Dexamethasone/Netilmicin Eye Drops and Eye Gel for the Treatment of Ocular Inflammation After Micro-Incisional Vitreoretinal Surgery (original) (raw)
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IP Innovative Publication Pvt. Ltd., 2018
Introduction: Post-operative ocular inflammation is a common occurrence following cataract surgery. Corticosteroids have been used to treat ocular inflammation; however, they carry a risk of side effects, particularly an increase in intra ocular pressure (IOP). Previous studies have proved that difluprednate is more efficacious compared to dexamethasone. Hence this study was undertaken to compare the efficacy of difluprednate ophthalmic emulsion 0.05% and dexamethasone 0.1% in postoperative management after small incision cataract surgery. Materials and Methods: A total 200 patients were selected as per inclusion criteria and equally divided between difluprednate and dexamethasone groups. Dexamethasone 0.1% or difluprednate0.05% was prescribed post operatively following small incision cataract surgery. Patients were examined on post-operative day 1, 7, 15 and 30 for anterior segment by slit-lamp examination and side effects. IOP was measured in both the groups on day 30. Results: In our observation both drugs were efficient in the reduction of anterior chamber cells and flare with difluprednate being more rapid. Corneal edema was reduced equally by both the drugs at all observation periods. There was no clinically significant IOP elevation in both difluprednate and dexamethsone group. Difluprednate was found to be more effective in controlling pain compared to dexamethasone. Conclusion: As per present study both difluprednate ophthalmic emulsion 0.05% eye drops and dexamethasone 0.1% eye drops were equally effective in reducing post cataract surgery inflammation. Hence, difluprednate emulsion 0.05% can be used in postoperative management after cataract surgery; nonetheless, further clinical trials with long follow- up period are required. Keywords: Cataract surgery, Dexamethasone, Difluprednate, Dose uniformity, Ocular inflammation, Opthalmic emulsion.
Clinical ophthalmology (Auckland, N.Z.), 2009
Purpose: To evaluate whether dexamethasone injected intracamerally at the conclusion of surgery can safely and effectively reduce postoperative inflammation and improve surgical outcomes in eyes with and without glaucoma. Methods: Retrospective chart review of 176 consecutive eyes from 146 patients receiving uncomplicated phacoemulsification (PE) (n = 118 total, 82 with glaucoma), glaucoma drainage device (GDD) (n = 35), combined PE/GDD (n = 11) and combined PE/endoscopic cyclophotocoagulation (n = 12). Ninety-one eyes from 76 patients were injected with 0.4 mg dexamethasone intracamerally at the conclusion of surgery. All eyes received standard postoperative prednisolone and ketorolac eyedrops. Outcomes were measured for four to eight weeks by subjective complaints, visual acuity (VA), slit-lamp biomicroscopy, intraocular pressure (IOP) and postoperative complications. Results: Dexamethasone significantly reduced the odds of having an increased anterior chamber (AC) cell score after PE (p = 0.0013). Mean AC cell score ± SD in nonglaucomatous eyes was 1.3 ± 0.8 in control and 0.8 ± 0.7 with dexamethasone; scores in glaucomatous eyes were 1.3 ± 0.7 in control and 0.9 ± 0.8 with dexamethasone. Treated nonglaucomatous eyes had significantly fewer subjective complaints after PE (22.2% vs 64.7% in control; p = 0.0083). Dexamethasone had no significant effects on VA, corneal changes, IOP one day and one month after surgery, or long-term complications. Conclusions: Intracameral dexamethasone given at the end of cataract surgery significantly reduces postoperative AC cells in eyes with and without glaucoma, and improves subjective reports of recovery in nonglaucomatous eyes. There were no statistically significant risks of IOP elevation or other complications in glaucomatous eyes.
Eye, 2007
Purpose The purpose of this study was to evaluate both efficacy and safety of a new ophthalmic steroid-antibiotic fixed combination containing dexamethasone and netilmicin in the postsurgical management of cataract surgery. Methods In total, 223 patients were randomly treated with dexamethasone 1 mg/ml plus netilmicin 3 mg/ml (n ¼ 148), or dexamethasone 1 mg/ml plus tobramycin 3 mg/ ml (n ¼ 75, TOBRADEX s) four times in a day for 771 days starting immediately after surgery. Efficacy (anterior chamber (AC) inflammation, conjunctival hyperaemia, corneal and lid oedema, ocular infection, pain, photophobia and tearing) and safety (burning, stinging, blurred vision, intraocular pressure, and visual acuity) were analysed in the operated eye after 1 and 771 days. A followup visit was performed at day 1472. The extent of AC inflammation, measured by slitlamp according to a standard scoring system, was used as primary efficacy parameter. Results At the primary end point (day 7) both fixed combinations were equally effective in reducing postoperative inflammation. The safety profile of the dexamethasone/netilmicin combination was excellent with no evidence of poor local tolerance or adverse reaction. Conclusions A new fixed combination of dexamethasone and netilmicin was effective and safe in controlling ocular inflammation after cataract surgery.
