Health Problem: Dry eye disease (DED), a subset of ocular surface disorders, is a group of tear film disorders attributed to reduced tear production or excessive tear evaporation. It is associated with ocular discomfort and visual symptoms. DED may result in considerable disability and may lead to loss of vision in more severe cases; and may threaten the outcomes of refractive, cataract, and corneal surgery.
Technology Description: BostonSight prosthetic replacement of the ocular surface ecosystem (PROSE) treatment includes a fully individualized, customizable prosthetic transparent dome made of highly gas-permeable hard plastic, fluorosilicone/acrylate polymers, either oprifocon A or hexafocon B. The prosthesis fits under the eyelid, resting on the sclera to form a surface over the cornea and provide an artificial tear reservoir. The space between the prosthetic device and the cornea is filled with sterile saline.
Controversy: Controversies exist regarding the effectiveness of BostonSight PROSE treatment for alleviating symptoms of severe refractory DED, patient selection criteria, how BostonSight PROSE treatment compares with alternative therapies in head-to-head comparisons, whether BostonSight PROSE precludes the need for alternative interventions, and the cost-effectiveness of treatment.
Key Questions:
- Is BostonSight PROSE treatment effective in treating DED in adults and pediatric patients?
- How does BostonSight PROSE treatment compare with other treatments for DED?
- Is BostonSight PROSE treatment safe for the treatment of DED in adults and pediatric patients?
- Have definitive patient selection criteria been identified for the use of BostonSight PROSE treatment for DED in adults and pediatric patients?
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