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.

The association between the severity of diabetic retinopathy and cognitive impairment: a cross-sectional study.

PURPOSE: To assess the correlation among cognitive impairment (CI) and the degree of diabetic retinopathy (DR). METHODS: The current analytic cross-sectional study has been carried out on two hundred ten individuals having diabetes mellitus type 2. Individuals were split into 7 groups in order of severity of DR in the worse eye with 30 cases in each group. Cognition function has been determined utilizing mini-mental state examination (MMSE) and montreal cognitive assessment (MoCA) tests. RESULTS: Comparing the severity of CI using both MMSE and MoCA tests, statistically substantial differences have been discovered among individuals without DR, those having non-proliferative diabetic retinopathy (NPDR), and proliferative diabetic retinopathy (PDR) (p < 0.001). The greatest percentage of severe and moderate CI was seen in the PDR group. Regarding the severity of CI, there has been a statistically substantial difference among NPDR and PDR groups, as well as among no-DR and PDR groups (p < 0.001). Moreover, the severity of CI in the MMSE and MoCA tests had a negative connection with the grades of DR (r = - 0.522, P < 0.001 and r = - 0.540, P < 0.001, respectively). CONCLUSION: We discovered a negative connection between the grades of DR and the severity of CI that persisted as a significant finding, showing that patients with more severe DR tended to have higher levels of CI. These results might offer retinal examination or retinal photography as a promising strategy for mass screening of CI in diabetic patients, especially if it is combined with artificial intelligence and telemedicine.

The Association Between Choroidal Thickness and Meniere's Disease: A Cross-Sectional Study.

OBJECTIVE: To evaluate and compare choroidal thickness (CT) between patients with Meniere's disease (MD) and a control group. METHODS: This case-control analytical study was conducted on 37 subjects with MD and 37 healthy subjects. Subfoveal CT (SCT), large choroidal vessel (LCV) layer thickness, and mean subfoveal LCV thickness/mean SCT ratio were measured using enhanced-depth imaging optical coherence tomography (EDI-OCT) in the eyes on the MD side (ipsilateral), the contralateral eyes, and the control group. RESULTS: A statistically significant difference was observed in the mean SCT values between the ipsilateral and control groups after adjustment for age, sex, and migraine (p = 0.04). Moreover, there was a statistically significant difference between the mean subfoveal LCV thickness values and the mean subfoveal LCV thickness/mean SCT ratio between the ipsilateral and control groups (p = 0.006, and p < 0.001, respectively). Patients with a duration of disease over three years had a greater mean subfoveal LCV thickness/mean SCT ratio (67.35 ± 11.56 and 60.66 ± 11.27, respectively), which was statistically insignificant (p = 0.08). CONCLUSION: We found a thicker choroid and Haller layer, and a greater subfoveal LCV thickness/SCT ratio on the MD side compared to the controls. Furthermore, patients with a greater duration of disease had a lower subfoveal LCV thickness/SCT ratio. These findings may reflect the role of the trigeminal vascular system (TVS) and neurovascular pathophysiology in MD patients. More extensive studies are required to reach more definitive conclusions about the association between CT and MD. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1889-1893, 2024.

Subfoveal choroidal thickness following pars plana vitrectomy in tractional diabetic macular edema.

PURPOSE: To evaluate changes in subfoveal choroidal thickness (SCT) in cases of tractional diabetic macular edema (DME) after pars plana vitrectomy (PPV). METHODS: This prospective study included 31 eyes of 31 patients who underwent PPV for the management of tractional DME. Best-corrected visual acuity (BCVA), SCT, and central macular thickness (CMT) were measured before the operation, as well as one, three, and six months following the surgery in the operated eyes and at baseline, as well as six months in the fellow eyes. RESULTS: The SCT decline in eyes with tractional DME was statistically significant six months postoperatively (P = 0.009). A statistically significant decline was observed in the CMT values one, three, and six months postoperatively in eyes with tractional DME (P = 0.02, P < 0.001, and P < 0.001, respectively). There was a statistically significant improvement in the visual acuity of the affected eyes three (P = 0.047) and six months (P = 0.017) postoperatively. CONCLUSION: After PPV for the treatment of tractional DME, a statistically significant decrease in the CMT values is detectable from the first month after surgery, followed by the improvement of BCVA from the third month. It is worth mentioning that a decrease was found in the SCT six months postoperatively.

