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Cochrane Database of Systematic Reviews

Intervenciones para los trastornos de los movimientos oculares debidos a una lesión cerebral adquirida

Information

DOI:
https://doi.org/10.1002/14651858.CD011290.pub2Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 05 March 2018see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Eyes and Vision Group

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • Fiona J Rowe

    Correspondence to: Department of Health Services Research, University of Liverpool, Liverpool, UK

    [email protected]

  • Kerry Hanna

    Department of Health Services Research, University of Liverpool, Liverpool, UK

  • Jennifer R Evans

    Cochrane Eyes and Vision, ICEH, London School of Hygiene & Tropical Medicine, London, UK

  • Carmel P Noonan

    Department of Ophthalmology, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK

  • Marta Garcia‐Finana

    Biostatistics, University of Liverpool, Liverpool, UK

  • Caroline S Dodridge

    Orthoptics, Oxford University Hospitals NHS Trust, Oxford, UK

  • Claire Howard

    Orthoptics, Salford Royal NHS Foundation Trust, Manchester, UK

  • Kathryn A Jarvis

    Occupational Therapy, University of Liverpool, Liverpool, UK

  • Sonia L MacDiarmid

    Department of Orthoptics, Warrington and Halton Hospitals NHS Foundation Trust, Warrington, UK

  • Tallat Maan

    Community Eye Service, Pennine Care NHS Foundation Trust, Ashton‐under‐Lyne, UK

  • Lorraine North

    Orthoptics, Frimley Park NHS Foundation Trust, Frimley, UK

  • Helen Rodgers

    Institute of Neuroscience, Newcastle University, Newcastle, UK

Contributions of authors

FR proposed the review questions, co‐ordinated the review, organised retrieval of papers and wrote to trial authors for additional information.

FR and KH screened search results, screened retrieved papers against inclusion criteria, appraised quality of papers, extracted data from papers, provided additional data about papers, obtained and screened data on unpublished studies and entered data in Review Manager.

JE provided methodological expertise.

All authors provided additional content expertise, provided clinical, policy and consumer perspectives, read and commented on final drafts of the review.

Sources of support

Internal sources

  • No sources of support supplied

External sources

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

    • NIHR have funded the research fellowship programme that encompasses this Review.

    • Richard Wormald, Co‐ordinating Editor for Cochrane Eyes and Vision (CEV) acknowledges financial support for his CEV research sessions from the Department of Health through the award made by the NIHR 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

Fiona Rowe is an National Institute of Health Research (NIHR) Research Fellow and has received funding from the NIHR to support research relating to visual problems after stroke (including this Cochrane Review).

The work presented here represents the view of the authors and not necessarily those of the funding bodies.

Acknowledgements

Cochrane Eyes and Vision created and executed the electronic search strategies. We thank Catey Bunce and Tracey Shipman for their comments. We thank Anupa Shah and Iris Gordon for their assistance throughout the review process.

Version history

Published

Title

Stage

Authors

Version

2018 Mar 05

Interventions for eye movement disorders due to acquired brain injury

Review

Fiona J Rowe, Kerry Hanna, Jennifer R Evans, Carmel P Noonan, Marta Garcia‐Finana, Caroline S Dodridge, Claire Howard, Kathryn A Jarvis, Sonia L MacDiarmid, Tallat Maan, Lorraine North, Helen Rodgers

https://doi.org/10.1002/14651858.CD011290.pub2

2014 Sep 10

Interventions for eye movement disorders due to acquired brain injury

Protocol

Fiona J Rowe, Carmel P Noonan, Marta Garcia‐Finana, Caroline S Dodridge, Claire Howard, Kathryn A Jarvis, Sonia L MacDiarmid, Tallat Maan, Lorraine North, Helen Rodgers

https://doi.org/10.1002/14651858.CD011290

Differences between protocol and review

Objectives

During the course of doing the review it became clear that it would not make sense to pool data on the pre‐specified different types of interventions (restitutive, substitutive, compensatory and pharmacological) as they are clinically so different. Our original protocol objectives specified a primary objective which implied that these interventions would be pooled, if data were available. We amended our objectives to make it clear that we considered these different groups of interventions separately.

Inclusion criteria

We clarified the following inclusion criteria.

  • Type of studies: we clarified the inclusion of cross‐over trials.

  • Type of participants: we clarified the inclusion of studies of mixed aetiologies.

  • Type of participants: we clarified the exclusion of participants with multiple sclerosis and degenerative conditions.

Search strategy

We amended the search strategy to include additional terms for nystagmus, nerve palsy and gaze disorders.

Amendment to methods

  • Measures of treatment effect: we used the risk ratio rather than the odds ratio as planned, since this provides a better assessment of the treatment effect. Odds ratios are always more exaggerated (larger or smaller) and in this review there were no analytical issues that would warrant using the odds ratio.

