Statement of Need.pdf

NEI Statement of Need (SON): Fully integrated dual YAG/SLT ophthalmic laser system with associated accessories

Background and Justification The National Institutes of Health (NIH), National Eye Institute (NEI), Ocular Genomics and Visual Function Branch (OGVFB), Translational Research Core (TRC)’s mission is the invention, validation, and refinement of new surgical techniques, new therapeutic uses of existing technologies, and new large-animal models that more faithfully replicate human degenerative eye disease and surgical complications. To continue to advance this mission the TRC requires the purchase of a fully integrated dual YAG/SLT ophthalmic laser system with associated accessories. This equipment will be used to support both ongoing clinical procedures and high-impact translational research projects involving porcine surgical models. The NEI requires a (new, replacement) dual therapeutic laser system for development of novel ophthalmic surgical techniques, treatment paradigms, and animal models of degenerative eye disease using porcine eyes.

In this context, Nd:YAG laser use extends well beyond conventional indications such as posterior capsulotomy. Our research program includes novel and exploratory applications of YAG photodisruption, including but not limited to:

• Modulation or release of post-surgical fibrotic scars

• Management of tractional elements following experimental surgical interventions

• Precise disruption of tissue interfaces created intentionally as part of model development

• Evaluation of laser-tissue interactions under altered biomechanical and optical conditions

These applications are performed in pig eyes, which differ substantially from human eyes in ways that critically affect laser delivery. Porcine eyes have a larger lens, different lens power, altered anterior segment geometry, and different spatial relationships between cornea, iris, lens, and target tissues. These differences fundamentally change the focal plane geometry for Nd:YAG photodisruption.

Because our work involves new surgical concepts and non-standard targets, procedures cannot be "tuned once" or executed using fixed, human-optimized laser settings. Instead, success depends on the ability to continuously and precisely adjust laser parameters, particularly focal offset, to position optical breakdown exactly at the intended tissue plane while minimizing total delivered energy.

A laser system lacking sufficient flexibility in focal offset and energy control would force compromises that increase the risk of collateral tissue damage, invalidate experiments, and directly increase animal use. Therefore, extended and continuous parameter adjustability is not a preference but a scientific necessity for this research program.

Statement of minimum system capability requirements:

(Bold indicates features that are uniquely or disproportionately critical)

To meet the needs of inventive surgical research in pig models, the ophthalmic laser system must deliver the following critical operational capabilities:

1. Wide, continuous anterior and posterior Nd:YAG focal offset adjustment sufficient to compensate for porcine ocular anatomy and experimental variability without increasing pulse energy.

As a critical differentiator, the laser system must be capable of wide and continuous YAG offset adjustment which support a continuous anterior/posterior Nd:YAG offset range of up to +/-500 um, allowing precise displacement of the photodisruption focal point relative to the aiming beam and ocular structures.

This capability is decisive for pig eye work. The larger porcine lens and altered optical power frequently require offset values well beyond what is sufficient in human eyes. Continuous adjustment allows the operator to place plasma formation exactly at the desired tissue interface rather than accepting a coarse approximation.

By contrast, commonly available alternative YAG/SLT systems provide only a small number of discrete offset positions (for example, -150 um, +30 um, +150 um). In pig eyes, these discrete steps are often insufficient, forcing the operator to compensate by increasing energy or accepting suboptimal focal placement.

This limitation cannot be mitigated by technique or training and represents a hard functional constraint and establishes one of the most critical minimum requirements for final purchase. Laser systems which fail to meet this specification will be deemed technically unacceptable.

2. Fine-grained, stable Nd:YAG energy control enabling consistent plasma formation at low energy levels.

3. High-precision aiming and small YAG spot size appropriate for delicate, non-standard anterior segment targets.

The laser system must support fine control of multiple interdependent parameters, including:

• Nd:YAG energy range from approximately 0.3 to 10 mJ, continuously adjustable

• Small YAG spot size (approximately 8 um) for localized photodisruption

• Selectable burst modes (1, 2, or 3 pulses) allowing controlled energy delivery tailored to tissue response

This combination is particularly important for novel applications where tissue response is being studied or optimized. In experimental settings, the ability to adjust offset, energy, and burst structure independently allows researchers to explore safe operating envelopes without exceeding damage thresholds.

Systems with coarser control or fewer adjustable dimensions inherently limit experimental design and force higher-energy operation, which is incompatible with our research goals.

4. Combined Nd:YAG and SLT capability in a single, integrated platform, avoiding workflow disruption, optical re-registration errors, and inter-device variability.

5. Operational reliability and calibration stability suitable for scheduled large-animal experiments where downtime or drift results in lost animals and lost data.

Beyond raw specifications, the ophthalmic laser system must provide sufficient documented design validation to demonstrate shot-to-shot stability, clean plasma formation, and reduced optical breakdown variability. In practice, this translates to:

• More predictable tissue response at lower energy

• Reduced need for repeated shots

• Lower cumulative energy delivered to the eye

Platforms used in similar settings which have demonstrated a tendency toward calibration drift and variability are not technically acceptable as this calibration drift and variability are particularly problematic in research environments where precision and reproducibly are required to support result validity. For example, in large-animal studies, a system going out of calibration does not merely delay work; it can invalidate entire experimental cohorts.

The reliability and stability standards, as described are anticipated to directly support experimental reproducibility, improve animal welfare, and contribute to cost control.

6. Parameter flexibility across multiple axes (offset, energy, burst structure) to support exploratory and iterative surgical technique development.

7. A laser stand/table is required, and it must be mobile and wheelchair-accessible.

Services to be performed The vendor will provide the following services to NEI, OGVFB, TRC:

- Delivery of a Combined YAG / SLT ophthalmic laser system and mobile wheelchair-accessible laser stand/table.

- Professional on-site installation and system calibration, performed by certified technical staff.

- Initial system orientation and user training, including instruction for safe operation, emergency shut-down procedures, and basic troubleshooting.

Place of Performance ☐ Work will be performed at contractor’s site.

☑ Work will be performed at NIH on-campus location:

Building 49, NIH Main Campus

9000 Rockville Pike

Bethesda, MD 20892

Period of Performance Vendor shall complete delivery and setup within 60 business days of receiving a Purchase Order.

Vendor shall perform installation and training on the same day of delivery or within 5 business days thereafter.

Expected Deliverables Dual YAG/SLT ophthalmic laser system which aligns with the minimum technical requirements as documented. Vendor will certify installation completion and provide documentation of system readiness for use.