Data sharing implementation in top 10 ophthalmology journals in 2021.

BACKGROUND/AIMS: Deidentified individual participant data (IPD) sharing has been implemented in the International Committee of Medical Journal Editors journals since 2017. However, there were some published clinical trials that did not follow the new implemented policy. This study examines the number of clinical trials that endorsed IPD sharing policy among top ophthalmology journals. METHOD: All published original articles in 2021 in 10 highest-ranking ophthalmology journals according to the 2020 journal impact factor were included. Clinical trials were determined by the WHO definition of clinical trials. Each article was then thoroughly searched for the IPD sharing statement either in the manuscript or in the clinical trial registry. We collected the number of published clinical trials that implemented IPD sharing policy as our primary outcome. RESULTS: 1852 published articles in top 10 ophthalmology journals were identified, and 9.45% were clinical trials. Of these clinical trials, 44% had clinical trial registrations and 49.14% declared IPD sharing statements. Only 42 (48.83%) clinical trials were willing to share IPD, and 5 (10.21%) of these share IPD via an online repository platform. In terms of sharing period, 37 clinical trials were willing to share right after the publication and only 2 showed the ending of sharing period. CONCLUSION: This report shows that the number of clinical trials in top ophthalmology journals that endorsed the IPD sharing policy and the number of registrations is lower than half even though the policy has been implemented for several years. Future updates are necessary as policy evolves.

Optical Coherence Tomography Angiography Biomarkers in Thai Patients With Diabetic Nephropathy: A Diabetic Eye and Kidney Diseases (DEK-D) Study.

Purpose: To identify optical coherence tomography angiography (OCTA) biomarkers to predict the diabetic nephropathy (DN) and their associations with 24-hour urine albumin levels in diabetic patients. Methods: This cross-sectional, observational study examined 186 eyes from 93 individuals subdivided into three groups according to 24-hour urine albumin levels: no DN, early DN, and late DN. Vessel density (VD), fractal dimension, foveal avascular zone area, intercapillary area, central retinal thickness, and subfoveal choroidal thickness were measured from OCTA images to determine their association with the DN stages. Results: VD values of the superficial capillary plexus, deep capillary plexus, and whole retina were significantly lower in the early DN group compared to the no DN group (adjusted P = 0.042, 0.016, and 0.008, respectively). VD values for the deep capillary plexus and whole retina were significantly decreased in the late DN group compared to the no DN group (adjusted P = 0.025 and 0.021, respectively). Mean fractal dimension, intercapillary area, foveal avascular zone area, central retinal thickness, and subfoveal choroidal thickness were not statistically different among the three groups. Conclusions: VD may be a useful parameter for the early non-invasive screening of DN. Further studies in larger populations are needed to establish a cutoff value for detection. Translational Relevance: This study investigated the association of each retinal vasculature measurement by OCTA and diabetic nephropathy status which could serve as an alternative way to screen for albuminuria.

The sterility, stability and efficacy of repackaged ziv-aflibercept for intravitreal administration.

To evaluate the sterility, stability, and efficacy of repackaged ziv-aflibercept in 1-mL plastic tuberculin syringes for intravitreal injection after storage for up to 90 days at controlled (4 °C) and ambient (25.8 °C) temperature. A total of 168 tuberculin-type 1-mL syringes were prepared containing ziv-aflibercept (100 mg/4 mL). Samples were stored at 4 °C and 25.8 °C for 0, 3, 7, 14, 21, 28, 60, and 90 days. At each time point, four samples were evaluated for the stability and binding affinity of anti-VEGF to VEGF (efficacy) using enzyme-linked immunosorbent assays (ELISAs). All samples were analyzed for microbial growth. No microbial growth was obtained from any of the ziv-aflibercept samples during each time point, indicating that the repackaged ziv-aflibercept stored at 4 °C and 25.8 °C remained sterile. ELISA analysis revealed no significant decrease in concentration, and binding affinity was observed, indicating that the stability and efficacy were preserved. However, the concentration of ziv-aflibercept decreased less than the minimum expected concentration of 8 ng/mL after 60 days at 4 °C and after 30 days at 25.8 °C. The repackaged anti-VEGF drug ziv-aflibercept does not lose stability or efficacy and remains uncontaminated if prepared under sterile conditions and stored at 4 °C for up to 60 days or stored at 25.8 °C for up to 30 days.

Outcomes of Pre-Early Treatment for Retinopathy of Prematurity (Pre-ETROP).

