Common Terminology Criteria for Adverse Events - Instructions and Guidelines
Common Terminology Criteria for Adverse Events - Instructions and Guidelines
For AEs that include an ophthalmologic measure of visual acuity for grading, the patient’s visual acuity prior to the intervention should be considered.
Changes to AEs in this CATEGORY (from CTC v2.0 to CTCAE v3.0)
|
Cataract |
Grades 2 and 3 revised |
|
Conjunctivitis |
Name revised to Ocular surface diseases |
|
Dry eye |
Name revised to Dry eye syndrome; Grade 3 added; Grade 2 revised |
|
Eyelid dysfunction |
New AE |
|
Glaucoma |
Grades 1-4 revised |
|
Keratitis (corneal inflammation/ corneal ulceration) |
No change |
|
Nystagmus |
Original v2.0 location in the NEUROLOGY CATEGORY |
|
Optic disc edema |
New AE |
|
Proptosis/enophthalmos |
New AE |
|
Retinal detachment |
New AE |
|
Retinopathy |
New AE |
|
Scleral necrosis/melt |
New AE |
|
Tearing (watery eyes) |
Name revised to Watery eye (epiphora, tearing) |
|
Uveitis |
New AE |
|
Vision-blurred vision |
Grades 1 and 4 added |
|
Vision-double vision (diplopia) |
Name revised to Ophthalmoplegia/diplopia (double vision); Grades 1 and 4 added |
|
Vision-flashing lights/floaters |
Grade 4 added |
|
Vision-night blindness (nyctalopia) |
Name revised to Night blindness Nyctalopia; Grade 4 added; Grade 1 revised |
|
Vision-photophobia |
Grade 4 added; Grade 1 revised |
|
Vitreous hemorrhage |
New AE |
|
Ocular/Visual – Other (Specify, ___) |
No change |
Prepared by CTIS, Inc.