Molteno3®

ACHIEVE CONSISTENT, LONG-TERM IOP CONTROL IN CASES OF SEVERE AND COMPLEX GLAUCOMA WITH THE MOLTENO3® GLAUCOMA DRAINAGE DEVICE

Implanted in thousands of patients worldwide, the Molteno3® Glaucoma Drainage Device has been clinically validated to deliver consistent, long-term reduction in intraocular pressure (IOP) in cases of severe or complex glaucoma. It has also been shown to offer the benefit of improved practice efficiency.

MOLTENO3® IS DESIGNED FOR CONSISTENT IOP REDUCTION

The Molteno3® has demonstrated consistent success rates in a range of severe and complex glaucoma patients, including POAG, PEXG, NVG and uveitic glaucoma.1

Over a three-year follow-up period, Molteno3® deployed as a primary surgical option achieved a high rate of success at 91%. Failure was defined as IOP >21, IOP reduction ≤ 5mmHg or IOP reduction <20% reduction at two consecutive visits after three months’ follow-up, reoperation for glaucoma or loss of light perception.

MOLTENO3® ACHIEVES CONSISTENT SUCCESS RATES

1 2 3 0 50 100 Time (year post surgery) Success 97% 94% 91%

MOLTENO3® IS DESIGNED TO ENHANCE CLINICAL OUTCOMES AND OPTIMIZE SURGICAL UTILITY

The novel design elements of the Molteno3® enable it to achieve the same clinical outcomes as larger plate alternatives via a shorter, simplified surgical procedure. With a contoured plate that measures just 185 mm2, the Molteno3® occupies less scleral real estate and requires less manipulation of the extraocular muscles.

POLYPROPYLENE PLATE

The smooth surface texture of the Molteno3® polypropylene plate may reduce the risk of immune responses that negatively affect the filtering bleb – and thus safeguard against bleb encapsulation.

SECONDARY DRAINAGE AREA

1. Forms thin, permeable bleb for long-term IOP control

CONTOURED PLATE

The contoured design of the Molteno3® plate is designed to hug the sclera without riding forward.

PATENTED PRIMARY DRAINAGE AREA

1. Facilitates staged bleb formation
2. Triggers early apoptosis
3. Reduce post-op hypotony in cases of immediate drainage

SUTURE HOLES

1. Anterior suture holes
2. Fast, easy implantation

DELAYED DRAINAGE

1. Delayed drainage with Vicryl® tie
2. Reduces post-op hypotony

SILICONE TUBE

1. Trans-limbal or pars plana insertion

MOLTENO3® FEATURESSMOOTH POLYPROPYLENE PLATE FOR REDUCED FIBROSIS

The smooth surface texture of the Molteno3® polypropylene plate may reduce the risk of immune responses that negatively affect the filtering bleb2 – and thus safeguard against bleb encapsulation.

In an evaluation of cell cultures in vitro by Hong et al, the Molteno3® demonstrated 20 times less fibroblast cell adhesion as compared to the Ahmed® FP7 plate (100 ±24 cells versus 5 ± 1 cells), and 3 times less fibroblast cell adhesion as compared to the Baerveldt® (15 ± 3 cells versus 5 ± 1 cells).2 These findings are corroborated in clinical practice, with the Molteno3® recording one of the industry’s lowest rates of bleb encapsulation at 20%.3

COMPARISON OF PLATE CHARACTERISTICS AND CELL ADHESION2

Molteno3® Ahmed® FP7 Baerveldt®
Plate material Polypropylene Silicone Silicone
Plate topography 0.07 microns 1.5 microns 0.1 microns
Cell adhesion 5 ±1 cells 100 ±24 cells 15 ±3 cells

SLIMLINE, CONTOURED MOLTENO3® PLATE SIMPLIFIES INSERTION

At just 0.4mm the Molteno3® is the slimmest plate on the market and slides easily between the tissue planes – there is no need to dissect muscles or to use muscle hooks during insertion. This slimline design may also reduce the risk of diplopia: the Molteno3® has one of the lowest reported rates of diplopia at 1%.7,8 As an added benefit, the contoured design of the Molteno3® plate is designed to hug the sclera without riding forward.

COMPARISON OF PLATE THICKNESS4,5,6

Molteno3® Ahmed® FP7 Ahmed Clearpath® Baerveldt®
0.4 mm 2.1 mm 0.86 mm 0.95 mm

The contoured design of the Molteno3® plate is crucial. Whereas some other GDDs will ride forward in the case of a short eye or a tight globe, or due to posterior forces, the Molteno3® hugs the sclera wall beautifully.

MOLTENO3® IS DESIGNED FOR FASTER IMPLANTATION

Ranging from 185 mm2 (SS model) to 245 mm2 (SL model), and with a slimline plate measuring 0.4mm, the Molteno3® S‑Series was shown to be up to 15 minutes faster to implant than larger plate alternatives in a recent prospective study by Sheybani and colleagues.9

One of the coolest things about the Molteno3® is its efficiency. It’s a true single quadrant surgery. There’s no muscle involvement and so you don’t have to worry about dissecting the muscles or using muscle hooks.

