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Cochrane Database of Systematic Reviews

Laser fotopembekuan bagi retinopati diabetes proliferatif

Información

DOI:
https://doi.org/10.1002/14651858.CD011234.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 24 noviembre 2014see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Salud ocular y de la visión

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Jennifer R Evans

    Correspondencia a: Cochrane Eyes and Vision Group, ICEH, London School of Hygiene & Tropical Medicine, London, UK

    [email protected]

  • Manuele Michelessi

    Ophthalmology, Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmolologia‐IRCCS, Rome, Italy

  • Gianni Virgili

    Department of Translational Surgery and Medicine, Eye Clinic, University of Florence, Florence, Italy

Contributions of authors

JE prepared a first draft of the protocol, which was revised by GV.

JE and MM screened search results and extracted data. GV and MM reviewed and commented on various drafts of the review.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Italian Ministry of Health and Fondazione Roma, Italy.

    The contribution of the IRCCS Fondazione Bietti in this paper was supported by the Italian Ministry of Health and by Fondazione Roma, Italy

  • National Institute for Health Research (NIHR), UK.

    • Richard Wormald, Co‐ordinating Editor for the Cochrane Eyes and Vision Group (CEVG) acknowledges financial support for his CEVG 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.

    • The NIHR also funds the CEVG Editorial Base in London.

    • The Cochrane Review Incentive Scheme provided funding for Jennifer Evans to assist with completion of this review.

    The views expressed in this publication are those of the authors and not necessarily those of the NIHR, NHS, or the Department of Health.

Declarations of interest

JE: none known
MM: none known
GV: none known

Acknowledgements

The Cochrane Eyes and Vision Group (CEVG) created and executed the electronic search strategies. We thank Catey Bunce, Christian Fau, Noemi Lois and Richard Wormald for their comments on the protocol and David Yorston, Andrew Elders and Christian Fau for their comments on the review. We thank Anupa Shah, the Managing Editor, for her assistance throughout the review process.

Version history

Published

Title

Stage

Authors

Version

2014 Nov 24

Laser photocoagulation for proliferative diabetic retinopathy

Review

Jennifer R Evans, Manuele Michelessi, Gianni Virgili

https://doi.org/10.1002/14651858.CD011234.pub2

2014 Aug 05

Laser photocoagulation for diabetic retinopathy

Protocol

Jennifer R Evans, Christian Fau, Gianni Virgili

https://doi.org/10.1002/14651858.CD011234

Differences between protocol and review

Title

On the recommendation of a clinical peer reviewer we changed the title of this review from "laser photocoagulation for diabetic retinopathy" to "laser photocoagulation for proliferative diabetic retinopathy". The reviewer felt that clinicians seeing the broader title would expect to see diabetic macular oedema (DMO) included in this review but this is specifically excluded as there is a separate review looking at laser for DMO (Jorge 2013).

Outcomes

We changed 'distance corrected near visual acuity' to 'near visual acuity'. We did not find any data on near visual acuity, either distance corrected or not.

We moved the outcome 'severe visual loss' out of adverse effects and further up the list, refecting the use of this outcome generally as a measure of effect rather than an adverse effect as originally defined in our protocol. We considered this outcome at one year follow‐up as for the other effectiveness outcomes (and not, as originally planned, within three months of treatment).

We removed the outcome 'secondary choroidal neovascularisation' for future updates. This outcome is more of a concern after treatment for diabetic macular oedema. We did not find any data on this outcome.

Measures of effect

We planned to calculate the risk ratio for dichotomous variables where the event risk was greater than 10%, the odds ratio for dichotomous variables where the event risk was less than 10% and for very rare events (less than 1%) the Peto odds ratio. In fact for most analyses the event risk in the control group was greater than, or approximately, 10% and we felt that it would be confusing to report an odds ratio for only one outcome (severe visual loss) where the event rate was 4%. We have therefore only used the risk ratio as the measure of effect for dichotomous variables. This decision has not affected the conclusions drawn. For the outcome of severe visual loss the reported risk ratio was 0.46 (95% CI 0.24 to 0.86) and this is similar to the odds ratio of 0.40 (95% CI 0.18 to 0.88).

