ABSTRACT
Purpose: The purpose of the study was to evaluate the knowledge and perception of health-care professionals (HCPs), such as doctors/surgeons, pharmacists, nurses, optometrists, and lab technicians, on clinical trials (CTs) in India. Methods: The study was a pan-Indian cross-sectional survey initiated by the Indian Ophthalmology Clinical Trial Network (IOCTN) by using a previously validated questionnaire for three months of data collection. An online survey was used to record information regarding demographics, CT knowledge, and CT perception among HCPs. Results: A total of 630 responses were recorded from HCPs: 207 doctors and surgeons, 159 pharmacists, and 264 laboratory technicians, nurses, and optometrists across India. Over 90% of HCPs had a clear knowledge on the purpose of CTs, the informed consent (IC) process, ethical approval by the Drugs Controller General of India (DCGI). About 80% and 90% were aware of confidentiality of patients, voluntariness of participation, and good clinical practice. Surprisingly, less than 50% had lesser knowledge regarding monetary incentives of CT participants (CTPs). A slightly positive perception was observed regarding the potential benefits of CTPs, compensation related to injury, and importance of obtaining IC. Less than 50% had a negative perception that monetary compensation to CTPs led to bias and deprivation of standard treatments. However, no significant difference was observed between other aspects of demographics and perception regarding CTs. Conclusion: We observed doctors and surgeons to be having the highest regarding CTs, followed by pharmacists. The survey highlighted the necessity of scheduling awareness programs among the HCPs, which would improve their misconceptions and perception of CTs while interacting with patients for CT enrollment.
ABSTRACT
Purpose: Our aim was to determine the various risk factors for secondary ocular hypertension (OHT) following pars plana vitrectomy (PPV) with silicone oil (SO) injection. Methods: A prospective cohort study was performed on 46 eyes of 42 patients who underwent PPV with SO injection under a single surgeon between January 2020 and July 2021. Complete ophthalmological examination including gonioscopy and Goldmann applanation tonometry was performed preoperatively and on three postoperative visits, that is, day 7, day 30, and day 90. Axial length and lens thickness were measured at baseline using immersion A?scan. Anterior segment optical coherence tomography (OCT) was used for measuring anterior chamber depth (ACD) at baseline and at 3 months. Results: There was a statistically significant increase in intraocular pressure (IOP) (>21 mmHg) on day 7 (4.70 ± 7.754 mmHg), day 30 (5.24 ± 7.481 mmHg), and day 90 (2.39 ± 5.659 mmHg) (P<0.01 for all). Age <50 years, rhegmatogenous retinal detachment (RRD), and pseudophakia had a strong association with short?term OHT on day 7. Preexisting glaucoma was the only independent risk factor for long?term OHT (day 90). Higher baseline IOP and SO emulsification also contributed to long?term OHT. Conclusion: There was a statistically significant elevation in IOP at all postoperative visits. Short?term OHT was associated with younger age (<50 years), RRD, and pseudophakia. Patients with emulsified SO in the anterior chamber, higher baseline IOP, and preexisting glaucoma were at higher risk for long?term OHT.
ABSTRACT
Purpose: Our primary aim was to evaluate intraocular cytokines (IC) before and after dexamethasone in diabetic macular edema (DME). Our secondary aim was to study the early and late effects of single dexamethasone implant in DME. Methods: This before and after comparative study was conducted at the Department of Ophthalmology and Centre for Nanosciences at a quaternary referral center in Kerala, India, from September 2016 to September 2018. Patients underwent complete ophthalmological examination and cytokine analysis before and after dexamethasone implant. Levels of cytokines at baseline and repeat sample were studied. Results: Twenty?seven eyes (21 patients) were divided into two groups depending on time from baseline to second injection. Group 1 included patients with <3 months between the two samples – 12 (44.4%). Group 2 included patients with >3 months between the two samples –15 (55.6%). Best corrected visual acuity (BCVA) and central macular thickness (CMT) improved significantly post?dexamethasone in group 1, but not in group 2. Interleukin (IL)?4, IL?6, IL?10, vascular endothelial growth factor (VEGF), IL?1?, interferon?gamma inducible protein?10 (IP?10), monocyte chemoattractant protein?1 (MCP?1), and IL?2 decreased post?injection in group 1. But cytokines increased post?dexamethasone in group 2, except IL?10. When compared to baseline, IL?6 reduced to half in group 1 (P?value 0.814) and it tripled in group 2 ( P?value 0.009). The level of VEGF in the first and second samples was not different in either group. Conclusion: Our study suggests that dexamethasone acts more on IC than VEGF in DME. This is significant in the first 3 months with a rebound effect on IL?6 after 3 months. Our study also suggests that repeat injection of DEX in DME should be done at 3 months to prevent deterioration of visual acuity (VA) and worsening of CMT.