Peripapillary Choroidal Neovascularization Type 2 With Pitchfork Sign: A Case Report.

Purpose: This study aimed to report a case of peripapillary choroidal neovascularization (CNV) with a pitchfork sign. Case Report: A young female presented with a progressive and painless visual blurring of the left eye. Ophthalmoscopic findings and results of optical coherence tomography (OCT), OCT angiography (OCTA), and fluorescein angiography (FAG) were evaluated. OCT showed subretinal hyperreflective material adjacent to the optic nerve head with multiple vertical finger-like projections extending into the outer retina (pitchfork sign). OCTA revealed that seafan-shaped high-flow vessels above the retinal pigment epithelium (RPE) were compatible with CNV type 2 with a large feeder vessel completely contiguous with the optic nerve. No evidence of ocular or systemic inflammation was found. Conclusion: Pitchfork sign can be seen in CNV type 2 in either inflammatory or noninflammatory conditions.

Update on overview of ocular manifestations of COVID-19.

The coronavirus disease 2019 (COVID-19) has become the most critical health crisis at present, and research is continued about the exact pathophysiology, presentations, and complications of this pandemic. It influences several organs, and many studies have addressed the organs, the involvement of which during the COVID-19 results in patients' death. One of the important organs that can be involved during COVID-19, which is also a transmission route of the disease, is the eye. According to the evidence, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can have ocular manifestations and complications. According to the literature, conjunctivitis is the most common presentation, which can develop at any stage of COVID-19 (during and even after the disease), and the major pathophysiology of the eye involvement during the disease is attributed to the direct effect of the virus on the eyes, tissue damage caused by inflammation, underlying diseases, and the adverse effect of the medications prescribed. There are also reports of life-threatening complications, such as rhino-orbital cerebral mucormycosis, which require urgent treatment and are associated with a great mortality rate. Ocular manifestations may also be the presentation of a life-threatening event, such as stroke; therefore, it is necessary to pay great attention to the ocular manifestations during COVID-19. In this review, after about 2 years of the pandemic started, we present a narrative review on ocular manifestations during COVID-19, categorized into three main categories; ophthalmic, orbital, and neuro-ophthalmological manifestations with a detailed description of the presenting symptoms, risk factor, diagnostic, and therapeutic strategies suggested for each.

Comparison of Pterygium Recurrence with and without Using Postsurgical Topical Cyclosporin A 0.05%: A Randomized Clinical Trial.

Purpose: To evaluate the efficacy of 3-month administration of topical cyclosporin A (CsA) 0.05% on postoperative recurrence after pterygium surgery. Methods: In this randomized clinical trial, 78 patients undergoing pterygium surgery (using the rotational conjunctival flap technique with mitomycin C [MMC]) were enrolled and randomly allocated into the control (n = 39) and case (CsA) (n = 39) groups in a single-blind method. The patients were examined on postoperative days 1, 3, and 7 and months 1, 3, and 6, and their best-corrected visual acuity, intraocular pressure, clinical inflammation, postoperative complications, and recurrence were compared. Results: The mean age of patients was 53.22 ± 9.99 years; most (57.7%) of them were men. The two groups were not different in terms of demographics, pterygium size, or pterygium grade. The clinical inflammation at the first and third postoperative months was not different between the groups (P = 0.108 and 0.780, respectively). No serious complications were detected; complication rates were not different between the groups (P = 0.99). The recurrence rate was 5.1% in the case group and 7.7%% in the control group (P = 0.99). Conclusion: The present study showed no priority for 3-month administration of CsA 0.05% drops on postoperative outcomes, including prevention of pterygium recurrence, complications, and inflammation after the rotational conjunctival autograft technique with MMC.

Spontaneous Rupture of an Infant's Cornea.

A 2-year-old boy of consanguineous parents presented with spontaneous globe rupture of the right eye that initially raised suspicions of child abuse. Other ocular and extraocular findings, a similar history of corneal rupture following minor trauma in his sibling, and genetic analysis confirmed the diagnosis of brittle cornea syndrome. [J Pediatr Ophthalmol Strabismus. 2022;59(4):e42-e45.].

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.

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.

Laser-induced macular neovascularization following accidental exposure to Alexandrite laser and excellent response to anti-VEGF: A case report.

