Summary of findings 1. Silicone hydrogel versus hydrogel soft contact lenses for differences in patient‐reported comfort and safety.
| Silicone hydrogel versus hydrogel soft contact lenses for differences in patient‐reported comfort and safety | ||||||
|
Patient or population: adults with refractive errors Settings: community private practices or university‐affiliated eye clinics Intervention: silicone hydrogel soft contact lenses (Balafilcon A, Comfilcon A, Delefilcon A, Galyfilcon A, Lotrafilcon A, Lotrafilcon B, Narafilcon A, Senofilcon A) Comparison: hydrogel soft contact lenses (Etafilcon A, Nelfilcon A, Ocufilcon B) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) |
Relative effect (95% CI) |
No. of participants (studies) |
Certainty of evidence (GRADE) |
Comments | |
|
Assumed risk hydrogel |
Corresponding risk silicone hydrogel |
|||||
| Mean change in patient‐reported comfort score from baseline using CLDEQ‐8 | No studies assessed this outcome. | |||||
|
Mean change in patient‐reported comfort score from baseline using OSDI, at 1 month (MD < 0 favored) |
23.44 (SD 17) | 22.24 (12.95 to 31.53) | MD −1.20 (−10.49 to 8.09) |
47 (1 RCT) |
⊕⊝⊝⊝ Very low1,2 |
Results reported at 3 months for this RCT were similar (MD 1.43, 95% CI −8.05 to 10.91). |
|
Mean change in patient‐reported comfort score from baseline using VAS, at 1 week (MD > 0 favored) |
3.35 (SD 1.5) | 3.9 (3.51 to 4.29) | MD 0.55 (0.16 to 0.94) |
240 (1 RCT) |
⊕⊝⊝⊝ Very low3,4 |
VAS 0 to 5; 5 = excellent comfort |
|
Proportion of participants who discontinued contact lens wear, at 1 week (RR < 1 favored) |
25 per 1000 | 16 (3 to 94) per 1000 | RR 0.64 (0.11 to 3.74) |
248 (1 RCT) |
⊕⊝⊝⊝ Very low1,2 |
Pooled results by adding data from 4 other RCTs with follow‐up time up to 52 weeks (total n = 1273) were similar (RR 0.92, 95% CI 0.73 to 1.16). |
|
Corneal staining scores, at 1 week (MD < 0 favored) |
0.56 (SD 0.43) | 0.31 (0.20 to 0.42) | MD −0.25 (−0.36 to −0.14) |
243 (1 RCT) |
⊕⊝⊝⊝ Very low3,4 |
≥ 0.5 units clinically meaningful (Dundas 2001) NEI grading scale5 |
|
Conjunctival staining scores, at 1 month (MD < 0 favored) |
0.3 (SD 0.5) | 0.5 (0.28 to 0.72) | MD 0.20 (−0.02 to 0.42) |
80 (1 RCT) |
⊕⊝⊝⊝ Very low3,4 |
≥ 0.5 units clinically meaningful (Dundas 2001) 5‐point scale6 |
|
Proportion of participants with vision‐threatening adverse events (RR < 1 favored) |
4 weeks |
⊕⊝⊝⊝ Very low1,2 |
||||
| 5 per 1000 | 3 (0 to 28) per 1000 | RR 0.68 (0.08 to 5.51) |
368 (2 RCTs) |
|||
| 3 months | ||||||
| 50 per 1000 | 178 (10 to 1000) per 1000 | RR 3.56 (0.19 to 66.72) |
90 (1 RCT) |
|||
| 52 weeks | ||||||
| 271 per 1000 | 550 (374 to 810) per 1000 | RR 2.03 (1.38 to 2.99) |
815 (2 RCTs) |
|||
| *The basis for the assumed risk is the mean baseline risk from the studies in the meta‐analysis; the total number of events in the control group divided by the total number of participants in the control groups, scaled to 1000. 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; CLDEQ‐8, Contact Lens Dry Eye Questionnaire‐8; MD, mean difference; NEI, National Eye Institute; OSDI, Ocular Surface Disease Index; RCT, randomized controlled trial; RR, risk ratio; SD, standard deviation; VAS, visual analog scale | ||||||
| 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. | ||||||
1Downgraded for risk of bias (−1). 2Downgraded for extreme imprecision (−2). 3Downgraded for high risk of bias (−2). 4Downgraded for imprecision (−1). 5NEI grading scale 0 to 3; 0 = normal, 1 = mild, 2 = moderate, 3 = severe; inferior region only. 65‐point scale 0 to 4; 0 = none, 4 = severe; scores were averages of quadrants.