Evaluating the Efficacy and Safety of Aflibercept Biosimilar (P041) Compared with Originator Product in Patients with Neovascular Age-Related Macular Degeneration.

OBJECTIVE: To assess the noninferiority of biosimilar aflibercept (P041, CinnaGen) to the originator aflibercept (AFL, Regeneron) in terms of efficacy, safety, and immunogenicity. DESIGN: This was a phase Ш, 52-week, multicenter, randomized, double-masked, and active control trial involving eyes in a 1:1 ratio. SUBJECTS: Patients with active subfoveal choroidal neovascularization secondary to age-related macular degeneration randomized into the 2 groups of P041 and AFL. METHODS: Patients received an injection of aflibercept every 4 weeks for 3 doses, followed by administration every 8 weeks up to week 48. MAIN OUTCOME MEASURES: The primary outcome was the noninferiority analysis of eyes maintaining vision at week 52. Secondary outcomes included the changes in visual acuity and retinal thickness, safety evaluation, and immunogenicity during the study. RESULTS: In total, 168 eyes of 168 patients were included. At week 52, the proportion of patients maintaining vision was 94.44% in the P041 group compared with 94.52% in the AFL group. The 95% confidence interval (CI) for the difference of maintaining vision from baseline did not exceed the predefined noninferiority margin of 10% (difference, -0.0008; 95% CI, -0.074 to 0.074; P = 0.98). Secondary outcomes indicated similar results in both arms (all P > 0.05). Safety measured outcomes and immunogenicity were similar between the 2 study groups. CONCLUSIONS: Biosimilar aflibercept was noninferior to AFL in eyes with neovascular age-related macular degeneration. Other efficacy and safety findings also indicated the similarity of 2 products. FINANCIAL DISCLOSURES: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Prevalence of refractive errors in population aged 50 years and over: The Gilan eye study.

PURPOSE: To describe the prevalence of refractive error (RE) and its association with other environmental and health factors among population aged ≥50 years who lived in Gilan, Iran in 2014. METHODS: In this population-based cross-sectional study, 3281 individuals aged ≥50 years living in Gilan for at least 6 months were enrolled. The prevalence of different types of REs including myopia (spherical equivalent (SE)≤-0.50D), high myopia (SE ≤ -6.00D), hyperopia (SE≥ + 0.50D), high hyperopia (SE≥ + 3.00D), astigmatism (cylinder < -0.50D) and high astigmatism (cylinder < -2.25D) were determined. Anisometropia was defined as the SE difference of ≥1.00D between the two eyes. Associated factors including age, body mass index (BMI) and education were also studied. RESULTS: 2587 eligible individuals (58% female subjects) with the mean age of 62.6 ± 8.8 years participated (87.6% response rate). The prevalence of myopia, hyperopia and astigmatism was 19.2%, 48.6% and 57.4%, respectively. 3.6% high hyperopia, 0.5% high myopia and 4.5% high astigmatism were identified. The positive simultaneous effects3 of older age (Odds Ratio (OR) = 3.14), nuclear (OR = 1.71) and posterior subcapsular (OR = 1.61) cataracts as well as the negative effects of higher levels of education (OR = 0.28) were obtained on myopia. Higher BMI was found as a risk factor for hyperopia (OR = 1.67), while older patients were less likely to be hyperopic (OR = 0.31). CONCLUSION: Higher incidence of myopia and astigmatism was found in patients aged over 70 years. It was also found that patients at older ages who suffered with cataracts were at a higher risk of myopia, while elderly people with greater BMI were at a higher risk of hyperopia.

Role of Overcorrecting Minus Lens Therapy in Intermittent Exotropia for Prevention of Constant Exotropia in Children Under the Age of 7 Years.

