RESUMEN
PURPOSE: To evaluate the effect of dexamethasone/netilmicin (dexa/net) fixed combination in the treatment of ocular inflammation after sutureless micro-incisional vitreoretinal surgery (MIVS). PATIENTS AND METHODS: This multicenter, open, randomized, active-controlled, parallel-group, clinical trial was run in 6 sites in Italy. Treatment started the day of surgery and continued 4 times daily for 14 days. Patients were 1:1 randomized to dexa/net (eyedrops solution and eye gel) or dexamethasone/tobramycin (dexa/tobra) eyedrops suspension and ointment. Viscous formulations (gel or ointment) were used alone during the early post-operative phase; afterwards, a combination of eye drops during daytime and viscous formulations at bedtime was adopted. The primary efficacy parameter evaluated was bulbar conjunctival hyperemia. Additional efficacy and safety parameters (palpebral conjunctival hyperemia, anterior chamber flare and cells, symptoms of ocular discomfort and ocular tolerance, adverse events and intraocular pressure) were also evaluated. Control visits were performed at day 1, day 4 and day 14 after surgery; the endpoint of the study was set at 14±2 days after surgery. RESULTS: A complete resolution of bulbar conjunctiva hyperaemia at the study end point was reached in 92.9% of patients treated with dexa/net and 75.0% of those treated with dexa/tobra (p=0.02, Fisher's exact test). No differences were observed between treatments for other efficacy parameters. Statistically significant differences in favour of dexa/net (p< 0.0001, ANOVA) were observed for most of subjective tolerance variables examined (blurred vision, foreign body sensation, stickiness, burning) starting day 1 after surgery when only the viscous formulations were used. No increase in intraocular pressure or adverse events was observed during the study. CONCLUSION: The combination dexa/net is safe and effective in the treatment of post-operative inflammation following sutureless MIVS. In particular, the use of eye gel formulation is characterized by a great tolerability.
RESUMEN
PURPOSE: To evaluate the clinical outcome of surgical treatment for macular serous detachment associated with optic disc pit with pars plana vitrectomy (PPV) without laser photocoagulation on the temporal edge. METHODS: Vitrectomy was performed in 8 eyes of 8 patients (mean age 27.25 years; range 12-57 years) with unilateral macular detachment associated with optic disc pit. All patients underwent pars plana vitrectomy (cases 1, 2, 3, and 4, PPV 20 G; cases 5, 6, 7, and 8, PPV 25 G), internal limiting membrane (ILM) peeling, and SF6 20% gas tamponade (case 1 was treated with silicone oil tamponade). Endolaser on the temporal margin of the optic disk was not performed. Every patient was observed for a follow-up period of 59.25 months after surgery. Statistical analysis was carried out using Student t test paired data. p Value <0.05 was considered to be significant. RESULTS: Complete retinal reattachment was achieved in 7 of 8 patients. Case 8 was operated 11 months ago and he still has a small area of subretinal fluid not completely reabsorbed. Mean preoperative best-corrected visual acuity (BCVA) was 20/83 and the mean postoperative BCVA was 20/40. Mean preoperative foveal thickness was 973 µm and mean postoperative foveal thickness was 363.5 µm. Case 7 developed a macular hole after treatment. CONCLUSIONS: Pars plana vitrectomy, ILM peeling, and endotamponade (SF6 20% gas) without endolaser on the temporal edge of optic disc is an effective treatment. This procedure achieved successful anatomical and functional results.