Focus of the Report: This health technology assessment focuses on the use of the BostonSight prosthetic replacement of the ocular surface ecosystem (PROSE) treatment for primary or secondary dry eye disease (DED) in adults and pediatric patients.

Technology Description: BostonSight PROSE treatment includes a fully individualized, customizable prosthetic, transparent dome made of highly gas-permeable hard plastic, fluorosilicone/acrylate polymers, and either oprifocon A or hexafocon B. The prosthetic device used in PROSE treatment is approximately the size of a nickel, between 13 and 23 millimeters in diameter. 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 treatment 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 adult and pediatric patients?

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