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Friday / September 25.
HomeminewsPositive Multicenter Study for Molteno3 Glaucoma Drainage Device

Positive Multicenter Study for Molteno3 Glaucoma Drainage Device

Findings from a retrospective, nonrandomised, noninferiority multicentre study have reinforced the surgical utility of the Molteno3 glaucoma drainage device, as compared to the Baerveldt (Johnson & Johnson).

Published in Ophthalmology, the study by Dr Arsham Sheybani and colleagues reported the surgical time of the Molteno3 SS-185 to be 15.7 minutes faster than the Baerveldt BG-101-350.

According to Mr. Joe Bankovich, President of distributor Nova Eye Medical, the Molteno3 is a game-changer for glaucoma surgeons, saving valuable time in the operating room while also delivering on clinical efficacy.

Findings from a retrospective, nonrandomised, noninferiority multicentre study have reinforced the surgical utility of the Molteno3 glaucoma drainage device

“The smaller plate of the Molteno3, which occupies approximately 40% less scleral real estate than the Baerveldt,* makes it quicker to implant by an average of 15 minutes.* This optimises the utilization of operating room resources,” he said.

Clinical outcomes for the Molteno3 were also favourable. Despite the smaller surgical plate of the Molteno3, intraocular pressure (IOP) reduction was within target range for the Molteno3 at the 24-month follow-up at 16.6 mmHg, compared to the Baerveldt at 17.0 mmHg.

“Historically, there has been a perception that a larger plate is needed in order to achieve long-term IOP reduction. The study by Dr. Sheybani and colleagues validates an extensive body of clinical work that supports the clinical efficacy of the Molteno3,” said Mr Bankovich.

“The Molteno3 has been designed with a smaller plate and unique geometry, including a patented Primary Drainage Area, to achieve the same efficacy outcomes as larger plates but with the benefits of a simplified and shorter surgical procedure.”

The overall rates of failure were 27.5% for the Molteno3 compared to 45.5% for the Baerveldt. Further, 100% of the Molteno3 glaucoma drainage devices were implanted by residents or fellows. According to Mr Bankovich, this is testament to the simplified surgical technique of the Molteno3, in which the small plate size of 185mm2 eliminates the need to manipulate the extraocular muscles during implantation.

“The Molteno3 is the culmination of more than 50 years’ of research into glaucoma drainage surgery and represents one of the latest innovations in glaucoma implant technology. Despite offering enhanced surgical utility and optimised clinical outcomes, the Molteno3 has yet to find its rightful place at the top of the market. With the compelling results from this recent study, combined with our glaucoma-focused sales, marketing and clinical infrastructure, we look forward to growing the Molteno3 physician base in the USA and globally,” said Mr Bankovich.

The publication of the study coincides with the completion of Nova Eye Medical’s acquisition of the Molteno3 ophthalmology assets from Molteno Ophthalmic Limited.

About the Study

The study was a retrospective, nonrandomised, multicenter comparative study comprising 117 eyes that underwent implantation of the Baerveldt (n = 77) or the Molteno3 (n=40) glaucoma drainage device. Follow-up period was 24 months or greater.

A noninferiority study design provided robust evaluation of similarity between the devices, as opposed to nonsignificant P value from standard/superiority testing where nonsignificance may emerge from low statistical power due to small sample size and/or high variance versus a true lack of difference.

The primary outcome measure was the rate of failure, defined as IOP > 21 mmHg or a decrease <20% on two consecutive visits at 3-month follow-up, IOP </ 5 mmHg on two consecutive visits after three-month follow-up, removal of device, loss of light perception vision, or reoperations for failure.

  1. The overall rate of failure for the Baerveldt was 45.5%
  2. The overall rate of failure for the Molteno3 was 27.5%

Secondary outcome measures included intraoperative time, mean post-op IOP, number of medications and VA.

Intraoperative Time:

  1. The surgical time of the Molteno3 SS-185 as compared to the Baerveldt BG-101-350 was 15.7 minutes faster.
  2. The surgical time of the Molteno3 SS-185 as compared to the Baerveldt BG-103-250 was 4.3 minutes faster.

Mean IOP:

  1. With the Molteno3, IOP reduced from 22.8 mmHg at baseline to 16.6mmHg.
  2. With the Baerveldt, IOP reduced from 23.6 mmHg at baseline to 17.0mmHg.

Mean Number of Medications:

  1. With the Molteno3, the number of medications fell from 3.3 ± 0.8 at baseline to 2.0 ± 1.43.
  2. With the Baerveldt, the number of medications fell from 3.4 ± 1.0 at baseline to 2.1 ± 1.41.

Click here to access the study.

Footnote

* Molteno3 SS-185 compared to the Baerveldt BG-101-350. Molteno3 SS-185 = 185 mm2 plate size/ Baerveldt BG-101-350 = 350 mm2 plate size

Reference

Dixon MW, Moulin TA, Margolis MS, et al. Comparative Outcomes of the Molteno3 and Baerveldt Glaucoma Implants. Ophthalmol Glaucoma. 2020;3(1):40-50.

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