INTRODUCTION: The earlier treat stage 3 ROP is more likely to achieve better outcomes. PRIMARY PURPOSE: To study the unfavorable outcomes and regression after pre-early treatment for ROP. SECONDARY PURPOSE: To evaluate the progression and recurrence of ROP requiring retreatment after pre-early treatment for ROP. PATIENTS AND METHODS: The data were retrieved retrospectively from the medical records of all infants who were screened and treated for ROP from January 2009 to January 2014 at a tertiary care facility. The outcomes measured the following: 1. unfavorable outcomes; 2. regression of ROP; 3. progression of ROP and 4. recurrence of ROP requiring retreatment. We treated all stage 3 ROP in any zone, with or without plus. The study also compared the outcomes between the pre-ETROP and the ETROP subgroups. RESULTS: There were 91 eyes with stage 3 ROP. Of the total of 91 eyes, there were 63 eyes with the pre-ETROP group and 28 eyes of the ETROP group. The unfavorable outcomes after treatment occur 6 eyes from 28 eyes (21.43%) in the ETROP group but no unfavorable outcomes in the pre-ETROP group (P=0.001). The pre-ETROP group who were treated with laser LIO alone had 100% regression, while the ETROP group who were treated with LIO (26 eyes) had 88.46% regression. There were 2 eyes of this group who were treated with a combination of LIO and IVT Bevacizumab. Both of them did not have regression. The recurrence of ROP requiring retreatment occurred in 2 eyes (7.14%) of the ETROP group, but no recurrence in the pre-ETROP group (P=0.092). The progression after treatment occurred in 3 eyes (10.71%) in the ETROP group, but no progression in the pre-ETROP group (P=0.027). CONCLUSION: The pre-ETROP treatment is useful for reducing unfavorable outcomes and increasing the regression of ROP. Further, the treatment can reduce the recurrence of neovascularization and progression after treatment.

A real-world study of effectiveness of intravitreal bevacizumab and ranibizumab injection for treating retinal diseases in Thailand.

BACKGROUND: To evaluate the effectiveness of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) in actual practice for treating patients with retinal diseases in Thailand. METHODS: A prospective, multi-centre, observational study was conducted among eight hospitals in their ophthalmology outpatient departments. Participants consisted of patients who had previously not received any IVB or IVR treatment between 2013 and 2014. The primary outcome measurement was the change in best-corrected visual acuity (BCVA) at the end of the follow-up period compared to baseline. RESULTS: There were 1629 treatment-naïve patients for the pro re nata (PRN) treatment pattern and 226 treatment-naive patients for the three-injections (3Inj) treatment pattern. BCVA improvements were found in 35% of the PRN group and 47% of the 3Inj group; however, it was not clinically meaningful between the IVB and IVR groups (P-value = 0.568 for PRN, P-value = 0.103 for 3Inj). A multivariable logistic regression (using the propensity score) showed that positive factors associated with vision improvement for the PRN pattern were the number of drug injections, having retinal vein occlusion, and under 60 years of age, while good BCVA at baseline was a negative predictive factor. For the 3Inj pattern, under 60 years of age and baseline BCVA were statistically significant predictors. Nonetheless, diabetes mellitus (DM) without other comorbidities was a statistically significant predictor of low response to vision improvement compared to DM with other comorbidities. CONCLUSIONS: This study was the first observational, prospective study to evaluate the real-life effectiveness of IVB and IVR in Thailand. The majority of participants who used IVB or IVR showed improvements in BCVA after treatment. Further evaluation such as long-term follow-ups and subsequent comparison of effectiveness between IVB and IVR should be investigated due to the limited sample of IVR patients. TRIAL REGISTRATION: Thai Clinical Trial Registry TCTR20141002001 . Registered 02 October 2014 (retrospectively registered).

Correction to: Real-World Safety of Intravitreal Bevacizumab and Ranibizumab Treatments for Retinal Diseases in Thailand: A Prospective Observational Study.

The Open Access license, which previously read.

Real-World Safety of Intravitreal Bevacizumab and Ranibizumab Treatments for Retinal Diseases in Thailand: A Prospective Observational Study.

BACKGROUND: There is very limited evidence examining serious systemic adverse events (SSAEs) and post-injection endophthalmitis of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) treatments in Thailand and low- and middle-income countries. Moreover, findings from the existing trials might have limited generalizability to certain populations and rare SSAEs. OBJECTIVES: This prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand. METHODS: Between 2013 and 2015, 6354 patients eligible for IVB or IVR were recruited from eight hospitals. Main outcomes measures were prevalence and risk of SSAEs, mortality, and endophthalmitis during the 6-month follow-up period. RESULTS: In the IVB and IVR groups, 94 and 6% of patients participated, respectively. The rates of outcomes in the IVB group were slightly greater than in the IVR group. All-cause mortality rates in the IVB and IVR groups were 1.10 and 0.53%, respectively. Prevalence rates of endophthalmitis and non-fatal strokes in the IVB group were 0.04% of 16,421 injections and 0.27% of 5975 patients, respectively, whereas none of these events were identified in the IVR group. There were no differences between the two groups in the risks of mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF). Adjustment for potential confounding factors and selection bias using multivariable models for time-to-event outcomes and propensity scores did not alter the results. CONCLUSIONS: The rates of SAEs in both groups were low. The IVB and IVR treatments were not associated with significant risks of mortality, ATE, and non-fatal HF. TRIAL REGISTRATION: Thai Clinical Trial Registry identifier TCTR20141002001.

Real-World Simulation of an Alternative Retinopathy of Prematurity Screening System in Thailand: A Pilot Study.

