Summary of determinant (ie, validated) and contributory (ie, indicative) diagnostic criteria and grading recommended by the ODISSEY panel to be used to establish severe DED in the case of symptom and sign discordance (ie, scenario A, B, or C)
| Criteria type | Evaluations | Scenario A | Scenario B | Scenario C |
|---|---|---|---|---|
| Determinant Criteria | Schirmer test: <3 mm | X | X | X |
| MGD or eyelid inflammation: severe | X | X | X | |
| Conjunctival staining (also conjunctivochalasis/conjunctival folds: severe degree | X | X | X | |
| Impaired visual function (photophobia, visual acuity modifications, low contrast sensitivity, or any combination of the above) | X | X | X | |
| Filamentary keratitis | X | X | NA* | |
| Blepharospasm | X | X | X | |
| Hyperosmolarity: >328 mOsm/L | X | X | X | |
| Impression cytology: ≥grade 3 (Nelson Scale) | X | X | X | |
| Corneal sensitivity: deeply impaired | X | NA†2 | NA† | |
| Contributory Criteria | TBUT <3 s | X | X | NA‡ |
| Refractory to standard disease treatments | X | X | X | |
| Aberrometry | X | X | X | |
| Confocal microscopy | X | X | X | |
| Inflammatory markers: HLA-DR, MMP9, cytokines and proteomics | X | X | X |
Criteria are ranked (highest to lowest) in order of perceived value for diagnosis. Inclusion of one or more accepted additional criterion is sufficient to establish DED as severe.
*Filamentary keratitis is not considered as an additional determinant criterion in Scenario C, as CFS has already established ocular surface damage to be low-level in this case.
†Adequate corneal sensitivity has already been confirmed by OSDI score in Scenarios B and C, and is thus not considered as an additional determinant criterion in these cases.
‡In Scenario C, when CFS is low, the TBUT test is considered as pre-requisite to reconfirm DED diagnosis (in light of primary criteria results).
MGD, meibomian gland disease, DED, dry eye disease, HLA-DR, human leukocyte antigen-DR, MMP, matrix metalloproteinase, TBUT, tear break-up time, sec, second, mOsm, milliosmole, L, litre, mm, millimetre, NA, not applicable, CFS, corneal fluorescein staining, OSDI, Ocular Surface Disease Index.