Data synthesis

We planned that, in cases of substantial heterogeneity, for example differences in direction of effect, or where the I2 statistic was greater than 50% and the Chi2 statistic less than 0.1, such that the pooled result did not summarize the individual trial results adequately, we would not provide a pooled estimate, unless visual inspection of the forest plot indicated it might be appropriate to do so (for example, if all effect estimates were in the same direction). For one analysis, Analysis 1.1, the effect estimates were reasonably close to 1 and we report a pooled estimate even though the effect estimates were not in the same direction.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Results from searching for studies for inclusion in the review
Figuras y tablas -
Figure 1

Results from searching for studies for inclusion in the review

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

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

Forest plot of comparison: 1 Laser photocoagulation versus control, outcome: 1.1 Loss of 15 or more letters BCVA at 12 months
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Laser photocoagulation versus control, outcome: 1.1 Loss of 15 or more letters BCVA at 12 months

Forest plot of comparison: 1 Laser photocoagulation versus control, outcome: 1.4 Severe visual loss (BCVA < 6/60)
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Laser photocoagulation versus control, outcome: 1.4 Severe visual loss (BCVA < 6/60)

Forest plot of comparison: 1 Laser photocoagulation versus control, outcome: 1.5 Progression of diabetic retinopathy
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Laser photocoagulation versus control, outcome: 1.5 Progression of diabetic retinopathy

Comparison 1 Laser photocoagulation versus control, Outcome 1 Loss of 15 or more letters BCVA at 12 months.
Figuras y tablas -
Analysis 1.1

Comparison 1 Laser photocoagulation versus control, Outcome 1 Loss of 15 or more letters BCVA at 12 months.

Comparison 1 Laser photocoagulation versus control, Outcome 2 Loss of 15 or more letters BCVA at 2 years.
Figuras y tablas -
Analysis 1.2

Comparison 1 Laser photocoagulation versus control, Outcome 2 Loss of 15 or more letters BCVA at 2 years.

Comparison 1 Laser photocoagulation versus control, Outcome 3 Loss of 15 or more letters BCVA at 3 years.
Figuras y tablas -
Analysis 1.3

Comparison 1 Laser photocoagulation versus control, Outcome 3 Loss of 15 or more letters BCVA at 3 years.

Comparison 1 Laser photocoagulation versus control, Outcome 4 Severe visual loss (BCVA < 6/60).
Figuras y tablas -
Analysis 1.4

Comparison 1 Laser photocoagulation versus control, Outcome 4 Severe visual loss (BCVA < 6/60).

Comparison 1 Laser photocoagulation versus control, Outcome 5 Progression of diabetic retinopathy.
Figuras y tablas -
Analysis 1.5

Comparison 1 Laser photocoagulation versus control, Outcome 5 Progression of diabetic retinopathy.

Comparison 1 Laser photocoagulation versus control, Outcome 6 Vitreous haemorrhage.
Figuras y tablas -
Analysis 1.6

Comparison 1 Laser photocoagulation versus control, Outcome 6 Vitreous haemorrhage.

Summary of findings for the main comparison. Laser photocoagulation compared to control for diabetic retinopathy

Laser photocoagulation compared to no treatment (or deferred treatment) for diabetic retinopathy

Patient or population: people with diabetic retinopathy
Settings: Ophthalmology clinics
Intervention: laser photocoagulation
Comparison: no treatment or deferred treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk*

Corresponding risk

No treatment or deferred treatment

Laser photocoagulation

Loss of 15 or more letters BCVA

Follow‐up: 12 months

Low risk (non‐proliferative DR)

RR 0.99
(0.89 to 1.11)

8926
(2 RCTs)

⊕⊕⊝⊝
LOW 1,2

The pooled RR 0.99 (0.89 to 1.11) is derived from one study with mainly low risk population RR 1.07 (0.92 to 1.23) and one study with mainly high risk population 0.86 (0.71 to 1.04)

100 per 1000

99 per 1000
(89 to 111)

High risk (proliferative DR)

250 per 1000

248 per 1000
(223 to 278)

BCVA measured using logMAR acuity (0 = 6/6 visual acuity, higher score is worse visual acuity)

Follow‐up: 12 months

The mean BCVA at 12 months in the control group was 0.12 logMAR

The mean BCVA at 12 months in the intervention group was 0.02 logMAR units higher (worse; 0.23 lower to 0.27 higher)