Background: The basis of the overcorrecting minus lens is to induce compliance and consequently prevent constant exotropia. Some previous studies advocated early surgical therapy and others suggested over-minus treatment. Our purpose is to evaluate the success rate of the over-minus lens. Methods: This descriptive cross-sectional study was carried out on 106 patients under the age of 7 years with intermittent exotropia (IXT) who attended Amir-Al-Momenin Hospital at Guilan University of Medical Sciences, Iran. The data was gathered by a form including sex, age, level of cycloplegic refraction, the amount of deviation before and after using the over-minus glasses, visual acuity, the amount of the over-minus glasses, duration of treatment, recovery, and follow-up. The success rate was defined as decreasing exotropia to less than ten prism diopters or exophoria. Results: A total of 106 patients with a mean age of 2.25 ± 0.74 years were enrolled in this study. The mean exotropia before and after treatment was 20.96 ± 8.20 and 12.16 ± 11.04 prism diopters, respectively, and there was a statistically significant difference (P < 0.002). The mean refractive spherical and astigmatic errors (cycloplegic refraction) were +1.34 ± 1.07 and -0.32 ± 0.72 diopters, respectively. At the end of the follow-up, exotropia increased in 5.6% of patients, there was no change in 15% of patients with a mean deviation of 25.0 ± 6.06 prism diopters, and 79.24% of patients were treated successfully. Conclusions: According to the results of this study, treatment of IXT by over-correcting lenses can be a safe procedure and effective in preventing exotropia.

Prevalence of cataract and its contributing factors in Iranian elderly population: the Gilan eye study.

PURPOSE: To report the prevalence and the associated factors leading to cataract among the Iranian population living in Gilan Province, Iran. METHODS: This population-based cross-sectional study was performed from June to November 2014 on 2,975 residents aged ≥ 50 years old living in urban and rural regions of the Gilan Province in Iran. A representative sample of residents in the province was recruited into the study through door-to-door visiting, and baseline data were collected by questionnaire. All participants were referred to the medical center for comprehensive ophthalmic examination, laboratory tests, and blood pressure measurement. RESULTS: Among the population, 2,588 (86.99%) subjects were eligible to be included in this study, categorized either into the cataract or the non-cataract group. The mean age of participants was 62.59 ± 8.92 years, and 57.5% were female. Higher prevalence of cataract was found in individuals of older ages (odds ratio (OR) = 1.13; 95% confidence interval (CI) = 1.10 to 1.16; P < 0.001) and a history of previous ocular surgery (OR = 5.78; 95% CI = 2.28 to 14.63; P < 0.001). At the same time, a lower prevalence of cataract was seen in patients exposed to sunlight for more than 4 h per day (OR = 0.49; 95% CI = 0.32 to 0.73; P = 0.001). CONCLUSION: Cataract affects 50.50% of the study population, especially those over 80. The mildest form of cataract, grade zero, is the most common. Surgery for cataract has good outcomes. The risk of cataract is higher for those older or who have had eye surgeries. People not affected by cataract tend to be exposed to more sunlight.

Closantel retinal toxicity: Recovery from severe vision loss after corticosteroid therapy.

PURPOSE: To present a relatively rare case of retinal toxicity and consequent severe vision loss due to Closantel ingestion. CASE REPORT: A 37-year-old female presented with sudden painless decrease vision in both eyes. She had no previous history of medical disease and denied any trauma. The patient had accidentally ingested Closantel a few days prior to presentation. Closantel is a veterinary anti-helminthic drug used mainly in livestock. Best corrected visual acuity (BCVA) at presentation was 20/200 bilaterally. There was no relative afferent pupillary defect (RAPD) and red saturation test was normal. Macular optical coherence tomography (OCT) revealed disruption in the outer retinal layer and ellipsoid zone in both eyes. A diagnosis of retinal toxicity due to Closantel was made and the patient was started on 1 mg/kg oral prednisolone acetate. On the 45th day after presentation, her BCVA had improved to 20/20 bilaterally. CONCLUSION: Closantel is a potentially toxic drug causing destruction of the neurosensory retina and visual disturbances. We suggest eye-care personnel awareness regarding the risk of Closantel-induced retinal toxicity and prompt treatment with systemic steroids should be considered.

Erratum: Carrier Status for p.Gly61Glu and p.Arg368His CYP1B1 Mutations Causing Primary Congenital Glaucoma in Iran.

[This corrects the article DOI: 10.18502/jovr.v16i4.9747.].

Retinopathy of prematurity: applicability of international and national screening guidelines in the north of Iran.