PURPOSE: To evaluate an alternative retinopathy of prematurity (ROP) screening system that identifies infants meriting examination by an ophthalmologist in a middle-income country. METHODS: The authors hypothesized that grading posterior pole images for the presence of pre-plus or plus disease has high sensitivity to identify infants with type 1 ROP that requires treatment. Part 1 of the study evaluated the feasibility of having a non-ophthalmologist health care worker obtain retinal images of prematurely born infants using a non-contact retinal camera (Pictor; Volk Optical, Inc., Mentor, OH) that were of sufficient quality to grade for pre-plus or plus disease. Part 2 investigated the accuracy of grading these images to identify infants with type 1 ROP. The authors prospectively recruited infants at Chulalongkorn University Hospital (Bangkok, Thailand). On days infants underwent routine ROP screening, a trained health care worker imaged their retinas with Pictor. Two ROP experts graded these serial images from a remote location for image gradability and posterior pole disease. RESULTS: Fifty-six infants were included. Overall, 69.4% of infant imaging sessions were gradable. Among gradable images, the sensitivity of both graders for identifying an infant with type 1 ROP by grading for the presence of pre-plus or plus disease was 1.0 (95% confidence interval [CI]: 0.31 to 1.0) for grader 1 and 1.0 (95% CI: 0.40 to 1.0) for grader 2. The specificity was 0.93 (95% CI: 0.76 to 0.99) for grader 1 and 0.74 (95% CI: 0.53 to 0.88) for grader 2. CONCLUSIONS: It was feasible for a trained non-ophthalmologist health care worker to obtain retinal images of infants using the Pictor that were of sufficient quality to identify infants with type 1 ROP. [J Pediatr Ophthalmol Strabismus. 2018;55(4):245-253.].

Trials registration: a new era in Thailand.

Registration of clinical trials or research can result in many benefits. Patients have access to pertinent information. We have a better and more indicative picture of research status in areas where registration is mandatory. Researchers can use the information to form a common interest group and collaborate their research as well as to avoid unnecessary duplication. Registered information can also enable detection of defective design and can lead to improvements of trial protocol or its implementation. Most importantly, it can help to reduce problems of publication bias and selective reporting. Journals do not like to publish negative or inconclusive results. Pharmaceutical companies are reluctant to report results that may jeopardize their revenue. We need absolute transparency to utilize evidence with trust.

Thai clinical trials registry.

The Thai Clinical Trials Registry (TCTR) was established in 2009 by a group of university academics. The Thailand Center of Excellence for Life Sciences has supported the registry financially, while the basic infrastructure including the administration, staff and computer servers has been provided by the Clinical Research Collaboration Network and the Medical Research Foundation. In December 2010, the Ministry of Public Health of Thailand endorsed the registry. In addition to the major purposes of reducing publication bias, promoting research transparency, and reducing redundancy in clinical research, TCTR aims to create a collective database of the clinical researches in Thailand, in order to help construct a pool database for local researchers.

Combined deep topical and superior subconjunctival anesthesia for extracapsular cataract extraction in a rural eye camp.

BACKGROUND: Anesthesia for cataract surgery at eye camps needs to be simple, safe, and effective. METHODS: We prospectively studied 98 patients undergoing cataract extraction in a rural eye camp in Thailand. Patients undergoing extracapsular cataract extraction with intraocular lens implantation (ECCE/IOL) received deep topical anesthesia with subconjunctival anesthesia. Patients undergoing phacoemulsification with intraocular lens implantation (Phaco/IOL) received topical anesthesia. Pain visual analog score, operative and anesthetic complications, operative time, and additional medications were recorded. RESULTS: A mean age of 68.7 vs 67.5 yr, an operative time of 16.1 +/- 6.7 min vs 12.0 +/- 4.7 min, and a median (interquartile range) pain score of 30.5 mm (12.3-54.6 mm) vs 20.0 mm (9.0-45.9 mm) were seen in the ECCE/IOL and Phaco/IOL groups, respectively. Three cases of ruptured posterior capsule occurred in the Phaco/IOL group. No additional anesthesia was needed. No anesthetic complications occurred. CONCLUSION: In a rural eye camp, deep topical anesthesia with subconjunctival anesthesia for ECCE/IOL and topical anesthesia for Phaco/IOL provide effective anesthesia for cataract surgery.

An unusual complication from esthetic injection of liquid silicone into the forehead.

PURPOSE: To report a case of migration of liquid silicone into the upper eyelid. DESIGN: Interventional case report. METHODS: A 32-year-old woman had an injection of liquid silicone into the subcutaneous tissue of the forehead. She developed a cystic mass in the upper eyelid 2 days postinjection. An excisional biopsy was performed. RESULTS: The mass lay in the Müller's muscle, and its base adhered to the tarsus. The mass ruptured during dissection, revealing a yellowish turbid fluid. Histopathologic findings showed lipogranulomatous reaction. CONCLUSIONS: Liquid silicone injection to the forehead may promote formation of a cystic mass in the upper eyelid.