MOLTENO3® S‑SERIES

The Molteno3® is available in two models:

Molteno3® SS-185 Molteno3® SL-245
Plate area 185 mm² 245 mm²
Plate width x length 13.515 mm 1517 mm
Plate thickness 0.4 mm 0.4 mm
Versatile for use in for most cases, both pediatric and adult.  Used for cases requiring a large drainage area i.e., younger adults with good immune response, larger eyes and good ciliary body function. 

I tend to use the Molteno3® SS-185. It’s easy to handle. It’s also easy to fit into small orbits and small eyes and less dissection is needed.

MOLTENO3® IS DESIGNED TO CREATELIFELONG FUNCTIONING BLEB

The Molteno3® employs a two-stage process of bleb formation. Comprising delayed drainage and a proprietary Primary Drainage Area, the Molteno3® is designed to initiate a sequence of cellular changes that enhance bleb structure.

1. Delayed Drainage

Using a Vicryl® Tie, delayed drainage prevents the initial flow of aqueous from reaching the Molteno3® plate during the early stages of bleb formation and thus allows sufficient time for a thin layer of collagen to form around the plate. It also avoids exposure of the Molteno3® plate to inflammatory cells, cytokines, and proteins resulting from the surgery, thereby preventing the development of a thick layer of fibrosis in the early phases of bleb formation.

2. Primary Drainage Area

Once the Vicryl® tie dissolves, the flow of aqueous commences but is initially restricted to the Primary Drainage Area.

As more aqueous enters the Primary Drainage Area, there is an increase in pressure. The IOP continues to rise until it is higher than episcleral venous pressure. At this point, aqueous displaces extracellular fluid within the Primary Drainage Area and the cells are immersed in aqueous. This triggers a more intense, and early, process of apoptosis.

As the IOP increases the tissues lift off the rim of the Primary Drainage Area and aqueous infused with pro-apoptotic factors flows from the Primary Drainage Area to the Secondary Drainage Area.

A thin, permeable long-term bleb forms around the Secondary Drainage Area.

Stage 1
Aqueous is restricted to the Primary Drainage Area (A).

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Stage 2
Increase in IOP triggers aqueous to flow into Secondary Drainage Area (B).

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MOLTENO3® ACHIEVES SIMILAR EFFICACY TO TRABECULECTOMY

In a prospective case series of 718 eyes the Molteno3® achieved similar reduction in IOP and medication-use as compared to trabeculectomy at 10 and 20 years respectively.10

MOLTENO3® ACHIEVES SIMILAR RESULTS TO TRABECULECTOMY OVER THE LONG-TERM

Baseline 10 Years Mean IOP (mmHg) 23.8 mmHg 23.9 mmHg 14.9 mmHg 13.9 mmHg Molteno ® Trabeculectomy 20 Years 14.7mmHg 13.5 mmHg

1. Välimäki, J O et al. Molteno3 Implantation as Primary Glaucoma Surgery. J Ophthalmol. 2014; 2014167564.

2. Lars Choritz, et al. Surface Topographies of Glaucoma Drainage Devices and Their Influence on 

Human Tenon Fibroblast Adhesion. Investigative Ophthalmology & Visual Science, August 2010. 51, No. 8.

3. Hong C‑H, Arosemena A, Zurakowski D, Ayyala RS. Glaucoma drainage devices: A systematic literature review and current controversies. Surv. Ophthalmol 2005; 50:48 – 60

4. New World Medical website: https://​www​.new​worldmed​ical​.com/​w​p​-​c​o​n​t​e​n​t​/​u​p​l​o​a​d​s​/​2019​/​12​/​A​G​V​-​F​P​7​-​I​FU-50 – 0088.pdf. Accessed 27 March 2020.

5. New World Medical website: https://​www​.new​worldmed​ical​.com/​w​p​-​c​o​n​t​e​n​t​/​u​p​l​o​a​d​s​/​2019​/​12​/​C​l​e​a​r​P​a​t​h​_​I​FU-50 – 0109.pdf. Accessed 27 March 2020.

6. Johnson & Johnson website: https://​www​.jnjvi​sion​pro​.com/​p​r​o​d​u​c​t​s​/​b​a​e​r​veldt®-glaucoma-implants. Accessed 27 March 2020

7. Välimäki, J O et al. Molteno3 Implantation as Primary Glaucoma Surgery. J Ophthalmol. 2014; 2014167564.

8. Sun, PY et al. Diplopia in Medically and Surgically Treated Glaucoma Patients Ophthalmology. 2017 Feb; 124(2): 257 – 262.

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

10. Molteno ACB, et al. Long-Term Results of Primary Trabeculectomies and Molteno Implants for Primary Open-Angle Glaucoma. 2011. Arch Ophthalmol; 129(11):1444 – 1450

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