Table 3.

Safety events (index eye where ocular). Values are numbers (percentages)

Events	Trabeculectomy (n=227)	Medical management (n=226)
No of participants with safety event	88 (39)	100 (44)
Serious adverse events
No of participants	12/226 (5)	8/226 (4)
No of events	13	8
Details:
Death	5	4
Life threatening	0	1
Hospital admission	3	4
Significant disability	2	0
Important condition	3	1
Expected event	3	2
Classification:
General medical (death)	2	4
Unclassified (death)	3	0
General medical	2	3
Related to glaucoma surgery	3	1
General ophthalmology	1	0
Non-glaucoma vision loss	1	0
Glaucoma progression despite treatment	1	0
Adverse events
No of participants	84/222 (38)	93/221 (42)
No of events	139	155
Details:
Drop related*	18	83
Ocular surface related†	29	37
Non-specific‡	19	17
Early bleb leak	12	3
Hypotony (<6 mm Hg) requiring intervention	11	3
Choroidal effusion	9	2
Shallow anterior chamber	7	2
Ptosis	5	1
Hyphema	4	0
Late bleb leak	4	0
Potential adverse event related to surgery	3	1
Cataract	1	2
Conjunctival buttonhole	3	0
Corneal epithelial defect	3	0
Glaucoma progression	1	2
Irreversible loss of ≥10 ETDRS letters§	3	0
Blebitis	2	0
Suprachoroidal haemorrhage	2	0
Endophthalmitis§—endogenous	1	0
Endophthalmitis§—bleb related	0	1
Persistent uveitis	1	0
Macular oedema	0	1
Non-specific unrelated uveitis	1	0

ETDRS=Early Diabetic Treatment Diabetic Retinopathy Study.

^*Includes drop allergy, drop intolerance, periorbital skin pigmentation, taste disturbance.

^†Includes dry eye, blepharitis, meibomitis, corneal epitheliopathy, conjunctivitis, itchy eye, watering eyes.

^‡Non-specific blurred vision, retinal vascular occlusion, vitreomacular traction, chalazion, subconjunctival haemorrhage.

^§Also recorded as a serious adverse event.