OBJECTIVES: This study aimed to report a case of laser-induced macular neovascularization (MVN) following accidental exposure to Alexandrite laser. METHODS: A young female presented with a painless visual blurring of the right eye 25 days after direct inadvertent exposure to a single discharge from a 750-nm Alexandrite hair removal procedure. The best-corrected visual acuity (BCVA) of the right eye was finger count 3 m (M). Ophthalmoscopic findings, spectral-domain optical coherence tomography (SD-OCT), fluorescein angiography, and optical coherence tomography angiography were evaluated. RESULTS: Fundus examination of the right eye revealed intraretinal hemorrhage and a round yellow-grayish subretinal lesion just beneath the fovea. SD-OCT of the right eye showed retinal thickening, subretinal hyperreflective lesion, subretinal and mild intraretinal fluid, and a small retinal pigment epithelium defect beneath the fovea. Optical coherence tomography angiography demonstrated MNV type 2. After the administration of intravitreal injection of three monthly anti-vascular endothelial growth factor, BCVA improved to 20/20.

Evaluation of Choroidal Thickness during Pregnancy and Postpartum: A Longitudinal Study.

Purpose: To assess the longitudinal changes of choroidal thickness using enhanced depth imaging optical coherence tomography (EDI-OCT) during pregnancy and postpartum. Methods: The study included 23 eyes of 23 healthy pregnant women and 23 eyes of 23 healthy nonpregnant women. Choroidal thickness was measured manually with EDI-OCT at seven locations: The fovea, 500, 1000, and 1500 µm temporal (T) from the fovea and 500, 1000, and 1500 µm nasal (N) from the fovea. Measurements were obtained at each pregnancy trimester and 6 weeks postpartum and in the follicular phase of the menstrual cycle for the control group. Results: The mean subfoveal choroidal thickness was 410.2 ± 82.4 µm, 434.8 ± 79.6 µm, 433.5 ± 80.3 µm, and 395.0 ± 71.1 µm in the first, second, and third trimesters and 6 weeks postpartum, respectively. In all seven measured locations, statistically significant changes were noted during pregnancy and postpartum in the choroidal thickness (P < 0.001). Choroidal thickness increased from the first trimester to the second and third trimester, after which it decreased at postpartum. Choroidal thickness was greater in the pregnant group during pregnancy and postpartum compared to the control group (P < 0.001). Conclusions: This study indicated significant change in choroidal thickness at seven locations measured with EDI-OCT throughout pregnancy and 6 weeks after delivery. We showed that 6 weeks after delivery, choroidal thickness remains significantly higher than nonpregnant subjects.

Macular Optical Coherence Tomography before Cataract Surgery.

PURPOSE: To determine the benefits of performing preoperative spectral domain optical coherence tomography (SD-OCT) and to identify occult macular pathologies in patients scheduled for routine cataract surgery. METHODS: In this cross-sectional study, macular SD-OCT scans were performed on all patients with clinically undetected macular abnormalities who were scheduled for cataract surgery. Patients with clinically evident macular abnormalities were excluded from the study. A retinal specialist reviewed all the scans. The severity of the cataract was determined using the Oxford Clinical Cataract Classification and Grading System. RESULTS: Of the 598 evaluated cases, 33 patients (5.52%) had an occult macular abnormality. The most common pathology found in these patients was idiopathic epiretinal membrane, which was detected in 17 eyes (51.52%), followed by vitreomacular traction in nine eyes (27.27%), and dry age-related macular degeneration in four eyes (12.12%). Full-thickness macular holes and a lamellar macular hole were found in two patients (6.06%) and one patient (3.03%), respectively. The frequency of cortical cataracts was significantly lower in patients without macular lesions (P = 0.012) than in those with macular lesions. Multivariate logistic regression analysis revealed that age >70 years (P = 0.025 and odds ratio [OR] =11.12), smoking history (P = 0.043 and OR = 3.43), and hypertension were independently associated with occult macular lesions. The surgical plan was changed for five patients (0.83%). CONCLUSIONS: Macular SD-OCT can be used to detect occult macular lesions and provide useful information about a macula before cataract surgery. Although preoperative OCT found macular abnormalities in about 5% of patients with presumed normal fundus examination, it can result in changing the surgical plan in 0.83% of all patients.