Masoud Soheilian

Randomized Trial of Intravitreal Bevacizumab Alone or Combined with Triamcinolone versus Macular Photocoagulation in Diabetic Macular Edema

PURPOSE To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment of diabetic macular edema (DME). DESIGN Randomized 3-arm clinical trial. PARTICIPANTS A total of 150 eyes of 129 patients with clinically significant DME and no previous treatment. METHODS The eyes were randomly assigned to 1 of the 3 study arms: the IVB group, patients who received 1.25 mg IVB (50 eyes); the IVB/IVT group, patients who received 1.25 mg of IVB and 2 mg of IVT (50 eyes); and the MPC group, patients who underwent focal or modified grid laser (50 eyes). Retreatment was performed at 12-week intervals whenever indicated. MAIN OUTCOME MEASURES Change in best-corrected visual acuity (VA) at week 24. RESULTS VA changes among the groups were statistically significant at 6 (P<0.001) and 24 (P = 0.012) weeks. The significant treatment effect was demonstrated in the IVB group at all follow-up visits and in the IVB/IVT group at 6 and 12 weeks. VA changes +/- standard deviation at 36 weeks were -0.28+/-0.25, -0.04+/-0.33, and +0.01+/-0.27 logarithm of minimum angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively (P = 0.053). Significant central macular thickness (CMT) reduction was observed in all groups only up to 6 weeks; however, CMT changes were not significant among the groups in all visits. Overall, retreatment was required for 27 eyes up to 36 weeks (14 in the IVB group, 10 in the IVB/IVT group, and 3 in the MPC group). In the IVB group, in which a greater VA improvement was observed, only 1 injection was required in 72% of the cases. VA improvement >2 Snellen lines at 36 weeks was detected in 37%, 25%, and 14.8% of patients in the IVB, IVB/IVT, and MPC groups, respectively. CONCLUSIONS Intravitreal bevacizumab injection in patients with DME yielded a better visual outcome at 24 weeks compared with macular photocoagulation. A change in CMT beyond the 6-week time point that corresponded to the vision change was not detected. No adjunctive effect of IVT was demonstrated. FINANCIAL DISCLOSURE(S) The author(s) have no proprietary or commercial interest in any materials discussed in this article.

INTRAVITREAL BEVACIZUMAB (AVASTIN) INJECTION ALONE OR COMBINED WITH TRIAMCINOLONE VERSUS MACULAR PHOTOCOAGULATION AS PRIMARY TREATMENT OF DIABETIC MACULAR EDEMA

Purpose: To report the efficacy of a single intravitreal bevacizumab injection alone or in combination with intravitreal triamcinolone acetonide versus macular laser photocoagulation (MPC) as primary treatment of diabetic macular edema (DME). Methods: In this randomized, three-arm clinical trial, 103 eyes of 97 patients with clinically significant DME and no previous treatment were enrolled. The eyes were randomly assigned to one of three study arms: the intravitreal bevacizumab (IVB) group, patients who received 1.25 mg of intravitreal bevacizumab (37 eyes); the IVB/IVT group, patients who received 1.25 mg of intravitreal bevacizumab and 2 mg of intravitreal triamcinolone (33 eyes); and the MPC group, patients who underwent focal or modified grid laser (33 eyes). Primary outcome measure was change in visual acuity. Results: Visual acuity changes ± SD at 12 weeks were −0.22 ± 0.23, −0.13 ± 0.31, and + 0.08 ± 0.31 logarithm of the minimal angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively. The marginal regression model based on generalized estimating equation analysis demonstrated that the visual acuity changes in the groups were statistically significant at both 6 weeks (P < 0.0001) and 12 weeks (P = 0.024). The significant treatment effect was demonstrated at both 6 weeks and 12 weeks in the IVB group and only at 6 weeks in the IVB/IVT group. Significant central macular thickness (CMT) reduction was observed in eyes in the IVB and IVB/IVT groups only up to 6 weeks; however, CMT changes were not significant in the groups. Conclusion: Up to 12 weeks, intravitreal bevacizumab treatment of patients with DME yielded better visual outcome than laser photocoagulation, although it was not associated with a significant decrease in CMT. No further beneficial effect of intravitreal triamcinolone could be demonstrated. Further clinical trials with longer follow-up are required to evaluate the long-term visual outcomes and complication profiles after primary treatment with such medications.

