Overview

BSC provides statistical expertise for ophthalmic devices and therapeutics, including intraocular lenses (IOLs), refractive surgery systems, glaucoma treatments, and retinal disease management technologies. Our experience spans both surgical and diagnostic ophthalmology devices.

Specialized Capabilities

Visual acuity endpoint design (ETDRS, logMAR). Handling of inter-eye correlation in bilateral studies. Non-inferiority margin justification for ophthalmic devices. Intraocular pressure modeling for glaucoma devices. Retinal imaging endpoint assessment.

Regulatory Experience

We understand ophthalmology division expectations for vision endpoint assessment, including appropriate vision testing protocols, handling of fellow-eye effects, and long-term safety monitoring for implantable devices. Our team has successfully navigated discussions around appropriate comparators and study designs.

Representative Studies

• Intraocular lenses, IOLS, (monofocal, multifocal, toric)

• Glaucoma drainage devices and minimally invasive procedures

• Laser refractive surgery systems

• Retinal treatment devices and drug delivery systems

• Ophthalmic diagnostic imaging devices