# Development of the First-ever Safe and Effective Anterior Chamber Paracentesis Instrument to Treat and Diagnose Ocular Diseases

> **NIH NIH R43** · F SQUARE MEDICAL LLC · 2021 · $293,556

## Abstract

PROJECT SUMMARY
Despite advances in the treatment of ocular diseases, vision threatening disease or eye injury remain the top 10
disabilities among adults. Several of these ocular conditions require an anterior chamber paracentesis (ACP).
ACP is clinically indicated to reduce acutely elevated intraocular pressure (IOP) to avoid risk of permanent vision
loss and to sample aqueous humor for disease diagnostics and monitoring. Conditions requiring IOP reduction
include acute angle closure glaucoma, pneumatic retinopexy to treat retinal detachments, and iatrogenic IOP
elevations associated with intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents to
treat diseases such as neovascular age-related macular degeneration, diabetic retinopathy and retinal vein
occlusions. Conditions requiring aqueous humor sampling include uveitis, retinoblastoma and lymphoma, and
aqueous biomarkers increasingly are guiding treatment selection and drug monitoring, e.g., with anti-VEGF
agents. Unfortunately, there exists no instrument specifically designed for ACP, and instead tuberculin syringes
with standard excessively long needles are used. This requires a steady surgeon hand and steady patient eye
while the patient is positioned in the slit lamp biomicroscope. As a result, the ACP procedure may lead to serious
complications such as hyphema and cataract due to inadvertent trauma to intraocular structures (e.g., cornea,
ciliary body, iris and lens), and the aspiration rate and aqueous volume is difficult to control and unpredictable.
As a result, there have been no improvements in the safety or efficiency of ACP in the past century. To overcome
the limitations associated with existing antiquated techniques, F Square Medical is developing and
commercializing the first-ever instrument designed specifically for ACP procedures. The Parasafe instrument is
a sterile, disposable, light-weight and importantly, safe instrument for rapid and reproducible ACP. In this Phase
I SBIR proposal we will: 1) work with an experienced USA-based contract engineering and prototyping firm,
Gilero, to refine the design and manufacture a Parasafe prototype, 2) conduct summative evaluation human
factors studies, and 3) assess the functionality of the Parasafe with practicing ophthalmologists and an ex vivo
porcine model. The completion of the proposed aims will result in verification and validation of an instrument that
will significantly reduce the risk of injury associated with ACP while optimizing functionality of the procedure and
advancing this transformational instrument to the next phase of commercialization.

## Key facts

- **NIH application ID:** 10325880
- **Project number:** 1R43EY032825-01A1
- **Recipient organization:** F SQUARE MEDICAL LLC
- **Principal Investigator:** samer farah
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $293,556
- **Award type:** 1
- **Project period:** 2021-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10325880

## Citation

> US National Institutes of Health, RePORTER application 10325880, Development of the First-ever Safe and Effective Anterior Chamber Paracentesis Instrument to Treat and Diagnose Ocular Diseases (1R43EY032825-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10325880. Licensed CC0.

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