Randomized Trial of Intravitreal Clindamycin and Dexamethasone versus Pyrimethamine, Sulfadiazine, and Prednisolone in Treatment of Ocular Toxoplasmosis

PURPOSE To compare the efficacy of intravitreal injection of clindamycin and dexamethasone with classic treatment for ocular toxoplasmosis. DESIGN Prospective, randomized single-masked clinical trial. PARTICIPANTS A total of 68 patients with active ocular toxoplasmosis were assigned randomly to 2 treatment groups: 34 in the intravitreal clindamycin plus dexamethasone (IVCD) group and 34 in the classic treatment (CT) group. INTERVENTION The IVCD group received 1 to 3 injection(s) of 1 mg intravitreal clindamycin and 400 μg dexamethasone, and the CT group received 6 weeks of treatment with pyrimethamine and sulfadiazine plus prednisolone. Antitoxoplasmosis antibodies (immunoglobulin [Ig] M and IgG) were measured using an enzyme-linked immunosorbent assay. MAIN OUTCOME MEASURES Changes in retinochoroidal lesion size, measured by a computer program written in the MATLAB environment, 6 weeks after initiation of treatment. Visual acuity (VA) changes, vitreous inflammatory response, adverse drug reactions, and rate of recurrence were secondary outcome measures. RESULTS The mean number of injections in the IVCD group was 1.6. The lesion size reduction was statistically significant after treatment in both IVCD and CT groups (P < 0.001 and P = 0.009, respectively). However, the difference in mean percentage of reduction at 6 weeks was not significant: 57.0 ± 27.8% in the IVCD group versus 58.4 ± 29.3% in the CT group (P = 0.569). In relation to the baseline, VA increased by 0.44 ± 0.24 and 0.29 ± 0.19 logarithm of the minimum angle of resolution units in the IVCD and CT groups, respectively (P < 0.001); however, the difference of VA improvement between the groups was not significant. The interaction effect of IgM and treatment group on lesion size reduction was significant (P = 0.002); this indicated that IgM-positive cases responded better to CT and IgM-negative cases responded better to IVCD treatment. Vitreous inflammation reduction was insignificant between the groups. Within 2 years, 4 eyes (2 in each group) had 1 episode of recurrence. Adverse drug reactions occurred in 2 patients in the CT group. No major injection-related complication was encountered in the IVCD group. CONCLUSIONS Intravitreal injection of clindamycin and dexamethasone may be an acceptable alternative to the classic treatment in ocular toxoplasmosis. It may offer the patient more convenience, a safer systemic side effect profile, greater availability, and fewer follow-up visits and hematologic evaluations.

Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema.

Purpose The purpose of this study was to report the 24-month findings of a randomized clinical trial comparing intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment for diabetic macular edema. Methods The eyes were randomly assigned to 1 of the 3 study arms: the IVB group, patients who received 1.25 mg IVB; the IVB/IVT group, patients who received 1.25 mg of IVB and 2 mg of IVT; and the MPC group, patients who underwent focal or modified grid laser. Of 150 eyes (50 in each group) in the primary trial, 123, 119, and 113 eyes completed follow-ups at 12, 18, and 24 months, respectively. A total of 39 (78%), 36 (72%), and 38 (76%) eyes in the IVB, IVB/IVT, and MPC groups remained in the study within 24 months, respectively. Retreatment was performed at 3-month intervals whenever indicated. Data from a 24-month follow-up are presented. Changes in best-corrected visual acuity and central macular thickness up to 24 months were the main outcome measures in this study. Results Retreatment was required in 37 (94.9%), 27 (75.0%), and 31 (81.6%) eyes, respectively, in the IVB, IVB/IVT, and MPC groups up to 24 months. The significant superiority of visual acuity improvement in the IVB group, which had been noted at Month 6, did not sustain thereafter up to 24 months, and the difference among the groups was not significant at all visits. However, the mean visual acuity improvement was greater in the IVB group than the other groups and in the IVB/IVT group compared with the MPC group. The reduction of central macular thickness was more in the IVB group in relation to the other two treatment groups; however, the difference among the groups was not statistically significant at any of the follow-up visits. Conclusion In terms of vision improvement, the significant superiority of the IVB over the combined IVB/IVT and MPC treatment that had been observed at Month 6 did not sustain up to 24 months. This means that although IVB treatment may be a better choice than two other options in short term, the magnitude of this beneficial effect diminishes over time.

Pilot study of intravitreal injection of diclofenac for treatment of macular edema of various etiologies.