BACKGROUND: To determine the applicability of current international and national retinopathy of prematurity (ROP) screening guidelines and to identify a suitable community-based screening criterion. METHODS: A retrospective study on premature neonates (≤37 weeks gestation) referred to a tertiary eye hospital ROP clinic in the north of Iran was conducted over a 10-year period. Neonates were classified as no ROP, with ROP and type 1 ROP. Data consisting of birth weight (BW), gestational age (GA) and chief risk factors were evaluated. Various screening criteria and currently established screening guidelines were applied and compared for applicability using a receiver operating characteristic curve. RESULTS: A total of 716 neonates with a mean GA of 31.4 ± 2.8 weeks and BW of 1629 ± 502 grams were screened. The incidence of ROP was 22.9% and type 1 ROP requiring treatment was 0.28%. When applying the national Ministry of Health Guidelines, all neonates with type 1 ROP requiring treatment were identified; These criteria had a specificity of 7% for the diagnosis of type 1 ROP, and a large number of neonates (n=645) who are not at risk for type 1 ROP will be redundantly screened. Guidelines of the American Academy of Pediatrics and the UK would miss 4.5% of patients requiring ROP treatment. According to our data a threshold of GA≤32 weeks and/or BW ≤1600 grams demonstrated a sensitivity of 95.7% and specificity of 33.6% for the diagnosis of any ROP and a sensitivity of 100% and specificity of 26.8% for type 1 ROP requiring treatment. CONCLUSIONS: The ideal ROP screening guideline is one that is very sensitive and identifies patients requiring treatment without delay. To minimize redundant screening while maintaining optimum ROP requiring treatment diagnosis, we proposed a new local evidence-based screening guideline.

Coats'-like Response Associated with Linear Scleroderma.

PURPOSE: To present a case of linear scleroderma known as "en coup de sabre" associated with Coats'- like response. CASE REPORT: A 12-year-old boy presented with subacute painless vision loss in the ipsilateral side of the patient's en coup de sabre lesion. Ocular examination revealed vitreous hemorrhage with severe exudation of the posterior pole and telangiectatic vessels. Fundus fluorescein angiography indicated multiple vascular beadings and fusiform aneurysms with leakage which was consistent with a Coats'-like response. The patient was subsequently treated with intravitreal bevacizumab and targeted retinal photocoagulation. Twelve months' follow-up showed marked resolution of macular exudation with significant visual improvement. CONCLUSION: Physicians should be aware of the possible ophthalmic disorders accompanying en coup de sabre and careful ophthalmologic examinations should be performed in these patients. As presented in the current case, treatment with intravitreal anti-VEGF agents and laser photocoagulation may be a beneficial option for patients with coats'-like response.

Clinical outcomes of viscocanalostomy and phacoviscocanalostomy in primary open angle glaucoma: Two years follow-up.

PURPOSE: To compare the outcomes of phacoviscocanalostomy and viscocanalostomy in patients with primary open angle glaucoma. METHODS: This non randomized, prospective comparative study included 168 eyes of 168 patients with primary open angle glaucoma (POAG). Phacoviscocanalostomy was performed in 94 eyes with POAG and cataract and viscocanalostomy was performed in 74 eyes with POAG. Preoperative and postoperative intraocular pressures (IOP), number of antiglaucoma medication, intraoperative and postoperative complications were recorded throughout the follow-up period. RESULTS: The mean follow-up after surgery was 20.13 ± 7.9 months. Mean IOP decreased significantly 1 month after surgery in both groups (p < 0.001) and remained significantly lower from its preoperative value at all follow-up visits. The postoperative mean IOP at the last follow up in phacoviscocanalostomy and viscocanalostomy was 14.98 ± 4.8 mmHg and 16.84 ± 5.0 mmHg, respectively (p = 0.001). Complete success rate in phacoviscocanalostomy and viscocanalostomy groups was 83.1% and 56.8%, respectively (p = 0.008). Qualified success rate was achieved in 89.4% eyes in the phacoviscocanalostomy group and 83.8% of viscocanalostomy group (p = 0.534). The Best corrected visual acuity (BCVA) in phacoviscocanalostomy group improved significantly post-operatively (p = 0.001). Postoperative antiglaucoma medication in both groups were significantly less than the preoperative values (p = 0.001). CONCLUSIONS: Both Phacoviscocanalostomy and viscocanalostmy are effective procedures in the control of IOP in patients with POAG with and without cataract. Higher complete success rates and BCVA were achieved in phacoviscocanalostomy. Therefore, phacoviscocanalostomy and viscocanalostomy are recommended in eyes with medically uncontrolled primary open-angle glaucoma with and without coexisting cataract.

Unraveling the genetic complexities of combined retinal dystrophy and hearing impairment.

