Number and calculated percentages of clustered adverse reactions stratified by cycloplegic eye drop treatment and their distribution across age and BMI categories
| C+C* | ||||||||
|---|---|---|---|---|---|---|---|---|
| 3–6 years | 7–10 years | 11–14 years | ||||||
| n | AR‡ n(%) | n | AR‡ n(%) | n | AR‡ n(%) | n | AR‡ n(%) | |
| Complaint | ||||||||
| Severe or moderate drowsiness§ | 408 | 22 (5.4) | 163 | 18 (11.0) | 158 | 2 (1.3) | 87 | 2 (2.3) |
| Mild drowsiness or apathy§ | 408 | 10 (2.5) | 163 | 9 (5.5) | 158 | 1 (0.6) | 87 | 0 |
| Excitation, hyperactivity and/or behavioural problems§ | 408 | 6 (1.5) | 163 | 6 (3.7) | 158 | 0 | 87 | 0 |
| Dizziness§ | 408 | 2 (0.5) | 163 | 0 | 158 | 0 | 87 | 2 (2.3) |
| Red cheeks or face (feverish, flushing)¶ | 408 | 2 (0.5) | 163 | 1 (0.6) | 158 | 1 (0.6) | 87 | 0 |
| Nose bleeding¶ | 408 | 0 | 163 | 0 | 158 | 0 | 87 | 0 |
| BMI | ||||||||
| Severe or moderate drowsiness | ||||||||
| Low BMI | 18 | 13 (72.2) | 13 | 11 (84.6) | 3 | 1 (33.3) | 2 | 1 (50.0) |
| Normal BMI | 292 | 9 (3.1) | 125 | 7 (5.6) | 104 | 1 (1.0) | 63 | 1 (1.6) |
| High BMI | 98 | 0 | 25 | 0 | 51 | 0 | 22 | 0 |
| Mild drowsiness or apathy | ||||||||
| Low BMI | 18 | 0 | 13 | 0 | 3 | 0 | 2 | 0 |
| Normal BMI | 292 | 10 (3.4) | 125 | 9 (7.2) | 104 | 1 (1.0) | 63 | 0 |
| High BMI | 98 | 0 | 25 | 0 | 51 | 0 | 22 | 0 |
| Excitation, hyperactivity and/or behavioural problems | ||||||||
| Low BMI | 18 | 0 | 13 | 0 | 3 | 0 | 2 | 0 |
| Normal BMI | 292 | 5 (1.7) | 125 | 5 (4.0) | 104 | 0 | 63 | 0 |
| High BMI | 98 | 1 (1.0) | 25 | 1 (4.0) | 51 | 0 | 22 | 0 |
| Dizziness | ||||||||
| Low BMI | 18 | 0 | 13 | 0 | 3 | 0 | 2 | 0 |
| Normal BMI | 292 | 2 (2.0) | 125 | 0 | 104 | 0 | 63 | 2 (3.2) |
| High BMI | 98 | 0 | 25 | 0 | 51 | 0 | 22 | 0 |
| Red cheeks or face (feverish, flushing) | ||||||||
| Low BMI | 18 | 0 | 13 | 0 | 3 | 1 (33.3) | 2 | 0 |
| Normal BMI | 292 | 2 (2.0) | 125 | 1 (0.8) | 104 | 0 | 63 | 0 |
| High BMI | 98 | 0 | 25 | 0 | 51 | 0 | 22 | 0 |
| Nose bleeding | ||||||||
| Low BMI | 18 | 0 | 13 | 0 | 3 | 0 | 2 | 0 |
| Normal BMI | 292 | 0 | 125 | 0 | 104 | 0 | 63 | 0 |
| High BMI | 98 | 0 | 25 | 0 | 51 | 0 | 22 | 0 |
| C+C | ||||||||
| 3–6 years | 7–10 years | 11–14 years | ||||||
| n | AR‡ n(%) | n | AR‡ n(%) | n | AR‡ n(%) | n | AR‡ n(%) | |
| Complaint | ||||||||
| Severe or moderate drowsiness§ | 504 | 8 (1.6) | 200 | 6 (3.0) | 191 | 1 (0.5) | 113 | 1 (0.9) |
| Mild drowsiness or apathy§ | 504 | 11 (2.2) | 200 | 4 (2.0) | 191 | 5 (2.6) | 113 | 2 (1.8) |
| Excitation, hyperactivity and/or behavioural problems§ | 504 | 3 (0.6) | 200 | 3 (1.5) | 191 | 0 | 113 | 0 |
| Dizziness§ | 504 | 0 | 200 | 0 | 191 | 0 | 113 | 0 |
| Red cheeks or face (feverish, flushing)¶ | 504 | 1 (0.2) | 200 | 1 (0.5) | 191 | 0 | 113 | 0 |
| Nose bleeding¶ | 504 | 1 (0.2) | 200 | 1 (0.5) | 191 | 0 | 113 | 0 |
| BMI | ||||||||
| Severe or moderate drowsiness | ||||||||
| Low BMI | 29 | 5 (17.2) | 14 | 3 (21.4) | 9 | 1 (11.1) | 6 | 1 (16.7) |