Purpose: The purpose of this study was to evaluate the effect of a single dose of intravitreal diclofenac, a potent nonsteroidal antiinflammatory drug, on visual acuity and central macular thickness in patients with macular edema of various etiologies. Methods: In this prospective noncomparative case series, 10 eyes of 10 patients with clinically significant diabetic macular edema (n = 5), neovascular age-related macular degeneration (n = 2), pseudophakic cystoid macular edema (n = 1), macular edema secondary to old branch retinal vein occlusion (n = 1), and cystoid macular edema secondary to chronic intermediate uveitis (n = 1) received 500 &mgr;g/0.1 mL of intravitreal diclofenac. The primary outcome measure was change in visual acuity. Results: After 2 weeks, visual acuity improved in 3 (30%) eyes (P = 0.78), did not change in 3 (30%) eyes, and decreased in 3 (30%) eyes. After 4 weeks, improvement of best-corrected visual acuity occurred in 5 (50%) eyes (P = 0.07), but in 3 eyes (30%), best-corrected visual acuity did not change, and in 1 eye (10%), visual acuity decreased. After 8 weeks, visual acuity improved in 7 (70%) eyes (P = 0.019), got worse in 1 eye (10%), and did not change in 2 eyes (20%). Central macular thickness did not decrease significantly at 8 weeks. On the basis of electroretinography, no significant changes in the amplitude of a-wave or b-wave in relation to baseline were noticed in any eye. Conclusion: Up to 8 weeks, intravitreal diclofenac treatment of eyes with macular edema of various etiologies yielded prominent improvement in visual acuity but was not associated with a significant decrease in central macular thickness. No toxic effect of intravitreal diclofenac was observed.

Intermediate Uveitis and Retinal Vasculitis as Manifestations of Cat Scratch Disease

PURPOSE To study the ocular manifestations of systemic Rochalimaea infection. METHODS We examined a healthy 21-year old woman who had floaters in both eyes. A bilateral mild vitreitis and multiple foci of retinal vasculitis were found; during the ensuing two weeks, exudates appeared over the inferior pars plana. The patient owned five kittens but had no history of cat bites or scratches. Serum levels of antibodies to Rochalimaea were elevated. RESULT The retinal vasculitis and vitreitis resolved after three weeks of therapy with ciprofloxacin hydrochloride without concomitant anti-inflammatory therapy. CONCLUSION Rochalimaea infection should be considered in the differential diagnosis of intermediate uveitis and retinal vasculitis.

PRIMARY CAPSULECTOMY, ANTERIOR VITRECTOMY, LENSECTOMY, AND POSTERIOR CHAMBER LENS IMPLANTATION IN CHILDREN: LIMBAL VERSUS PARS PLANA

PURPOSE To compare the results of a limbal versus a pars plana approach for primary posterior capsulectomy and anterior vitrectomy in the management of childhood cataract. SETTING Department of Ophthalmology, Labbafinejad Medical Center, Tehran, Iran. METHODS A randomized, controlled, double-masked clinical trial of 45 eyes was conducted. After being matched, 38 eyes were included in the study and were divided into 2 equal groups for data analysis. All eyes had lensectomy and posterior chamber intraocular lens (PC IOL) implantation. Primary posterior capsulectomy and anterior vitrectomy were performed through the limbus in half of the eyes and the pars plana in the other half. Main outcome measures included visual acuity, estimated red reflex, postsurgical inflammatory reaction, corneal clarity, posterior synechias, iris capture, IOL position, capsulectomy size, glaucoma, cystoid macular edema, retinal tear, and postoperative refraction. RESULTS No statistically significant differences were found between the 2 approaches in the outcome measures. CONCLUSION The anatomic and visual results were encouraging when posterior capsulectomy and anterior vitrectomy, using a limbal or pars plana approach, were combined with lensectomy and PC IOL implantation in children. The application of these techniques depends on surgeon experience and skill.