Usher syndrome, the most prevalent cause of combined hereditary vision and hearing impairment, is clinically and genetically heterogeneous. Moreover, several conditions with phenotypes overlapping Usher syndrome have been described. This makes the molecular diagnosis of hereditary deaf-blindness challenging. Here, we performed exome sequencing and analysis on 7 Mexican and 52 Iranian probands with combined retinal degeneration and hearing impairment (without intellectual disability). Clinical assessment involved ophthalmological examination and hearing loss questionnaire. Usher syndrome, most frequently due to biallelic variants in MYO7A (USH1B in 16 probands), USH2A (17 probands), and ADGRV1 (USH2C in 7 probands), was diagnosed in 44 of 59 (75%) unrelated probands. Almost half of the identified variants were novel. Nine of 59 (15%) probands displayed other genetic entities with dual sensory impairment, including Alström syndrome (3 patients), cone-rod dystrophy and hearing loss 1 (2 probands), and Heimler syndrome (1 patient). Unexpected findings included one proband each with Scheie syndrome, coenzyme Q10 deficiency, and pseudoxanthoma elasticum. In four probands, including three Usher cases, dual sensory impairment was either modified/aggravated or caused by variants in distinct genes associated with retinal degeneration and/or hearing loss. The overall diagnostic yield of whole exome analysis in our deaf-blind cohort was 92%. Two (3%) probands were partially solved and only 3 (5%) remained without any molecular diagnosis. In many cases, the molecular diagnosis is important to guide genetic counseling, to support prognostic outcomes and decisions with currently available and evolving treatment modalities.

Carrier Status for p.Gly61Glu and p.Arg368His CYP1B1 Mutations Causing Primary Congenital Glaucoma in Iran.

PURPOSE: To estimate carrier frequencies of CYP1B1 mutations p.Gly61Glu and p.Arg368His, respectively, in Talesh and the east of Guilan province in Iran with a maximum error of 2%. Previously, it was shown that these CYP1B1 mutations may be relatively prevalent in these regions. METHODS: Population-based screenings were performed. DNA was extracted from saliva samples of 1036 individuals from Talesh and 3029 individuals from the east of Guilan. P.Gly61Glu and p.Arg368His screenings were performed, respectively, by RFLP and ARMS-based PCR protocols. For confirmation, the DNA of individuals with mutations was sequenced using the Sanger protocol. RESULTS: Nine individuals from Talesh (0.86%; 95%CI: 0.45-1.64%) carried the p.Gly61Glu mutation, and 73 from the east of Guilan (2.41%; 95%CI: 1.91-3.04%) carried p.Arg368His. There was no significant difference in frequencies between urban and rural regions of the various cities, nor among four cities within the east of Guilan. CONCLUSION: The frequencies of p.Gly61Glu carriers in Talesh and of p.Arg368His carriers in the east of Guilan were within the 95% confidence interval of a previous study based on screenings of fewer individuals. The reliability of the recent estimates is higher, as the confidence interval for p.Gly61Glu decreased from 6.5% to 1.19% and the interval for p.Arg368His decreased from 4% to 1.13%. Based on the new findings, the maximum expected frequency of p.Gly61Glu carriers in Talesh is 1.64%, and of p.Arg368His carriers in the east of Guilan is 3%. The need for performing premarital screenings in the respective cities can be evaluated.

Outcomes of Phaco-viscocanalostomy in Primary Open Angle Glaucoma versus Pseudoexfoliation Glaucoma.

