Table 6.
Primary outcomes from baseline – Adverse Events
| Outcome | Comparison | Number of subjects (primary studies) | Measure of effect (95% CI) | Direction of effect | I2 (%) |
|---|---|---|---|---|---|
| Allergic or hypersensitivity reactions or discomfort | 1% atropine versus control | 446 (2) | OR = 8.91 (1.04, 76.03) | Favours control | 0 |
| Blurred near vision | 1% atropine versus control | 540 (2) | OR = 9.47 (1.17, 76.78) | Favours control | 0 |
| Contact lens-related discomfort/Unwillingness to wear contact lenses | Concentric ring bifocal SCLs versus SVSCLs | 261 (2) | OR = 0.95 (0.49, 1.81) | Favours concentric ring bifocal SCLs | 0 |
| Mild corneal erosion | ΟΚ versus SCLs or SVLs | 151 (2) | 0R = 4.56 (0.49, 42.25) | Favours SCLs/SVLs | 0 |
| Papillae/Follicles | 2% pirenzepine gel versus control | 323 (3) | OR = 3.21 (0.95, 10.88) | Favours control | 74 |
| Medication residue on eyelids or eye | 2% pirenzepine gel versus control | 323 (3) | OR = 0.77 (0.38, 1.59) | Favours pirenzepine | 33 |
| Abnormality of accommodation | 2% pirenzepine gel versus control | 323 (3) | OR = 16.92 (6.27, 45.64) | Favours control | 0 |
| Itching, eye | 2% pirenzepine gel versus control | 323 (3) | OR = 1.01 (0.54, 1.90) | No difference | 0 |
| Visual acuity decreased (subjectively) | 2% pirenzepine gel versus control | 323 (3) | OR = 3.89 (0.93, 16.27) | Favours control | 33 |
| Injection | 2% pirenzepine gel versus control | 323 (3) | OR = 0.92 (0.22, 3.73) | Favours pirenzepine | 74 |
| Fluorescein staining | 2% pirenzepine gel versus control | 323 (3) | OR = 0.57 (0.23, 1.44) | Favours pirenzepine | 45 |
| Burn/Sting, eye, on instillation | 2% pirenzepine gel versus control | 323 (3) | OR = 1.84 (0.76, 4.46) | Favours control | 0 |
| Eye/Vision, blurred | 2% pirenzepine gel versus control | 323 (3) | OR = 1.17 (0.52, 2.63) | Favours control | 0 |
| Erythema, eyelids | 2% pirenzepine gel versus control | 110 (2) | OR = 0.69 (0.01, 41.23) | Favours pirenzepine | 76 |
| Eyelid abnormality | 2% pirenzepine gel versus control | 110 (2) | OR = 1.73 (0.27, 11.12) | Favours control | 0 |
| Photophobia | 2% pirenzepine gel versus control | 110 (2) | OR = 1.57 (0.35, 6.96) | Favours control | 0 |
| Eye pain | 2% pirenzepine gel versus control | 110 (2) | OR = 2.07 (0.33, 12.98) | Favours control | 0 |
| Cough, increased | 2% pirenzepine gel versus control | 323 (3) | OR = 1.06 (0.59, 1.92) | No difference | 0 |
| Infection, respiratory | 2% pirenzepine gel versus control | 297 (2) | OR = 1.32 (0.69, 2.51) | Favours control | 0 |
| Rhinitis/Sinusitis | 2% pirenzepine gel versus control | 323 (3) | OR = 1.08 (0.42, 2.76) | No difference | 28 |
| Fever | 2% pirenzepine gel versus control | 297 (2) | OR = 1.07 (0.51, 2.24) | No difference | 0 |
| Abdominal pain | 2% pirenzepine gel versus control | 323 (3) | OR = 2.42 (0.88, 6.62) | Favours control | 0 |
| Headache | 2% pirenzepine gel versus control | 323 (3) | OR = 1.30 (0.66, 2.56) | Favours control | 0 |
| Flu syndrome | 2% pirenzepine gel versus control | 297 (2) | OR = 0.54 (0.26, 1.13) | Favours pirenzepine | 0 |
| Pharyngitis | 2% pirenzepine gel versus control | 323 (3) | OR = 1.07 (0.48, 2.37) | No difference | 0 |
| Rash/Allergic reaction | 2% pirenzepine gel versus control | 323 (3) | OR = 1.77 (0.51, 6.12) | Favours control | 22 |
| Cold, common | 2% pirenzepine gel versus control | 110 (2) | OR = 0.60 (0.25, 1.42) | Favours pirenzepine | 0 |
| Accidental injury | 2% pirenzepine gel versus control | 110 (2) | OR = 2.32 (0.74, 7.22) | Favours control | 0 |
CI confidence interval, OK Orthokeratology, OR odds ratio, RR risk ratio, SCLs soft contact lenses, SVLs single vision lenses, SVSCLs single vision soft contact lense