Preclinical Safety Evaluation of Ophthalmic Viscosurgical Devices in Rabbits and a Novel Mini-Pig Model
Bibliographic record
Abstract
INTRODUCTION: To establish the preclinical safety and equivalency of ophthalmic viscosurgical devices (OVDs) comprised of bacterially sourced sodium hyaluronate (HA) to animal sourced HA using pyrogenicity and aqueous exchange models in rabbits and a novel mini-pig model to evaluate corneal endothelial cell protection in vivo. METHODS: HEALON OVD and HEALON5 OVD containing animal-derived HA and HEALON PRO OVD and HEALON5 PRO OVD containing bacterial-derived HA were used. Two rabbit aqueous exchange studies were conducted where aqueous humor was exchanged with OVDs in six animals each to observe potential ocular inflammation, intraocular pressure (IOP) response, corneal health and pachymetry until 7 days post procedure, as well as overall assessment of the OVDs. Endothelial cell protection was evaluated in a Yucatan mini-pig cataract surgery model where HEALON PRO and HEALON5 PRO OVDs were compared to HEALON and HEALON5 OVDs, respectively. Following cataract surgery with use of OVDs in six animals per study, animals were evaluated for ocular and general health, IOP, corneal thickness, ocular inflammation, and endothelial cell protection on days 1, 3, 7 and 14 post-surgery. RESULTS: All rabbit studies demonstrated equivalence between bacterial-derived and animal-derived OVDs. Mild, post-surgical irritation, IOP increase, and corneal thickness measurements were not significantly different in HEALON PRO OVD and HEALON5 PRO OVD compared to HEALON and HEALON5 OVDs, respectively. The mini-pig model developed to investigate endothelial cell protection was successful in demonstrating equivalence between the OVDs studied. Changes in IOP mirrored actual surgical procedures, while corneal pachymetry and endothelial cell density remained constant for all OVDs used. Slit lamp observations showed expected inflammation following surgical procedures, likely due to challenges encountered during surgical procedures. CONCLUSION: Rabbit pyrogenicity and aqueous exchanged paired with a novel simulated cataract surgery mini-pig model demonstrate equivalence of OVDs regardless of HA source. Albeit with challenges, the mini-pig model was shown to be a promising tool for endothelial cell evaluation during the development of new OVDs for ophthalmic use. FUNDING: Johnson & Johnson Surgical Vision, Inc.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".