  • Assessment of risk of bias: As four out of the five included studies were cross‐over studies, we amended the protocol to include additional 'Risk of bias' assessment criteria for cross‐over studies (Higgins 2011c).

  • GRADE and 'Summary of findings' table: these were not specified in the protocol but we added them because they have since become mandatory Cochrane methods (methods.cochrane.org/mecir).

Planned methods that were not used

  • We did not undertake any meta‐analyses so the following planned methods were not implemented.

  • Measures of treatment effect: we specified the use of the standardised mean difference and also how we would manage change data and final value data but this was not needed.

  • Dealing with missing data: we planned to assess trials that included intention‐to‐treat analyses to ensure this had been done correctly, ensuring participants had been included even if they did not fully adhere to the protocol and that it was possible to extract the appropriate data for these participants from the results.

  • Assessment of heterogeneity: we planned to examine the forest plots and use the Chi2 test and I2 test to assess heterogeneity.

  • Assessment of reporting bias: we planned to create a funnel plot if there were 10 or more trials in any analysis.

  • Data synthesis: we planned to combine data using a random‐effects model (unless there was a small number of trials in which case we would have used a fixed‐effect model).

  • Subgroup analysis: initially we planned to consider the different types of intervention — restitutive, compensatory, substitutive and pharmacological — as subgroup analyses, however in reality but the interventions in these categories were so different we considered that an overall meta‐analysis would be unlikely to be informative (even if the data were available), so we considered these comparisons separately. Other planned subgroup analyses of gender, type of acquired brain injury, side of brain injury, type of eye movement disorder, deviation of eye movement, and severity of eye movement were also not possible.

  • Sensitivity analyses: we planned sensitivity analyses to test the effect of any assumptions regarding missing data, and effects of publication type and risk of bias.

Additional authors

This review includes the authors Kerry Hanna and Jennifer Evans who were not involved in the protocol authorship.

Keywords

MeSH

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

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.
Figures and Tables -
Figure 2

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.
Figures and Tables -
Figure 3

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

Summary of findings for the main comparison. Botulinum toxin versus observation

Botulinum toxin versus observation in people with sixth nerve palsy

Participant or population: people with sixth nerve palsy
Setting: hospital
Intervention: botulinum toxin
Comparison: observation

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with observation

Risk with botulinum toxin

Improvement in ocular motility (ocular alignment ≤ 10 prism dioptres).

Follow‐up to 4 months

800 per 1,000

952 per 1,000
(768 to 1,000)

RR 1.19
(0.96 to 1.48)

47
(1 RCT)

⊕⊕⊝⊝
LOW 1

Achievement of binocular single vision (fusion and stereopsis present).

Follow‐up to 4 months

800 per 1,000

952 per 1,000
(768 to 1,000)

RR 1.19
(0.96 to 1.48)

47
(1 RCT)

⊕⊕⊝⊝
LOW 1

Improvement in functional ability

Not reported

Quality of life

Not reported

Adverse events.

Follow‐up to 4 months

In the injection group only, there were 2/22 (9%) cases of transient ptosis and 4/22 (18%) with transient vertical deviation, with a total complication rate of 24% per injection and 27% per participant. All adverse events recovered within the follow‐up time period of 6 months with no lasting adverse effects.

47

(1 RCT)

⊕⊕⊝⊝
LOW 1

*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).

CI: Confidence interval; 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

1 Downgraded one level for risk of bias (investigators were aware of the randomisation and it was not possible to mask investigators or participants to the allocation and there was variable follow‐up between groups) and downgraded one level for imprecision (confidence intervals include 1, no effect).

Figures and Tables -
Summary of findings for the main comparison. Botulinum toxin versus observation
Summary of findings 2. Pharmacological treatment

Pharmacological treatments (Gabapentin / Baclofen / 3,4‐DAP / 4‐AP) for people with acquired nystagmus

Participant or population: people with acquired nystagmus
Setting: eye clinic
Intervention: pharmacological treatment
Comparison: placebo or other drugs

Comparison

Main findings

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Gabapentin up to 900 mg/day) versus baclofen (up to 30 mg/day).

Follow‐up 2 weeks

Gabapentin may work better than baclofen in improving ocular motility and reducing participant‐reported symptoms (oscillopsia). These effects may be different in pendular and jerk nystagmus but there was no formal subgroup analysis so it is unclear if the difference between the two types of nystagmus was a chance finding. Quality of life was not reported but ten participants with pendular nystagmus chose to continue treatment with gabapentin and one with baclofen. Two participants with jerk nystagmus chose to continue treatment with gabapentin and one with baclofen. Drug intolerance was reported in one person for gabapentin and four participants for baclofen. Increased ataxia was reported in three participants for gabapentin and two participants for baclofen.

21
(1 RCT)

⊕⊝⊝⊝
VERY LOW1

3,4‐DAP (20 mg, single dose) versus placebo.

