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Study flow diagram
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Figure 1

Study flow diagram

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

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

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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 3

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

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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).

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

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Summary of findings 2. Pharmacological treatment
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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
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Table 1. Botulinum toxin versus observation
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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

Figuras y tablas -
Table 2. Oculomotor rehabilitation versus sham training
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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
Figuras y tablas -
Table 3. Pharmacological treatment for nystagmus
Ir a la tabla de la revisión