2006
Background: To compare 0.7% dexamethasone-cyclodextrin aqueous eye drop solution applied once daily with 0.1% dexamethasone sodium phosphate eye drops applied three times a day for the control of postoperative inflammation after cataract surgery. Methods: Twenty cataract patients who underwent phacoemulsification and intraocular lens implantation were randomly divided into two postoperative treatment groups. Postoperative medication in group I included 0.1% dexamethasone sodium phosphate eye drops three times daily and in group II 0.7% dexamethasone-cyclodextrin eye drop solution once daily. Testing of visual acuity, biomicroscopic examination, applanation tonometry and laser flare cell meter (LFCM) examination were carried out before operation and days 1, 3, 7 and 21 after surgery. Results: Preoperative and postoperative visual acuity, aqueous flare and cells in biomicroscopic examination, and the mean intraocular pressure did not show any statistically significant differences between the treatment groups. LFCM examination showed that the mean postoperative photon count values (P=0.032) and the median cell count values on the 1st (P=0.014), 3rd (P=0.031), 7th (P=0.034), and 21st (P=0.0097) postoperative days in group I were more elevated than in group II. Conclusions: 0.7% dexamethasonecyclodextrin eye drops applied once daily is a more effective postoperative anti-inflammatory medication than 0.1% dexamethasone sodium phosphate applied three times a day. In both groups, 3 weeks after the operation the mean visual acuity was normal and intraocular pressure significantly lower than before operation. The use of 0.7% dexamethasone-cyclodextrin eye drops may be useful especially in elderly people who cannot apply themselves the eye drops onto the eye.
Indian Journal of Ophthalmology, 2014
Aim: To compare the effi cacy of postoperative topical nepafenac (0.1%) with prednisolone acetate (1%) as anti-infl ammatory agents in eyes undergoing Transscleral Sutureless Vitrectomy (TSV). Se ings and Design: Prospective, double-blind, randomized, single center clinical study. Materials and Methods: Eighty eyes of 76 subjects, who underwent small gauge vitrectomy, were included in the study. The subjects who fulfi lled the inclusion criteria were randomized to either topical nepafenac only (Group 1) or prednisolone acetate only (Group 2), to be used as postoperative anti-infl ammatory agents. The subjects were reviewed on days 1, 30, and 90. Ocular and adnexal infl ammation was appropriately graded using the standardized classifi cation. Grading of ocular pain was done on the Visual Analog Scale (VAS). Statistical Analysis: The Wilcoxon rank-sum test, using two-sided analysis, was used. Results: During the follow-up, both Group 1 and Group 2 did not have a signifi cant diff erence related to the grade of the anterior chamber infl ammation (P > 0.05) or adnexal infl ammation (P > 0.05). Pain perception was less in the subjects in Group 1 as compared to subjects in Group 2, but was not statistically signifi cant (P > 0.05). Conclusion: Postoperative topical nepafenac was non-inferior to prednisolone acetate in reducing postoperative ocular infl ammation in eyes undergoing TSV.
Clinical Ophthalmology, 2018
Cataract surgery is one of the most commonly performed surgeries worldwide, with nearly 20 million cases annually. Appropriate prophylaxis after cataract surgery can contribute to a safe and quick visual recovery with high patient satisfaction. Despite being the current standard of care, the use of multiple postoperative eye drops can create a significant burden on these patients, contributing to documented and significant non-adherence to the postoperative regimen. Over the past 25 years, there have been a few studies analyzing the use of intracameral dexamethasone (DXM) in controlling inflammation following cataract surgery. This review explores various drug delivery approaches for managing intraocular inflammation after cataract surgery, documenting the strengths and weaknesses of these options and examining the role of intracameral DXM (among these other strategies) in controlling postoperative intraocular inflammation. Intracameral DXM has a particular advantage over topical steroids in possibly decreasing postoperative inflammatory symptoms and objective anterior cell and flare scores. Compared to topical steroids, there may be a slightly less theoretical risk of significant intraocular pressure spikes and systemic absorption. In addition, surveys indicate patients prefer an intraoperative intracameral injection over a self-administered postoperative eye drop regimen. However, there are several adverse effects associated with intracameral DXM delivery that are not seen with the noninvasive topical approach. Although it is unlikely that intracameral DXM will replace topical medications as the standard management for postoperative inflammation, it is seemingly another safe and effective strategy for controlling postoperative inflammation after routine cataract surgery.
Eye, 2020
Background Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance. Methods This International, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the noninferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week goldstandard tobramycin/dexamethasone (one drop QID for all schedules) to prevent and treat ocular inflammation and prevent infection after uncomplicated cataract surgery. Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) around a treatment difference >-10%. The study randomized 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia). The primary endpoint was the proportion of patients without anterior chamber inflammation on day 15 defined as the end of treatment. Endophthalmitis was the key secondary endpoint. This study is registered with EudraCT code: 2018-000286-36. Results After the end of treatment, 95.2% of the patients in the test arm vs. 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: −0.0275/0.0331). No case of endophthalmitis was reported. No statistically significant difference was evident in any of the other secondary endpoints. Both treatments were well tolerated. Conclusions Non-inferiority of the new short pharmacological strategy was proven. One week of levofloxacin/dexamethasone prevents infection, ensures complete control of inflammation in almost all patients and may contain antibiotic resistance. Member of the LEADER-7 Investigators are listed below Acknowledgements.
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv für klinische und experimentelle Ophthalmologie, 2014
In an ongoing prospective multicenter randomised placebo-controlled trial we study the adjuvant use of intravitreal dexamethasone in the treatment of patients with suspected bacterial endophthalmitis after phacoemulsification. In accordance with the study protocol, a mid-inclusion interim analysis of the safety of the study drug was performed. Patients with suspected endophthalmitis after phacoemulsification were asked to participate in this study. A diagnostic vitreous biopsy was taken and the patients received intravitreal injections of 400 micrograms dexamethasone or a placebo, plus 0.2 mg vancomycin and 0.05 mg gentamicin. Injections were repeated after 3 or 4 days. The safety analysis included: the number of eyes with an evisceration; no light perception; or a visual acuity of less than 5/200. Treatment outcome was evaluated in terms of: the percentage of patients with a visual acuity of 20/40 or more and 20/100 or more. The interim analysis included 81 patients with at least 1...