Hyderabad: LV Prasad Eye Institute (LVPEI) has received ISO 13485:2016 certification for the manufacture of Boston Sight SCLERAL and PROSE (prosthetic replacement of the ocular surface ecosystem) lenses following review by the British Standards Institute (BSI). The ISO certification ensures that the LVPEI’s quality management system meets current global regulatory requirements that are specific to the medical device industry.
“These special contact lenses offer the promise of relief for people afflicted with many problems of the cornea not treatable otherwise. We are delighted that we could make this service available in India,” Dr Gullapalli N Rao, Founder and Chair, LVPEI said.
The Boston Sight SCLERAL and PROSE lens manufacturing facility was established at LVPEI in 2017 in collaboration with Boston Foundation for Sight with an aim to increase the access of these specialized lenses to patients in underserved geographies. These lenses restore visual function, support healing, reduce symptoms, avoid corneal transplantation in some cases and improve quality of life for patients suffering with ocular surface disease, corneal disease, injury or damage. The facility has served more than 1,500 patients across India and will soon start catering to patients in South-East and Middle-East Asia.
Scleral lenses are commonly known for their use in patients with Stevens-Johnson syndrome, keratoconus, corneal grafts, chemical and thermal burn injuries, and ocular pemphigoid, among other uses. However, the increased spotlight on scleral lenses has led to their use in more number of patients with severe dry eyes due to Sjögren’s syndrome, autoimmune diseases, chronic graft-versus-host disease, post-LASIK dry eye, and irregular astigmatism, a press release added.