Ophthalmology · Medical Literature
Comparison of Safety and Efficacy of Two Dispersive Hyaluronate OVDs Used in Cataract Surgery.
Abstract
To compare safety and efficacy of ophthalmic viscosurgical devices (OVDs) - OphteisBio 3.0 (Rayner) and Healon Endocoat (J&J Vision) in phacoemulsification cataract removal surgery. In this prospective subject/evaluator-masked post-market randomized study patients undergoing phacoemulsification were assigned to receive one of two hyaluronate-based OVDs - OphteisBio 3.0 and Healon Endocoat. The outcomes were the rate of intraocular pressure (IOP) spikes ≥ 30 mmHg at the 7-day postoperative visit, endothelial cell density changes, the surgeon acceptance rate, IOP change from baseline, rates of inflammation and rates of serious and/or device-related adverse events. The study included 293 eyes - 146 in the Ophteis group and 147 in the Healon group. No IOP spikes were noted at the 7-day postoperative visit with mean IOP of 14.5 mmHg for Ophteis group and 14.3 mmHg for the Healon group. The mean endothelial cell density loss after the surgery was 9.8% in the Ophteis group and 10.2% in the Healon group with no statistically significant difference between the two OVD groups (p = 0.6292). At the 7-day visit, anterior chamber flare was absent in 98% and 99% of eyes in the Ophteis and Healon group, respectively. 82% of eyes had no anterior chamber cells at 7-day visit in both groups. No adverse events were recorded during surgery and at 7-day follow up. No clinically relevant differences were found between the two OVDs. Ophteis 3.0 and Healon Endocoat have comparable results following phacoemulsification surgery.
Clinical relevance
In patients undergoing phacoemulsification cataract surgery, are OphteisBio 3.0 (Rayner) and Healon Endocoat (J&J Vision) equivalent in safety and efficacy, as measured by postoperative IOP spikes, endothelial cell density loss, anterior chamber inflammation, and surgeon acceptance? __SNAPSHOT__ {"studyDesign":"Prospective, subject/evaluator-masked, post-market randomized controlled trial","setting":"Not reported (country and institution type not specified in the abstract)","sampleSize":"n=293 eyes (OphteisBio 3.0: n=146; Healon Endocoat: n=147)","population":"Adult patients undergoing phacoemulsification cataract removal surgery; additional inclusion/exclusion criteria not reported in the abstract","intervention":"OphteisBio 3.0 (Rayner) — a dispersive hyaluronate-based ophthalmic viscosurgical device (OVD) used intraoperatively during phacoemulsification","comparator":"Healon Endocoat (J&J Vision) — a dispersive 3% sodium hyaluronate-based OVD used intraoperatively during phacoemulsification","primaryOutcome":"Rate of intraocular pressure (IOP) spikes ≥30 mmHg at the 7-day postoperative visit","followUp":"Minimum 7 days confirmed; longer follow-up duration not reported in the abstract","fundingSource":"Not reported in the abstract; note that one comparator (OphteisBio 3.0) is manufactured by Rayner, which may represent a potential conflict of interest — relationship between authors and manufacturers not disclosed in the abstract"}
Key findings
Primary outcome: No IOP spikes ≥30 mmHg were recorded at the 7-day postoperative visit in either group. Mean postoperative IOP was 14.5 mmHg in the OphteisBio group and 14.3 mmHg in the Healon group; no between-group p-value or confidence interval for IOP difference was reported. Endothelial cell density (ECD) loss was 9.8% in the OphteisBio group and 10.2% in the Healon group, with no statistically significant difference (p=0.6292); absolute difference was 0.4 percentage points (calculated). NNT/NNH cannot be calculated for continuous or non-event outcomes such as ECD loss. Anterior chamber flare was absent in 98% of eyes at the 7-day visit (group-level breakdown not reported in the abstract). Surgeon acceptance rate, rates of serious and/or device-related adverse events, and full inflammation data were not reported in the abstract. No p-value, confidence interval, or effect size was provided for the primary IOP spike outcome, as zero events occurred in both arms, precluding formal comparative statistical testing.
Practice implications
This study found no IOP spikes ≥30 mmHg at 7 days postoperatively with either OVD and found statistically equivalent endothelial cell density loss between the two dispersive hyaluronate OVDs (p=0.6292). These findings suggest that OphteisBio 3.0 is broadly comparable to the reference-standard Healon Endocoat across the reported safety parameters. However, several important limitations constrain interpretation: (1) Only an abstract is available; full data including adverse events, confidence intervals for all outcomes, surgeon acceptance rates, and inflammation sub-group analyses are not yet accessible. (2) The absence of IOP spikes at day 7 is reassuring but the critical early IOP spike window is the first 6–24 hours postoperatively, which is not reported here. (3) ECD loss of approximately 9–10% is within the range typically expected with phacoemulsification and dispersive OVDs, but without longer follow-up (3–6 months), the durability of ECD protection cannot be assessed. (4) The study was conducted in a relatively narrow surgical population; applicability to patients with Fuchs endothelial dystrophy, pseudoexfoliation, or compromised endothelium is not established. (5) Industry sponsorship status is unknown, and potential conflicts of interest are not disclosed in the abstract. Overall, the data are consistent with non-inferiority but formal non-inferiority analysis and margins are not reported. Practice change is not warranted on this evidence alone; however, results support OphteisBio 3.0 as a plausible alternative to Healon Endocoat pending peer-reviewed full publication. __LIMITATIONS__ Only an abstract is available; full methods, pre-specified statistical analysis plan, non-inferiority margin, and complete adverse event data are not accessible for critical appraisal.,The primary outcome (IOP spike ≥30 mmHg at day 7) yielded zero events in both arms, preventing formal between-group statistical comparison and making the study effectively underpowered to detect rare IOP elevation differences.,The early postoperative period (first 6–24 hours), when dispersive OVD-related IOP spikes are most likely to occur, was not reported in the abstract.,Follow-up of 7 days is insufficient to evaluate endothelial cell density trajectories; standard OVD trials assess ECD at 3–6 months postoperatively.,Blinding was subject/evaluator-masked but the abstract does not confirm surgeon masking, which could introduce performance bias.,Patient selection criteria, comorbidities (e.g., glaucoma, Fuchs dystrophy, pseudoexfoliation), and surgical complexity are not reported, limiting generalizability.,Funding source and author conflicts of interest are not disclosed in the abstract, and the study is characterized as a 'post-market' study, which may introduce industry-related bias.,The study unit is eyes (n=293), not patients; whether the same patient contributed both eyes is not clarified, which could violate independence assumptions in the analysis.,Surgeon acceptance rate and full inflammation data results are truncated in the abstract and cannot be evaluated.,The study was not powered or designed to detect differences in rare but serious adverse events (e.g., toxic anterior segment syndrome, persistent corneal decompensation). __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ OphteisBio 3.0 and Healon Endocoat demonstrated comparable postoperative IOP profiles (no spikes ≥30 mmHg at day 7) and statistically equivalent endothelial cell density loss (~9.8% vs. 10.2%; p=0.6292) in this 293-eye randomized post-market study. However, the 7-day follow-up is insufficient for definitive endothelial protection conclusions, the critical early IOP spike window was not assessed, and the full peer-reviewed publication is required before clinical adoption decisions are made. Surgeons may consider OphteisBio 3.0 a potentially comparable alternative to Healon Endocoat, but this remains a preliminary signal pending complete data disclosure.