PURPOSE: Viscocanalostomy represents an alternative to standard penetrating glaucoma surgery. The aim of this study is to compare the outcomes of combined phacoemulsification and viscocanalostomy in eyes with primary open-angle glaucoma (POAG) versus eyes with pseudoexfoliation glaucoma (PEXG). METHODS: In this prospective non-randomized comparative study, eyes with cataract and POAG or PEXG were enrolled. Pre- and postoperative data including best corrected visual acuity (BCVA), intraocular pressure (IOP), and the number of antiglaucoma medications administered were recorded at each visit. All patients underwent phacoviscocanalostomy. Complete success was defined as the IOP of 21 mmHg or less without the administration of medication while a qualified success reported the same IOP parameters either with or without the administration of medication. RESULTS: Fifty-four eyes with POAG and fifty-four with PEXG underwent phacoviscocanalostomy. The mean follow-up time was 23.36 ± 8.8 months (range, 6-40 months). The mean postoperative IOP reduced significantly in both groups, although the mean IOP reduction was significantly greater in PEXG eyes (14.7 ± 8.9 vs 10.1 ± 7.7 mmHg) (P = 0.05). At the final follow-up visit, the mean postoperative IOP was 14.1 ± 2.1 and 16.6 ± 3.5 mmHg in the PEXG and POAG eyes, respectively (P = 0.001). A complete success rate of 88.9% and 75.9% was achieved in PEXG and POAG eyes, respectively (P = 0.07). The qualified success rate was 100% in the PEXG and 85.2% in POAG groups (P = 0.03). CONCLUSION: Phacoviscocanalostomy achieved significant IOP reduction and visual improvement in both POAG and PEXG patients. Our results indicated that in terms of IOP reduction, this procedure was more effective in treating PEXG.

A Population-based Study on the Prevalence and Associated Factors of Age-related Macular Degeneration in Northern Iran the Gilan Eye Study.

Purpose: To estimate the prevalence and associated factors of AMD in an Iranian population in 2014.Methods: In this population-based cross-sectional study, a total of 2975 Iranian residents (age: ≥50 years) from the urban and rural areas of Gilan province were included. The prevalence of different grades of AMD was determined using the International Age-Related Maculopathy Epidemiological Study Group grading system.Results: Of 2975 eligible individuals, 2587 (87.0%) subjects participated and 2275 (76.5%) subjects (62.6 ± 8.8 years old) had gradable fundus photographs. Age- and sex-standardized prevalence of early and late AMD based on the 2016 Iran census were 13.2% (95% confidence interval [CI], 10.6-16.2) and 0.7% (95% CI, 0.4-1.3), respectively. In multivariate analysis, each decade increase in age was associated with the adjusted odds of any (adjusted odds ratio [AOR] = 1.31, 95% CI, 1.09-1.56; P = .0031), early (AOR = 1.27, 95% CI, 1.06-1.53; P = .012) and late AMD (AOR = 2.39, 95% CI, 1.08-5.28; P = .031). Hyperopia was identified to be less frequent in late AMD (AOR = 0.20, 95% CI, 0.04-0.80; P = .024). No significant association was found between AMD and sex, smoking, outdoor working, diabetes, hypertension, pseudophakia, hyperlipidemia and myopia.Conclusion: Gilan Eye Study demonstrated the first estimate of age-specific AMD prevalence in Iran being compatible with other WHO regions. With the expected increase in the life expectancy and aging of Iranians, the number of people affected by AMD will be increasing in future. Healthcare policy makers should be advised to provide more efficient eye care services and preventive strategies in this regard.

Rapid Assessment of Avoidable Blindness and Diabetic Retinopathy in Gilan Province, Iran.

PURPOSE: To conduct an assessment of avoidable blindness and diabetic retinopathy (DR) in Gilan, 2014. METHODS: A cross-sectional population-based survey was performed on a representative sample of urban and rural individuals aged ≥50 years of the province. Blindness was defined as presenting visual acuity (PVA) <3/60 in the better eye. Moderate visual impairment (MVI) and severe visual impairment (SVI) were defined as 6/60 ≤ PVA <6/18 and 3/60 ≤ PVA <6/60 in the better eye, respectively. Diabetes mellitus (DM) was determined based on random blood sugar (RBS) levels ≥200 mg/dL or a previous diagnosis. We used the Scottish grading system to grade DR. RESULTS: We invited 2975 individuals from 85 clusters. Age- and sex-adjusted prevalence and 95% confidence interval (CI) of blindness, SVI, MVI, and DM in 2587 participants (response rate: 86.9%) were 1.5% (95% CI: 1.1-2.0), 1.5% (95% CI: 0.9-2.0), 11.3% (95% CI: 9.9-12.7) and 21.4% (95% CI: 19.2-23.7), respectively. The leading causes of blindness were cataract (47.1%), age-related macular degeneration (14.7%) and DR (8.8%). Cataract surgery (CS) coverage was 69.3%. The main challenges for CS were cost and unawareness. The outcome of CS was good in 66.9% of operated eyes. Any DR and/or maculopathy were observed in 25.3% (95% CI: 21.0-29.5) of subjects including 12.6% (95% CI: 9.7-15.6) sight-threatening DR. In previously known DM cases, 215 (41.7%) had never undergone an eye examination for DR. CONCLUSION: The proportion of avoidable blindness and DR is considerable in Gilan Province.

