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Safety evaluation of BSS plus in pediatric intraocular surgery
Insights
BSS Plus, a new ophthalmic irrigating solution, was evaluated for safety in pediatric eye surgeries. The study found the solution safe for use in pediatric ophthalmic procedures.
Area of Science:
- Ophthalmology
- Surgical Innovation
- Pediatric Medicine
Background:
- Intraocular irrigating solutions are crucial for maintaining ocular tissues during surgery.
- BSS Plus is a modified glutathione-bicarbonate-Ringer's solution designed to support cellular integrity.
- Pediatric ophthalmic surgery presents unique challenges requiring specialized solutions.
Purpose of the Study:
- To assess the safety and tolerability of BSS Plus in pediatric patients undergoing ophthalmic surgery.
- To evaluate the efficacy of BSS Plus as a perfusate in maintaining ocular health during procedures.
Main Methods:
- An open-label, multi-center study involving 30 pediatric patients.
- Patients underwent lens aspiration or anterior segment reconstruction with vitrectomy instrumentation.
- BSS Plus was used as the intraocular irrigating solution during the procedures.
Main Results:
- Transient postoperative increases in intraocular pressure were observed.
- Temporary ocular inflammatory signs consistent with surgical trauma were noted.
- No adverse events directly attributable to BSS Plus were reported.
Conclusions:
- BSS Plus was determined to be safe for use in pediatric ophthalmic surgery.
- The observed transient effects were consistent with surgical trauma, not the irrigating solution.
- BSS Plus is a viable option for intraocular irrigation in pediatric cases.
Abstract:
An open-label study was conducted to determine the safety of a new intraocular irrigating solution, BSS Plus, when used during pediatric ophthalmic surgery. BBS Plus is a modified glutathione-bicarbonate-Ringer's solution which contains the necessary ions, buffers, and substrates for maintenance of normal cellular metabolism, function, and structural integrity when used as a perfusate during ophthalmic surgical procedures. At three centers, 30 patients undergoing lens aspiration or anterior segment reconstruction using vitrectomy instrumentation were enrolled in this study. Transient postoperative increases in intracellular pressure and internal or external ocular inflammatory signs were seen which were consistent with the trauma produced by the surgical procedure. The solution was judged to be safe when used in these surgical indications.