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

> **NIH NIH R44** · F SQUARE MEDICAL LLC · 2024 · $1,093,927

## 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 endophthalmitis, 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 and limited operational control are used. This requires
a steady surgeon hand and steady patient eye while the patient is positioned in the slit lamp biomicroscope, and
often requires an assistant. 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 are difficult to control and unpredictable. Unfortunately, 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 Parasafe™, the first-ever
instrument designed specifically for ACP procedures. The Parasafe instrument is a sterile, disposable and
importantly, safe instrument for controlled, rapid, and reproducible ACP without requiring a slit lamp or an
assistant. Through the completion of a successful Phase I project, F Square Medical built a functional alpha
prototype and assessed its performance and usability to inform beta prototype refinement. This Phase II program
will build upon the substantial Phase I data package and will focus on incorporating feedback from the Phase I
end-user data to refine and lock the Parasafe design for manufacture, as well as execute on the complete array
of required design control activities per 21 CFR 820.30 to advance Parasafe to FDA regulatory 510(k)
submission, approval, and scalable production. The completion of the proposed Phase II project will result in the
filing of a 510(k) regulatory submission to the FDA for Parasafe, an instrument with the potential to significantly
reduce the risk and expand the utility of ACP, thereby advancing this transformational instrument toward...

## Key facts

- **NIH application ID:** 10915425
- **Project number:** 5R44EY032825-03
- **Recipient organization:** F SQUARE MEDICAL LLC
- **Principal Investigator:** samer farah
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,093,927
- **Award type:** 5
- **Project period:** 2021-09-01 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10915425

## Citation

> US National Institutes of Health, RePORTER application 10915425, Development of the First-ever Safe and Effective Anterior Chamber Paracentesis Instrument to Treat and Diagnose Ocular Diseases (5R44EY032825-03). Retrieved via AI Analytics 2026-05-29 from https://api.ai-analytics.org/grant/nih/10915425. Licensed CC0.

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