Comparison of four surgical techniques for management of pseudophakic and aphakic retinal detachment: a multicenter clinical trial.

PURPOSE: To compare the visual and anatomical outcomes of four surgical techniques to manage pseudophakic and aphakic retinal detachment (PARD). METHODS: In a multicenter randomized clinical trial, 211 eyes of 211 patients with PARD and proliferative vitreoretinopathy (PVR) grade B or less were randomly assigned to one of the four treatment groups: (1) scleral buckling (SB), 50 eyes, (2) vitrectomy without band, 51 eyes, (3) vitrectomy with encircling band (EB), 58 eyes, and (4) triamcinolone acetonide (TA) assisted vitrectomy, 52 eyes. Patients were followed for 12 months after the surgery. The best-corrected visual acuity (BCVA) and retinal reattachment rate at each follow-up time point were considered as the primary outcome measures. PVR, macular pucker, and cystoid macular edema were considered as the secondary outcomes. RESULTS: Visual improvement was achieved in all treatment groups relative to the baseline at all time points (all Ps < 0.001). There were no statistically significant differences among the groups with regard to BCVA changes. However, there was a significant difference in the slope of visual improvement curve: the SB group had a more rapid visual improvement compared to the vitrectomy with buckle group at month 12 (P = 0.032). The retinal reattachment rates at month 12 were 75, 64.7, 68.5, and 66.7 % in SB, vitrectomy without buckle, vitrectomy with EB, and TA-assisted vitrectomy groups respectively (P > 0.99). There were no statistically significant differences among the groups in terms of adverse events. CONCLUSIONS: SB, TA-assisted vitrectomy, and vitrectomy with and without buckle had comparable outcomes in the management of PARD.

Incidence and Risk Factors for Retinopathy of Prematurity in North of Iran.

PURPOSE: To report the incidence and risk factors for retinopathy of prematurity (ROP) among preterm infants referred to Amiralmomenin Eye Hospital, Rasht, Iran. METHODS: This cross-sectional retrospective study included all preterm infants with birth weight ≤2500 g and/or gestational age ≤36 weeks who had been referred to our facility for ROP screening over a five year period from September 2005 to September 2010. Possible risk factors and findings related to eye examinations were extracted and analyzed. RESULTS: Among 310 infants, ROP was diagnosed in 64 (20.6%) of referred preterm infants (95% CI: 17.7%-23.5%); these included stage I in 48%, stage 2 in 29%, and stage 3 or higher disease in 23% of subjects. Mean gestational age (GA) and birth weight (BW) in the ROP-affected infants was 30.18 ± 2.28 weeks and 1,422.8 ± 420.8 g, respectively. Low BW, low GA, oxygen therapy, phototherapy, blood transfusion and apnea were risk factors for ROP. After logistic regression analysis, only low GA and low BW were independently associated with the condition. CONCLUSION: ROP is a relatively common finding in preterm infants of Guilan Province in the North of Iran. Low BW and low GA were significant risk factors for the disease.

Reproducibility of optical coherence tomography retinal nerve fiber layer thickness measurements before and after pupil dilation.

PURPOSE: To evaluate the intra- and interobserver reproducibility of peripapillary retinal nerve fiber layer (RNFL) thickness measurements before and after pupil dilation using spectral-domain optical coherence tomography (SD-OCT). METHODS: In this observational case series, 44 eyes of 44 healthy subjects were scanned by two trained operators on the same day, using Cirrus SD-OCT (Carl Zeiss Meditec, Dublin, CA, USA). Three scans were obtained before and after pupil dilation by each operator. Mean ± standard deviation (SD) and coefficient of variation (CV) were used for description of results and variation of measurements respectively. Intraclass correlation coefficients (ICC) and Bland-Altman plots were used to evaluate validation and limits of agreement. RESULTS: Overall, 23 female and 21 male subjects with mean age of 36.9±8.8 (range, 20 to 50) years were enrolled. Mean RNFL thickness before pupil dilation was 92.6±7.2 (CV, 7.8%) and 92.4±6.8 (CV, 7.4%) µm by operator one and two, respectively. After pupil dilation, mean RNFL thickness was 92.7±7.9 (CV, 8.5%) and 92.0±7.5 (CV=8.2%) µm by observer one and two, respectively. ICCs ranged from 0.900 to 0.996. Mean absolute error of the two operators was less than 4.1µm. There were no significant differences in quadrant thicknesses before and after dilation. Interestingly, mean signal strength was not significantly affected by pupil dilation. CONCLUSION: In normal subjects with clear media, peripapillary RNFL thickness measurements using Cirrus SD-OCT have high inter- and intraobserver reproducibility before and after pupil dilation. Pupil dilation may not be necessary in all subjects to obtain reproducible RNFL thickness measurements.