| Normal BMI | 366 | 3 (8.2) | 157 | 3 (1.9) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Mild drowsiness or apathy | ||||||||
| Low BMI | 29 | 5 (17.2) | 14 | 1 (7.1) | 9 | 2 (22.2) | 6 | 2 (33.3) |
| Normal BMI | 366 | 6 (1.6) | 157 | 3 (1.9) | 129 | 3 (2.3) | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Excitation, hyperactivity and/or behavioural problems | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 2 (0.6) | 157 | 2 (1.3) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 1 (0.9) | 29 | 1 (3.0) | 53 | 0 | 27 | 0 |
| Dizziness | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 0 | 157 | 0 | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Red cheeks or face (feverish, flushing) | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 1 (0.3) | 157 | 1 (0.6) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Nose bleeding | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 1 (0.3) | 157 | 1 (0.6) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| C+T | ||||||||
| 3–6 years | 7–10 years | 11–14 years | ||||||
| n | AR‡ n(%) | n | AR‡ n(%) | n | AR‡ n(%) | n | AR‡ n(%) | |
| Complaint | ||||||||
| Severe or moderate drowsiness§ | 504 | 8 (1.6) | 200 | 6 (3.0) | 191 | 1 (0.5) | 113 | 1 (0.9) |
| Mild drowsiness or apathy§ | 504 | 11 (2.2) | 200 | 4 (2.0) | 191 | 5 (2.6) | 113 | 2 (1.8) |
| Excitation, hyperactivity and/or behavioural problems§ | 504 | 3 (0.6) | 200 | 3 (1.5) | 191 | 0 | 113 | 0 |
| Dizziness§ | 504 | 0 | 200 | 0 | 191 | 0 | 113 | 0 |
| Red cheeks or face (feverish, flushing)¶ | 504 | 1 (0.2) | 200 | 1 (0.5) | 191 | 0 | 113 | 0 |
| Nose bleeding¶ | 504 | 1 (0.2) | 200 | 1 (0.5) | 191 | 0 | 113 | 0 |
| BMI | ||||||||
| Severe or moderate drowsiness | ||||||||
| Low BMI | 29 | 5 (17.2) | 14 | 3 (21.4) | 9 | 1 (11.1) | 6 | 1 (16.7) |
| Normal BMI | 366 | 3 (8.2) | 157 | 3 (1.9) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Mild drowsiness or apathy | ||||||||
| Low BMI | 29 | 5 (17.2) | 14 | 1 (7.1) | 9 | 2 (22.2) | 6 | 2 (33.3) |
| Normal BMI | 366 | 6 (1.6) | 157 | 3 (1.9) | 129 | 3 (2.3) | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Excitation, hyperactivity and/or behavioural problems | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 2 (0.6) | 157 | 2 (1.3) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 1 (0.9) | 29 | 1 (3.0) | 53 | 0 | 27 | 0 |
| Dizziness | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 0 | 157 | 0 | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Red cheeks or face (feverish, flushing) | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 1 (0.3) | 157 | 1 (0.6) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
| Nose bleeding | ||||||||
| Low BMI | 29 | 0 | 14 | 0 | 9 | 0 | 6 | 0 |
| Normal BMI | 366 | 1 (0.3) | 157 | 1 (0.6) | 129 | 0 | 80 | 0 |
| High BMI | 109 | 0 | 29 | 0 | 53 | 0 | 27 | 0 |
*C+C: Two drops of cyclopentolate 1%.
†C+T: One drop of cyclopentolate 1% followed by one drop of tropicamide 1%.
‡AR: Adverse reactions.
§CNS adverse reactions.
¶Peripheral adverse reactions.
BMI, body mass index.