Single-session photodynamic therapy combined with intravitreal bevacizumab and triamcinolone for neovascular age-related macular degeneration

BackgroundTo evaluate the efficacy of triple therapy consisting of single-session photodynamic therapy (PDT), intravitreal bevacizumab (IVB) and intravitreal triamcinolone (IVT) as initial pulse therapy followed by repeat intravitreal bevacizumab injections for maintenance treatment in neovascular age-related macular degeneration (AMD).MethodsIn a prospective interventional case series, patients with subfoveal choroidal neovascularization (CNV) secondary to AMD underwent pulse therapy with single-session PDT according to the standard protocol followed by 1.25 mg IVB and 2 mg IVT 48 hours later. Best corrected visual acuity (BCVA) was assessed and optical coherence tomography (OCT) and fluorescein angiography (FA) were performed prior to treatment. BCVA and OCT measurements were repeated at 6 week intervals and FA was obtained after 12 weeks and when necessary thereafter. Repeat injections of IVB were performed based on fluorescein angiographic evidence of CNV leakage.ResultsThis series included 17 eyes of 17 patients with mean age of 67.6 ± 7.2 years. Mean follow up duration was 50.4 ± 15.5 weeks. Mean BCVA prior to treatment was 0.74 ± 0.33 logMAR which improved to 0.52 ± 0.36 logMAR after 12 weeks (P = 0.012) and 0.41 ± 0.38 logMAR after 24 weeks (P = 0.001). Mean pretreatment central macular thickness (CMT) was 395 ± 181μ which was significantly reduced to 217 ± 69μ (P = 0.005), 231 ± 79μ (P = 0.028) and 221 ± 87μ (P = 0.05) six, twelve and twenty-four weeks after initial treatment respectively. Visual acuity improvement and CMT reduction was maintained during the follow-up period. IVB injections were repeated once, twice and three times in 10, 7 and 2 eyes at a mean interval of 20.2 ± 10.1, 19 ± 13.7 and 15 ± 1.4 weeks after initial therapy, respectively.ConclusionInitial pulse triple therapy consisting of single-session PDT combined with IVB and IVT improves vision and reduces CMT in neovascular AMD. Repeat IVB injections maintain the visual gain from the initial combination therapy.

TRANSVITREAL OPTIC NEUROTOMY FOR NONARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY

Purpose To evaluate the role of transvitreal optic neurotomy in the treatment of nonarteritic anterior ischemic optic neuropathy, a scleral outlet compartment syndrome, in which neurovascular compression at the prelaminar and laminar regions of the optic nerve head may play a major role. Methods Seven eyes of seven selected patients with severe vision loss (<20/800) from nonarteritic anterior ischemic optic neuropathy underwent transvitreal nasal radial optic neurotomy. The study was not masked and not randomized. Visual acuity and visual fields, when possible, were measured, and fluorescein angiography was performed preoperatively and postoperatively. Results Four male and three female patients had a mean age of 52.4 years; five had bilateral disease. The mean follow-up was 13 ± 7 weeks. Mean preoperative visual acuity was 20/2400; mean postoperative visual acuity was 20/250, with an average of 10 lines of improvement. Six of seven patients showed visual improvement. One patient had peripapillary choroidal neovascularization. In two patients with sufficient visual acuity, preoperative visual fields could be obtained; these patients showed significant improvement in postoperative perimetry. Five patients had some loss of vision, which made it impossible to obtain preoperative visual fields. Conclusion Relaxation of the scleral ring of the prelaminar and laminar regions of the optic nerve head reduces constriction and may prevent necrosis of salvageable but underperfused nerve fibers. Despite improvement of visual acuity in our patients, transvitreal optic neurotomy should be considered experimental, requiring a randomized clinical trial.

Factors influencing anatomic and visual results in primary scleral buckling

PURPOSE To identify the factors influencing anatomical and visual results in cases of rhegmatogenous retinal detachment undergoing primary scleral buckling. METHODS A retrospective study of 233 eyes of 226 patients was done. The data were evaluated by univariate analysis and stepwise logistic regression analysis. RESULTS Retinal reattachment was achieved with primary scleral buckling in 197 eyes (84.5%). The extent of retinal detachment, preoperative proliferative vitreoretinopathy (PVR), preoperative visual acuity and relative afferent pupillary defects were identified as influencing anatomical results, by univariate analysis. The predictive roles of extent of retinal detachment (P<0.0001) and preoperative PVR (P=0.0085) were shown to be significant by step-wise logistic regression. As well as the above factors, the patients age, the duration of symptoms and the status of the macula were predictors of visual results, by univariate analysis. Stepwise logistic regression analysis confirmed the predictive roles of preoperative visual acuity (P<0.0001) and the extent of retinal detachment (P=0.0089). CONCLUSIONS Cases with a larger extent of retinal detachment, more advanced preoperative PVR and poorer preoperative visual acuity have less favorable anatomical and functional results.