Table 13.
Summary of Study Eye Ocular Adverse Events through 56-Week Visit of Follow-up
| Sham+ Focal/Grid/PRP Laser | Ranibizumab+ Focal/Grid/PRP Laser | Triamcinolone+ Focal/Grid/PRP Laser | |
|---|---|---|---|
|
| |||
| Total Number of Events | N = 277 | N = 242 | N = 255 |
| Anterior chamber | |||
| Anterior chamber cell | 0 | 0 | 1 |
| Corneal dystrophy | 0 | 0 | 1 |
| Hyphaema | 1 | 2 | 0 |
| Cataract | |||
| Cataract nuclear | 1 | 0 | 1 |
| Cataract operation | 1 | 0 | 2 |
| Conjunctiva | |||
| Conjunctival haemorrhage | 5 | 13 | 10 |
| Conjunctival hyperaemia | 1 | 0 | 1 |
| Conjunctivitis | 0 | 1 | 0 |
| Dry eye | 2 | 2 | 1 |
| Eye discharge | 1 | 2 | 0 |
| Keratoconjunctivitis sicca | 0 | 1 | 1 |
| Pinguecula | 0 | 0 | 1 |
| Cornea | |||
| Corneal abrasion | 1 | 0 | 0 |
| Corneal defect | 1 | 1 | 1 |
| Corneal epithelium defect | 1 | 0 | 0 |
| Corneal oedema | 1 | 0 | 0 |
| Corneal pigmentation | 1 | 0 | 0 |
| Punctate keratitis | 4 | 1 | 0 |
| External | |||
| Eye irritation | 8 | 7 | 1 |
| Lacrimation increased | 4 | 3 | 1 |
| Glaucoma-IOP | |||
| Angle closure glaucoma | 0 | 0 | 1 |
| Borderline glaucoma | 0 | 0 | 1 |
| Glaucoma | 1 | 2 | 2 |
| Ocular hypertension | 0 | 0 | 1 |
| Inflammation | |||
| Iritis | 1 | 0 | 3 |
| Iris | |||
| Iris bombe | 0 | 1 | 0 |
| Lens | |||
| Cataract | 4 | 2 | 9 |
| Cataract cortical | 2 | 3 | 1 |
| Cataract subcapsular | 0 | 2 | 9 |
| Posterior capsule | |||
| opacification | 0 | 1 | 1 |
| Lids | |||
| Blepharitis | 4 | 3 | 2 |
| Chalazion | 1 | 0 | 0 |
| Erythema of eyelid | 0 | 0 | 1 |
| Eyelid oedema | 2 | 1 | 2 |
| Eyelid ptosis | 0 | 1 | 0 |
| Miscellaneous-eye | |||
| Ocular hyperaemia | 3 | 2 | 3 |
| Photopsia | 2 | 2 | 0 |
| Sinusitis | 1 | 0 | 0 |
| Foreign body in eye | 0 | 1 | 3 |
| Intraocular pressure increased | 8 | 9 | 18 |
| Iris neovascularisation | 8 | 1 | 2 |
| Neovascularisation | 2 | 0 | 2 |
| Cutis laxa | 0 | 0 | 2 |
| Ecchymosis | 0 | 0 | 1 |
| Eyelid erosion | 0 | 0 | 1 |
| Herpes virus infection | 0 | 1 | 0 |
| Injection site discomfort | 0 | 1 | 0 |
| Corneal dystrophy | 0 | 0 | 1 |
| Visual impairment | 3 | 4 | 5 |
| Optic nerve | |||
| Optic disc disorder | 0 | 0 | 1 |
| Retina | |||
| Diabetic retinal oedema | 3 | 3 | 0 |
| Diabetic retinopathy | 2 | 1 | 1 |
| Macular degeneration | 0 | 0 | 2 |
| Macular ischaemia | 0 | 0 | 1 |
| Macular oedema | 1 | 0 | 3 |
| Maculopathy | 11 | 12 | 9 |
| Retinal degeneration | 1 | 1 | 0 |
| Retinal detachment | 10 | 6 | 3 |
| Retinal exudates | 1 | 2 | 1 |
| Retinal haemorrhage | 3 | 4 | 1 |
| Retinal neovascularisation | 5 | 1 | 4 |
| Retinal pigment epitheliopathy | 0 | 0 | 1 |
| Retinal tear | 0 | 1 | 0 |
| Subretinal fibrosis | 0 | 0 | 1 |
| Vitreous adhesions | 0 | 0 | 1 |
| Sensation-pain | |||
| Abnormal sensation in eye | 3 | 3 | 1 |
| Eye pain | 19 | 19 | 14 |
| Eye pruritus | 9 | 2 | 2 |
| Eyelid pain | 0 | 1 | 0 |
| Foreign body sensation in eyes | 4 | 4 | 2 |
| Strabismus | |||
| Extraocular muscle paresis | 0 | 1 | 1 |
| Visual field | |||
| Visual field defect | 1 | 1 | 0 |
| Visual symptoms/abnormality | |||
| Amaurosis fugax | 1 | 0 | 0 |
| Diplopia | 2 | 5 | 1 |
| Halo vision | 1 | 0 | 0 |
| Photophobia | 7 | 4 | 8 |
| Photopsia | 4 | 9 | 3 |
| Vision blurred | 22 | 17 | 22 |
| Visual acuity reduced | 8 | 4 | 9 |
| Visual disturbance | 1 | 4 | 2 |
| Visual impairment | 4 | 5 | 3 |
| Vitreous | |||
| Endophthalmitis | 0 | 1 | 0 |
| Myodesopsia | 16 | 13 | 16 |
| Vitreous detachment | 4 | 3 | 1 |
| Vitreous disorder | 2 | 0 | 1 |
| Vitreous floaters | 7 | 9 | 13 |
| Vitreous haemorrhage | 47 | 35 | 33 |
| Vitreous opacities | 2 | 0 | 1 |
| Vitrectomy | 1 | 1 | 0 |
PRP=Panretinal photocoagulation