36
(1 RCT)

⊕⊕⊝⊝
LOW 1,3

Severe visual loss (BCVA < 6/60)

Follow‐up: 12 months

Low risk (non‐proliferative DR)

RR 0.46
(0.24 to 0.86)

9276
(4 RCTs)

⊕⊕⊕⊝
MODERATE 1,4

10 per 1000

5 per 1000
(2 to 9)

High risk (proliferative DR)

50 per 1000

23 per 1000
(12 to 43)

Progression of diabetic retinopathy

Follow‐up: 12 months

Low risk (non‐proliferative DR)

RR 0.49
(0.37 to 0.64)

8331
(4 RCTs)

⊕⊕⊝⊝
LOW 1,5

100 per 1000

49 per 1000
(37 to 64)

High risk (proliferative DR)

400 per 1000

196 per 1000

(148 to 256)

Quality of life

Follow‐up: 12 months

See comment

See comment

No studies reported this outcome

Pain

Follow‐up: at time of treatment

See comment

See comment

No studies reported this outcome

Loss of driving licence

Follow‐up: within three months of treatment

See comment

See comment

No studies reported this outcome

*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; DR: diabetic retinopathy; BCVA: Best corrected visual acuity

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.

*Estimates of assumed risk are indicative only, as estimates at 12 months were not available in all studies. For the low risk populations they were estimated from ETDRS (but acknowledging that the control group received deferred laser) and for the high risk populations they were estimated from DRS and Hercules 1977.

1Downgraded for risk of bias (‐1): studies were not masked and treatment groups different

2Downgraded for inconsistency (‐1): I2 = 69% and effect estimates were in different directions. See comments for details

3Downgraded for imprecision (‐1): wide confidence intervals

4 There was heterogeneity (I2 = 70%) but all effect estimates favoured laser photocoagulation so we did not downgrade for inconsistency

5Downgraded for indirectness (‐1): study results were reported at 1, 3, 4 and 5 years

Figuras y tablas -
Summary of findings for the main comparison. Laser photocoagulation compared to control for diabetic retinopathy
Table 1. Characteristics of laser photocoagulation

Study

Type of laser

Type of photocoagulation

Number (size) of burns

Intensity

Exposure time (seconds)

Number of sessions

DRS 1978

Argon

Panretinal

Focal treatment of new vessels

800‐1600 (500 µm) or

500‐1000 (1000 µm)

Not reported

0.1

1 (usually)

ETDRS 1991

Argon

Panretinal

Full: 1200‐1600 (500 µm)

Mild: 400‐650 (500 µm)

Moderate

0.1

Full: 2 or more

Mild: 1

Hercules 1977

Argon

Panretinal

800 to 3000 (200 µm and 500 µm)

Minimal retinal blanching

Not reported

Up to 6

Sato 2012

Not reported

Selective photocoagulation of non‐perfusion areas

(400 µm‐500 µm)

Not reported

Not reported

Yassur 1980

Argon

Panretinal

As for DRS 1978

As for DRS 1978

As for DRS 1978

As for DRS 1978

Figuras y tablas -
Table 1. Characteristics of laser photocoagulation
Comparison 1. Laser photocoagulation versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Loss of 15 or more letters BCVA at 12 months Show forest plot

2

8926

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.89, 1.11]

2 Loss of 15 or more letters BCVA at 2 years Show forest plot

2

8306

Risk Ratio (M‐H, Fixed, 95% CI)

0.88 [0.80, 0.97]

3 Loss of 15 or more letters BCVA at 3 years Show forest plot

2

7458

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.93, 1.23]

4 Severe visual loss (BCVA < 6/60) Show forest plot

4

9276

Risk Ratio (M‐H, Random, 95% CI)

0.46 [0.24, 0.86]

5 Progression of diabetic retinopathy Show forest plot

4

8331

Risk Ratio (M‐H, Random, 95% CI)

0.49 [0.37, 0.64]

6 Vitreous haemorrhage Show forest plot

2

224

Risk Ratio (M‐H, Fixed, 95% CI)

0.56 [0.37, 0.85]

Figuras y tablas -
Comparison 1. Laser photocoagulation versus control