Summary of findings 1. Steroids compared with lubricants.
| Steroid treatment compared with lubricant (artificial tears alone or with tobramycin, vehicle, or no treatment) for dry eye | ||||||
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Patient or population: people with dry eye Setting: eye clinics or medical centers Intervention: steroid alone (clobetasone, difluprednate, loteprednol etabonate, fluorometholone, corticosteroid) or in combination with tobramycin Comparison: artificial tears (including hyaluronate, PVP, Soothe Emollient), vehicle, no treatment, or artificial tears with tobramycin | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) |
Relative effect (95% CI) |
No. of participants (studies) |
Certainty of the evidence (GRADE) |
Comments | |
|
Assumed risk Artificial tears |
Corresponding risk Steroid intervention |
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Change in patient‐reported symptom scores (lower is favored) |
Change in symptom scores in the steroid groups was on average 0.29 SMD (95% CI 0.16 to 0.42) lower than in the artificial tears groups. |
SMD −0.29 (95% CI −0.42 to −0.16) |
3654 (15) | ⊕⊕⊕⊝ Moderate1 | As suggested in Cohen 1988, 0.2 SMD represents a small difference, and 0.5 a moderate difference. | |
| Change in patient‐reported quality of life scores | No studies measured this outcome. | ‐ | ‐ | ‐ | ||
|
Change in TBUT (seconds) (longer is favored) |
Change in TBUT in the steroid groups was on average 0.70 (95% CI 0.06 to 1.34) longer than in the artificial tears groups. |
MD 0.70 (95% CI 0.06 to 1.34) |
587 (7) | ⊕⊕⊝⊝ Low1,2 | MID 5 s (Wolffsohn 2017) | |
|
Change in fluorescein corneal staining scores (lower is favored) |
Change in fluorescein corneal staining scores in the steroid groups was on average 0.40 SMD (95% CI 0.18 to 0.62) lower than in the artificial tears groups. |
SMD −0.40 (95% CI −0.62 to −0.18) |
3583 (15) | ⊕⊕⊕⊝ Moderate1 | As suggested in Cohen 1988, 0.2 SMD represents a small difference, and 0.5 a moderate difference. | |
|
Change in tear osmolarity (mOsm/kg) (lower is favored) |
336.9 (SD 22.23) | 338.5 (SD 15.81) |
MD 1.60 (95% CI −10.47 to 13.67) |
40 (1) | ⊕⊝⊝⊝ Very low3,4 | MID 5 mOsm/L (Wolffsohn 2017) |
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Adverse effect: incident elevated IOP (follow‐up 14 days to 2 months) |
9 incidents per 10,000 participants |
54 incidents (95% CI 12 to 246) per 10,000 participants |
RR 5.96 (95% CI 1.30 to 27.38) |
2264 (8) | ⊕⊝⊝⊝ Very low3,4 | |
|
Adverse effect: new cataract formation (follow‐up 14 days to 4 weeks) |
16 incidents per 10,000 participants |
5 incidents (95% CI 0.2 to 132) per 10,000 participants |
RR 0.34 (95% CI 0.01 to 8.22) |
1205 (3) | ⊕⊝⊝⊝ Very low3,4 | |
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and the associated 95% CI). CI, confidence interval; IOP, intraocular pressure; MD, mean difference; MID, minimally important difference; mOsm, milliosmoles; PVP, polyvinylpyrrolidone; RR, risk ratio; SD, standard deviations; SMD, standardized mean difference; TBUT, tear film break‐up time | ||||||
| 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 for risk of bias (−1). 2 Downgraded for unexplained heterogeneity (−1). 3 Downgraded for imprecision (−1). 4 Downgraded for high risk of bias (−2).