A comparison of two ophthalmic steroid-antibiotic combinations after cataract surgery.
We performed this prospective, randomised, investigator-masked, parallel-group study to compare Fluorometholone-Gentamicin eye drops with Maxitrol (dexamethasone, neomycin, polymyxin B) eye drops in the reduction of ocular bacterial flora and control of ocular inflammation after cataract surgery. One hundred and twelve (FML-Genta 54, Maxitrol 58) patients of both sexes undergoing cataract and posterior chamber lens implant surgery for visually disabling cataract were enrolled in the study and examined pre-operatively and post-operatively on days 1, 6-8 and 24-34. The baseline parameters were similar in the two study groups. The conjunctival bacterial colony count on day 6-8 post-operatively was significantly less on FML-Genta compared with Maxitrol (p = 0.033). There was no statistically significant difference between the two treatments in the degree of intra-ocular inflammation as assessed by flare and cells in the anterior chamber. Both treatments were judged to be equal in the global assessment of the success of therapy and local tolerance by the study patients and doctors. Fluorometholone-gentamicin eye drops were more effective than Maxitrol eye drops in the reduction of ocular bacterial flora while being as well-tolerated and as effective as Maxitrol in the control of ocular inflammation after cataract surgery.
van Endt
J J
JJ
Department of Ophthalmology, St. Franciscus Ziekenhuis, Roosendaal, The Netherlands.
Veraart
H G
HG
Kramer
R
R
Janssen
A G
AG
Sunder Raj
P
P
D000287:Administration, Topical; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects / Q000254:growth & development; D002387:Cataract Extraction / Q000009:adverse effects*; D015169:Colony Count, Microbial; D003228:Conjunctiva / Q000382:microbiology; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D009877:Endophthalmitis / Q000209:etiology / Q000517:prevention & control; D015817:Eye Infections / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005469:Fluorometholone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005477:Fluprednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005839:Gentamicins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005938:Glucocorticoids; D006801:Humans; D007910:Lenses, Intraocular; D008297:Male; D009355:Neomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009883:Ophthalmic Solutions; D011112:Polymyxin B / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies
D000900:Anti-Bacterial Agents; D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; D005839:Gentamicins; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; C049064:Maxitrol; D005477:Fluprednisolone; D009355:Neomycin; D011112:Polymyxin B; D005469:Fluorometholone