Early data suggests novel polymer-based microshunt is safe in refractory childhood glaucoma
A novel polymer-based microshunt currently under review by the US Food & Drug Administration (FDA) for use in adults appears to be safe and effective in refractory childhood glaucoma, according to a study. This device may provide a potential alternative to current refractory childhood glaucoma treatment options, which include trabeculectomy or large glaucoma drainage devices (GDDs).
Under the FDA compassionate-use Investigational Device Exemption, singles eyes of 12 children with refractory childhood glaucoma were treated surgically with the microshunt in this prospective single-center case series.
The children had a mean preoperative IOP 22.72±4.8 mmHg and were on 3.3±0.65 medications. There were no intraoperative complications.
Nine eyes with ≥1 year of follow-up were successfully controlled; this group had a 45% drop in IOP from 21.6±4.9 mmHg preoperatively to 11.9±3.8 mmHg at 1 year. At 12 months, 7 of these eyes required no medications and 2 required 2 medications (fixed-combination dorzolamide-timolol). Additional surgery was required in 3 eyes.
Brandt JD. Use of a Novel Microshunt in Refractory Childhood Glaucoma Initial experience in a Compassionate Use / Early Access Cohort. Am J Ophthalmol. 2022;S0002-9394(22)00128-3. doi: 10.1016/j.ajo.2022.03.021. Epub ahead of print. PMID: 35346624.