Postoperative treatment with topical diclofenac versus topical dexamethasone after combined phacotrabeculectomy with mitomycin C.
OBJECTIVE
The objective of the study was to compare the efficacy and safety of topical dexamethasone sodium phosphate 0.1% (Sterodex) to diclofenac sodium 0.1% (Voltaren Ophthalmic) after combined phacotrabeculectomy with mitomycin C.


METHODS
This prospective, randomized, double-masked clinical trial includes 42 patients with glaucoma and cataract who underwent a combined phacotrabeculectomy. Patients were randomly assigned to postoperative treatment with topical diclofenac sodium 0.1% or topical dexamethasone phosphate 0.1%. Follow-up duration was 12 months and all examinations were masked. The main outcome measures were intraocular pressure (IOP), number of glaucoma medications, and bleb morphology.


RESULTS
Baseline characteristics of the diclofenac (n=21) and dexamethasone (n=21) patients were similar. Phacotrabeculectomy with both postoperative treatments was effective in reducing IOP, lowering the number of glaucoma medications and improving visual acuity at all follow-up points. The average number of medications taken by the dexamethasone group was significantly greater than the diclofenac group at 8 months (1.2 ± 1.4 and 0.3 ± 0.6, respectively, P=0.03). The mean bleb height of the diclofenac group was significantly higher than the dexamethasone group at 3 weeks (P=0.05), and the mean bleb width was significantly wider at 8 months (P=0.04). No significant group differences in IOP were found at any of the follow-up visits, although there was a clinical trend toward lower IOP values in the diclofenac group. Sixteen patients (76%) in the diclofenac group and 17 patients in the dexamethasone group (81%) completed 1 year of follow-up.


CONCLUSIONS
In this preliminary study, diclofenac sodium is at least as good as topical dexamethasone phosphate for glaucoma patients undergoing two-site combined phacotrabeculectomy with mitomycin C.
Goldschleger Eye Institute, Sheba Medical Center, Tel-Hashomer, Israel. hani_levkovitch-verbin@hks10.harvard.edu
Hani
H
Levkovitch-Verbin
Gabriel
G
Katz
Maia
M
Kalev-Landoi
Modi
M
Goldenfeld
D000287:Administration, Topical; D000368:Aged; D000477:Alkylating Agents / Q000008:administration & dosage; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002386:Cataract / Q000150:complications; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005901:Glaucoma / Q000150:complications; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D016685:Mitomycin / Q000008:administration & dosage; D009883:Ophthalmic Solutions; D018918:Phacoemulsification; D011182:Postoperative Care; D011446:Prospective Studies; D014130:Trabeculectomy; D014792:Visual Acuity / Q000502:physiology
D000477:Alkylating Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005938:Glucocorticoids; D009883:Ophthalmic Solutions; D004008:Diclofenac; D016685:Mitomycin; D003907:Dexamethasone