Slow versus Rapid Fluorescein Injection in Angiographic Studies for Retinal Vascular Disorders.

PURPOSE: To compare the incidence of adverse reactions following rapid versus slow fluorescein injection for fundus angiography. METHODS: This randomized controlled trial was performed on 500 patients with retinal vascular disorders. Subjects with central serous retinopathy, age-related macular degeneration and retinal pigment epithelial changes were excluded. Pregnancy, asthma, allergic diseases and previous history of reactions to fluorescein were other exclusion criteria. Patients were randomly divided into two equal groups who received slow infusion of dye (over 15-25 seconds) versus the usual rapid injection (in 5-8 seconds), and were compared for adverse effects. RESULTS: Overall, 47 (9.4%) patients including 34 (13.6%) subjects in the rapid group and 13 (5.2%) cases in the slow group developed adverse reactions (P=0.001, relative risk=2.6). All adverse reactions were categorized as mild; no instance of moderate or severe reactions was observed. There was a lower incidence of nausea and vomiting with slow infusion of fluorescein (P=0.02), however no statistically significant difference was observed in the frequency of vertigo and vasovagal reactions between the study groups. CONCLUSION: Slow fluorescein injection during fundus angiography, instead of the usual rapid application, can be an effective way to reduce the incidence of nausea and vomiting in patients whose first phase of angiography is of little diagnostic importance.

Prospective randomized trial of trimethoprim/sulfamethoxazole versus pyrimethamine and sulfadiazine in the treatment of ocular toxoplasmosis.

OBJECTIVE: To compare the efficacy of the classic treatment of ocular toxoplasmosis (pyrimethamine, sulfadiazine, and prednisolone) with a regimen consisting of trimethoprim/sulfamethoxazole (co-trimoxazole) plus prednisolone. DESIGN: Prospective randomized single-blind clinical trial. PARTICIPANTS: Fifty-nine patients with active ocular toxoplasmosis were randomly assigned to 2 treatment groups: 29 were treated with pyrimethamine/sulfadiazine, and 30 patients received trimethoprim/sulfamethoxazole. INTERVENTION: Treatment consisted of 6 weeks' treatment with antibiotics plus steroids. Antitoxoplasmosis antibodies (immunoglobulin M [IgM] and IgG) were measured using an enzyme-linked immunosorbent assay. MAIN OUTCOME MEASURES: Changes in retinochoroidal lesion size after 6 weeks' treatment, visual acuity (VA) before and after intervention, adverse drug reactions during follow-up, and rate of recurrence. RESULTS: Active toxoplasmosis retinochoroiditis resolved in all patients over 6 weeks' treatment, with no significant difference in mean reduction of retinochoroidal lesion size between the 2 treatment groups (61% reduction in the classic treatment group and 59% in the trimethoprim/sulfamethoxazole group, P = 0.75). Similarly, no significant difference was found in VA after treatment between the 2 groups (mean VAs after treatment were 0.12 logarithm of the minimum angle of resolution [logMAR] [20/25] in the classic treatment group and 0.09 logMAR [20/25] in the trimethoprim/sulfamethoxazole group, P = 0.56). Adverse effects were similar in both groups, with one patient in each suffering from any significant drug side effects. The overall recurrence rate after 24 months' follow-up was 10.16%, with no significant difference between the treatment groups (P = 0.64). CONCLUSIONS: Drug efficacies in terms of reduction in retinal lesion size and improvement in VA were similar in a regimen of trimethoprim/sulfamethoxazole and the classic treatment of ocular toxoplasmosis with pyrimethamine and sulfadiazine. Therapy with trimethoprim/sulfamethoxazole seems to be an acceptable alternative for the treatment of ocular toxoplasmosis.