67

Risk Ratio (M‐H, Fixed, 95% CI)

0.62 [0.16, 2.38]

6.2 Zone II posterior

1

83

Risk Ratio (M‐H, Fixed, 95% CI)

1.46 [0.26, 8.31]

7 Local adverse effects ‐ corneal opacity requiring corneal transplant (unit of analysis: eyes) Show forest plot

1

286

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.01, 8.26]

7.1 Zone I

1

128

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 Zone II posterior

1

158

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.01, 8.26]

8 Local adverse effects ‐ lens opacity requiring cataract removal (unit of analysis: eyes) Show forest plot

1

286

Risk Ratio (M‐H, Fixed, 95% CI)

0.15 [0.01, 2.79]

8.1 Zone I

1

128

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 Zone II posterior

1

158

Risk Ratio (M‐H, Fixed, 95% CI)

0.15 [0.01, 2.79]

9 Recurrence of ROP by 54 weeks PMA Show forest plot

1

143

Risk Ratio (M‐H, Fixed, 95% CI)

0.22 [0.08, 0.62]

9.1 Zone I

1

64

Risk Ratio (M‐H, Fixed, 95% CI)

0.15 [0.04, 0.62]

9.2 Zone II posterior

1

79

Risk Ratio (M‐H, Fixed, 95% CI)

0.41 [0.08, 1.99]
Figures and Tables -
Comparison 1. Anti‐VEGF vs cryo/laser therapy
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Comparison 2. Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Structural outcome ‐ retinal detachment (unit of analysis: eyes) Show forest plot

1

152

Risk Ratio (M‐H, Fixed, 95% CI)

0.26 [0.12, 0.55]

2 Local adverse effects ‐ perioperative retinal haemorrhages (unit of analysis: eyes) Show forest plot

1

152

Risk Ratio (M‐H, Fixed, 95% CI)

0.62 [0.24, 1.56]

3 Recurrence of ROP by 55 weeks PMA Show forest plot

1

76

Risk Ratio (M‐H, Fixed, 95% CI)

0.29 [0.12, 0.70]
Figures and Tables -
Comparison 2. Anti‐VEGF plus cryo/laser therapy vs cryo/laser therapy
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