Study population
dry eye disease, allergy, cataract, PD, glaucoma, diabetes
RHEUMATOID ARTHRITIS, PSEUDOEXFOLIATION SYNDROME, ALLERGY, AUTOIMMUNE DISEASES, POLAND, CATARACT, GLAUCOMA, DIABETES
The study included cataract patients who qualified for cataract surgery according to the Polish Standards of Care and Guidelines with absent or mild dry eye disease. The general exclusion criteria were diabetes, allergy, autoimmune diseases, including rheumatoid arthritis, use of systemic treatment that can cause DED, such as antidepressants, antihistamines and spasmolytics, use of systemic or local corticosteroids or nonsteroidal anti-inflammatory drugs. The ocular exclusion criteria at baseline were as follows: OSDI > 15, ocular staining score > 1.0, FBUT < 5 s, Schirmer test < 10 mm after 5 min, use of any other eyedrops other than those included in the study protocol, glaucoma, any previous ocular surgery, pseudoexfoliation syndrome, very advanced cataract (> 4 LOCS III), and endothelial count number below 2000 cells/mmPatients were randomly assigned to one of the treatment groups: the PFD group received preservative-free 0.1% dexamethasone disodium phosphate eyedrops (Dexaprotect, S-Lab, Mirków, Poland) 4 times daily for 2 weeks; the PD group received 0.1% dexamethasone disodium phosphate eyedrops preserved with BAC (Dexamethasone WZF 0,1%, Polfa, Warsaw, Poland) 4 times daily for 2 weeks after surgery. The parallel assignment to one of the study groups followed the random allocation rule, with block size two and four. The random allocation sequence was generated by LS. The investigator (MMW) was blinded to the assigned treatment. The composition of both dexamethasone formulations is presented in Table The composition of the studied dexamethasone 0.1% formulations. Disodium phosphate dodecahydrateNatrium chlorideEdetate disodiumHydrochloric acidSodium hydroxideAqua pro iniectioneDisodium phosphate dodecahydrateSodium dihydrogen phosphate monohydrateNatrium chlorideEdetate disodiumBenzalkonium chloridePolysorbateEthyl alcohol 96%Sodium hydroxidePurified waterOnly one eye per patient was analysed. If the other eye was to be operated on, the surgery was scheduled after completion of all study assessments.