Table 6.
Adverse events
|
Eye drop group (n=362) |
SLT (n=356) |
Total (n=718) |
||||||
|---|---|---|---|---|---|---|---|---|
| Number of events | Number of patients (%) | Number of events | Number of patients (%) | Number of events | Number of patients (%) | |||
| Adverse events | 1196 | 260 (71·8%) | 906 | 261 (73·3%) | 2096 | 521 (72·6%) | ||
| Ocular | ||||||||
| Aesthetic side effects of medication* | 117 | 56 (15·5%) | 12 | 7 (2·0%) | 129 | 63 (8·8%) | ||
| Ophthalmic allergic reactions† | 33 | 17 (4·7%) | 18 | 13 (3·7%) | 51 | 30 (4·2%) | ||
| Reactivation of herpes simplex keratitis | 1 | 1 (0·3%) | 1 | 1 (0·3%) | 2 | 2 (0·3%) | ||
| Uveitis | 1 | 1 (0·3%) | 2 | 2 (0·6%) | 3 | 3 (0·4%) | ||
| Other‡ | 744 | 221 | 459 | 186 | 1203 | 407 | ||
| SLT-related ocular | ||||||||
| Inflammation after SLT | 0 | 0 (0%) | 1 | 1 (0·3%) | 1 | 1 (0·1%) | ||
| IOP spike after SLT§ | 0 | 0 | 6 | 6 (1.7%) | 6 | 6 (0·8%) | ||
| Other transient events¶ | 2 | 1 (0·3%) | 171 | 122 (34·4%) | 173 | 123 (17·2%) | ||
| Patients with an adverse event during SLT procedure|| | ·· | 0 | ·· | 14 (3·9%) | ·· | 14 (1·9%) | ||
| Systemic** | ||||||||
| Pulmonary problems†† | 23 | 14 (3·9%) | 24 | 12 (3·4%) | 47 | 26 (3·6%) | ||
| Cardiac events | 6 | 5 (1·4%) | 8 | 5 (1·4%) | 14 | 10 (1·4%) | ||
| Drug-related events‡‡ | 148 | 52 (14·4%) | 87 | 23 (6·5%) | 235 | 75 (10·5%) | ||
| Other§§ | 121 | 82 (22·7%) | 117 | 78 (22%) | 238 | 160 (22·3%) | ||
| Serious adverse events | 95 | 68 (18·8%) | 107 | 64 (18·0%) | 202 | 132 (18·4%) | ||
| Ocular¶¶ | 7 | 6 (1·7%) | 10 | 8 (2·2%) | 17 | 14 (1·9%) | ||
| Pulmonary problems|||| | 3 | 3 (0·8%) | 2 | 2 (0·5%) | 5 | 5 (0·7%) | ||
| Cerebrovascular accidents | 1 | 1 (0·3%) | 2 | 2 (0·5%) | 3 | 3 (0·4%) | ||
| Cardiac events | 7 | 7 (1·9%) | 9 | 8 (2·2%) | 16 | 15 (2·1%) | ||
| Cancer | 9 | 8 (2·2%) | 15 | 13 (3·6%) | 24 | 21 (2·9%) | ||
| Death | 2 | 2 (0·5%) | 8 | 8 (2·2%) | 10 | 10 (1·4%) | ||
| Other systemic | 66 | 50 (15·3%) | 61 | 43 (12·1%) | 127 | 93 (13%) | ||
SLT=selective laser trabeculoplasty. IOP=intraocular pressure.
Includes excessive lash growth, peri-ocular pigmentation, change in iris colour.
Includes peri-ocular skin rash.
Includes ocular irritation, discomfort, dry eye, retinal haemorrhages, vision changes, flashes, floaters, conjunctivitis, blepharitis, vascular occlusions, diabetic retinopathy, macular pathology.
IOP spike defined as >5 mm Hg; only one eye received treatment.
Includes discomfort, transient blurred vision, transient photophobia, hyperaemia.
Includes discomfort, variation in the number of laser shots, angle visualisation issues.
Not requiring hospital admission.
Asthma, shortness of breath, reduced exercise tolerance.
includes impotence, depression, somnolence or tiredness, nightmares, taste disturbance, generalised skin rash.
Unrelated events, such as headaches, pain, falls.
Includes central retinal artery occlusion, choroidal neovascularisation, epiretinal membrane, angle closure, anterior chamber surgery, corneal pathologies, trauma, and any treatment required for these pathologies.
Requiring hospital admission.