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
To use spectral domain optical coherence tomography [OCT] to assess the features of the inner and outer layers of the macula in subjects with retinitis pigmentosa [RP]. Design: Prospective observational comparative study. Subjects with RP with reduced central visual acuity and central macular thinning [RP group] underwent spectral domain OCT evaluation along with age-matched healthy control subjects [control group]. Using the E-MM5 raster protocol, a 5-5 mm central macular cut was acquired with inner and outer macular volumes serving as the primary outcome measures. A structural analysis of the inner and outer retinal layers at the macula in the RP group was also performed using the HD cross-line protocol. The RP group comprised six eyes of six RP subjects and control group comprised six eyes of six control subjects. The outer macular volume was significantly lower [P<0.05] in the RP group [2.01 +/- 0.44 mm [3]] compared to the control group [4.68 +/- 0.16 mm [3]]. There was no difference in the mean inner macular volume between the RP group [2.46 +/- 0.24 mm [3]] and the control group [2.55 +/- 0.22 mm [3]]. No significant structural alteration was noted in the inner retinal layers of the RP group. There was no significant correlation [r=-0.04, P>0.05] between best-corrected visual acuity and outer macular volume in the RP group. Conclusions: Spectral domain OCT findings confirm that RP preferentially affects the outer retinal layers in the macula. Although the number of patients included in this study was small, it demonstrated relatively well-preserved volume and morphology of the inner retinal layers using spectral domain OCT