Assessments made 30 minutes after taking the drug or placebo

3,4‐DAP may reduce the mean peak slow‐phase velocity in people with downbeat nystagmus. In 10 of the 17 participants, mean peak slow‐phase velocity decreased by more than 50% and these 10 people reported having less oscillopsia. No significant adverse events were reported. Nine participants continued treatment. Three participants reported transient side effects of minor perioral/distal paraesthesia.

17
(1 RCT)

⊕⊝⊝⊝
VERY LOW1

4‐AP (10 mg, single dose) versus 3,4‐DAP (10 mg, single dose)

Assessments made at 45 and 90 minutes after taking the drug

3,4 DAP and 4‐AP may reduce mean slow‐phase velocity in people with downbeat nystagmus. This effect may be stronger with 4‐AP. All participants reported mild paraesthesias with both medications.

8
(1 RCT)

⊕⊝⊝⊝
VERY LOW1

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

1 Downgraded two levels for imprecision (due to small number of participants) and one level for serious risk of bias (cross‐over study with analysis that did not permit estimation of effect size).

Figures and Tables -
Summary of findings 2. Pharmacological treatment
Table 1. Botulinum toxin versus observation

Study ID

Total participants

Primary: improved ocular motility

Secondary: improved binocular single vision

Secondary: improved symptoms

Secondary: adverse events

Lee 1994

47, parallel arm RCT

22 ‐ botulinum toxin

25 ‐ observation

6 month follow‐up

21 (95.5%) ‐ botulinum toxin

20 (80%) ‐ observation

Success:

21 (95.5%) ‐ botulinum toxin

20 (80%) ‐ observation

Partial:

3 (12%) ‐ observation

Fail:

1 (4.5%) ‐ botulinum toxin

2 (8%) ‐ observation

21 (95.5%) ‐ botulinum toxin

20 (80%) ‐ observation

9% ptosis

18% vertical deviation

RCT: randomised controlled trial

Figures and Tables -
Table 1. Botulinum toxin versus observation
Table 2. Oculomotor rehabilitation versus sham training

Study ID

Total participants

Primary: improved ocular motility

Secondary: improved functional vision

Secondary: improved symptoms

Secondary: adverse events

Thiagarajan 2014

12, cross‐over RCT

13‐week follow‐up

Baseline 2.1 saccadic ratio reducing to 1.7, P < 0.05 — OM rehabilitation

Control group change not reported

Reading rate:

Baseline 142 (10) wpm improving to 177 (14).

Reading level:

Baseline 4.1 (0.7) grade level improving to 6.3 (1.2), P < 0.01

Fixations per 100 words:

Baseline 164 (10) improving to 135 (11), P = 0.02

Regressions per 100 words:

Baseline 30 (3) improving to 23 (4)

Control group changes not reported

[means (SEM)]

Improved for OM rehabilitation.

Control group changes not reported

Nil reported

SEM: standard error mean
OM: oculo motor
RCT: randomised controlled trial
WPM: words per minute

Figures and Tables -
Table 2. Oculomotor rehabilitation versus sham training
Table 3. Pharmacological treatment for nystagmus

Study ID

Total participants

Primary: improved ocular motility

Secondary: improved visual acuity

Secondary: improved symptoms

Secondary: adverse events

Averbuch‐Heller 1997

21, crossover RCT

15 ‐ pendular

6 ‐ jerk

6‐week trial duration

15 pendular ‐ gabapentin

15 pendular ‐ gabapentin

1 jerk ‐ gabapentin

1 jerk ‐ baclofen

6 pendular ‐ gabapentin

1 jerk ‐ gabapentin

1 jerk ‐ baclofen

1 drug intolerance ‐ gabapentin

4 drug intolerance ‐ baclofen

3 ataxia ‐ gabapentin

2 ataxia ‐ baclofen

Kalla 2011

8, crossover RCT

8 ‐ downbeat

8‐day trial duration

Baseline ‐6.04; 45 mins ‐1.58; 90 mins ‐1.21 (4‐aminopyridine)

Baseline ‐5.68; 45 mins ‐3.29; 90 mins ‐2.96 (3,4‐diaminopyridine)

All with mild paraesthesia

Strupp 2003

17, crossover RCT

17 ‐ downbeat

16‐day trial duration

Baseline 7.2 ± 4.2 °/sec reducing to 3.1 ± 2.5 (3,4‐diaminopyridine)

Baseline 7.4 ± 4.1 °/sec reducing to 7.3 ± 3.7 (placebo)

10 ‐ reduced symptoms (3,4‐diaminopyridine)

0 ‐ reduced symptoms (placebo)

3 ‐ mild paraesthesia (3,4‐diaminopyridine)

1 ‐ nausea/headache (3,4‐diaminopyridine)

RCT: randomised controlled trial

Figures and Tables -
Table 3. Pharmacological treatment for nystagmus