Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study

Clinical SAE Case Study

During the COVID-19 pandemic, Techsol was in the process of conducting an Ophthalmology related intraocular lens study for the correction of Aphakia. A 49 -year-old Asian Subject earlier diagnosed with Nuclear Sclerosis Grade II Cataract in both eyes, was screened and selected for the study per the inclusion and exclusion criteria. With a medical history of controlled hypertension, the Subject underwent cataract extraction and intraocular lens implantation as part of the ophthalmology study procedure. After the planned post-operative visit, the Subject reported redness, pain and itching on and off in the right eye to the Principal Investigator (PI) through a telephonic call because of the local travel restrictions mandated by the Indian government.

To ensure timely data capture and evaluation of the adverse event experience, the site investigator team arranged a video call and evaluated the subject’s safety and confirmed the condition as cystoid macular edema (CME) with reference to the approved clinical study protocol. On the same day, the Site Team also facilitated the Subject’s visit to the site with an ambulance for further medical assessment to complete the event classification and to examine the safety and overall well-being.

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