Molteno

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The Molteno™ Glaucoma Drainage Device was Dr. Molteno's 1st generation solution to complex cases of glaucoma.  Recently, the enhanced Molteno3, a more technologically advanced version, has been reengineered based on the advice and input from top ophthalmic surgeons.

 

Indications

Molteno™ and Molteno3™ Implants are used to reduce the intraocular pressure in severe and complex cases of glaucoma where conventional drainage procedures have failed or offer little prospect of success. The surgeon must weigh up the risks and benefits in each case.

 

Indications include:

  • Failure of previous drainage.
  • Glaucoma associated with aphakia, trauma and uveitis.
  • Neovascular glaucoma.
  • Infantile and juvenile glaucoma including cases associated with Sturge-Weber syndrome and neurofibromatosis.
  • Adrenal primary glaucoma.

 

Contraindications

  • Intraocular infection. Molteno™ and Molteno3™ Implants SHOULD NOT BE USED in patients with an intraocular infection.
  • Rheumatoid arthritis, scleritis and immune corneal melt syndromes. In these conditions there is a strong tendency for the tissues in the vicinity of the implant to erode. This may result in extrusion of the implant and loss of the eye.
  • Scleral Buckle. The placement of a Molteno™ or Molteno3™ Implant may interfere with the subsequent surgical treatment of detachment of the retina.

 

Features and Benefits

  • Long-term biocompatibility is established.
  • Provides a robust and durable drainage system.
  • Preplaced suture holes ensure correct positioning on the globe.
  • Pressure Ridge Molteno® Implants have a subsidiary ridge which, when covered by Tenon's tissue, acts as a Pressure sensitive 'biological valve', limiting postoperative hypotony.
  • The range of implants allows the surgeon to choose the drainage area according to the severity of the glaucoma.
  • Double Plate Molteno® Implants have twice the drainage area of Single Plate Molteno® Implants. The twin plate design gives a large drainage area while avoiding interference with the extraocular muscles.
  • Choice of left or right eye configurations.
  • Insertion is well described and straightforward.
  • The surgeon may select from a variety of ligature or stent procedures to improve the control of postoperative hypotony and bleb fibrosis.

 

Additional Benefits

Molteno® Single Plate Implant

  • Indicated for elderly patients with reduced ciliary body function and for combined cataract and glaucoma operations.
  • Maximum drainage area: 265 mm2
  • PressureRidge™ Single Plate Molteno® Implant
  • Indicated for neovascular glaucomas, acute glaucomas in patients with reduced ciliary body function, elderly patients and combined cataract and glaucoma procedures.
  • Maximum drainage area: 265 mm2
  • Microphthalmic Plate Molteno® Implant
  • Mini version of the Single Plate Molteno® Implant with a reduced radius of curvature suitable for microphthalmic eyes.
  • 8mm plate diameter
  • Molteno® Double Plate Implants
  • Indicated for very severe glaucomas, younger patients with good ciliary body function and glaucomas associated with uveitis and retinal detachment.
  • Maximum drainage area: 530 mm2
  • Available in left eye (L2) and right eye (R2) configurations.

Pressure Ridge Double Plate Molteno® Implants

  • Combines the large drainage area of the Double PlateImplant with the subsidiary ridge for controlling postoperative hypotony.
  • Maximum drainage area: 530 mm2
  • Available in left eye (DL2) and right eye (DR2) configurations.

 

Technical Data

Molteno® Implants were developed for the treatment of severe and complex cases of glaucoma. The implants consist of a fine bore silicone tube opening onto the upper surface of one or more episcleral plates. The function of the tube is to deliver aqueous from within the eye onto the upper surface of the episcleral plate. The episcleral plate is firmly sutured to the sclera and covered by a thick flap of Tenon's tissue and conjunctiva. The function of the plate is to initiate the formation of a large circular bleb which develops a specialised fibrovascular bleb lining and becomes distended by aqueous. It is this fibrovascular bleb lining which is responsible for regulating the escape of aqueous from the eye and which determines the final level of intraocular pressure (IOP) that is achieved after insertion of the implant.

 

Implant Specifications:

Ridge to Ridge Diameter of Plate: 11.50 mm

External Plate Diameter: 13.00 mm

Maximum Plate Thickness: 1.65 mm

Tube Internal Diameter: 0.34 mm

Tube External Diameter: 0.64 mm

Translibimal Tube Length: 25.00 mm

Ordering

 

Surgical Techniques

Delayed Drainage

Drainage of aqueous may be delayed by tying an absorbable suture such as 5.0 Vicryl, the ‘Vicryl-tie”, around the translimbal tube of the implant close to the plate. This allows time for the formation of a thin bleb lining, the ‘preformed bleb’, in the tissues around the plate. When the Vicryl-tie dissolves 4 to 5 weeks after operation the tube opens and aqueous drains into the ‘preformed bleb’ effectively preventing post-drainage hypotony. During this time the IOP is controlled by hypotensive medication supplemented, if necessary, by making a relieving slit in the side of the translimbal tube the ‘Sherwood slit’. This slit acts as a safety valve and releases aqueous if the IOP rises above normal levels. It ceases to function about 4 weeks after operation around the time the Vicryl-tie dissolves.

Immediate Drainage

Immediate drainage may be preferable where the eye is actutely inflamed and when immediate reduction of IOP is required. Examples include acute neovascular glaucoma or glaucoma associated with uveitis. Use of a Pressure Ridge Molteno™ Implant in such cases reduces the risk of postoperative hypotony.

 

Warnings

A high level of surgical skill is necessary for the insertion of Molteno™ and Molteno3™ Implants. The surgeon should have observed and assisted with several previous implantation procedures and successfully completed one or more courses on Molteno™ Implant surgery prior to undertaking the treatment of glaucoma with Molteno™ or Molteno3™ Implants.

Prior to surgery the surgeon must inform any prospective patients, or their representative, of the possible complications associated with the use of Molteno™ or Molteno3™ Implants.

Hypotensive medication after Molteno™ Implant surgery

When the IOP is kept within normal limits there is a thinning of the bleb lining with a gradual and progressive fall in IOP. If the IOP is well controlled after Molteno™ / Molteno3™ Implant surgery (by hypotensive agents if necessary), there is a long term tendency for the IOP to fall and the need for hypotensive medication to decrease. On average, about 50% of cases need some hypotensive medication in the first year after Molteno™ / Molteno3™ Implant surgery. This proportion falls progressively to less than 20% after 5 years. Carbonic anhydrase inhibitors, beta-blockers and adrenergic agents are highly effective hypotensive agents after Molteno™ Implant surgery.

CAUTION: Miotics, prostaglandin analogues and other local vasodilating agents may cause elevation of IOP after implant surgery and should be avoided.

 

Precautions

  • DO NOT soak the implant in any solution other than a sterile balanced salt solution or strile normal saline.
  • AVOID chemical contamination.
  • DO NOT store the implant at a temperature greater than 110 F (44 C).
  • HANDLE THE IMPLANT CAREFULLY. Rough or excessive handling may damage the implant.

 

Complications

As with any surgical procedure there are risks involved. Potential complications accompanying Molteno™ Implant surgery may include, but are not limited to the following:

  • Choroidal detachment.
  • Retinal detachment.
  • Expulsive hemorrhage.
  • Pupillary block.
  • Lenticulo-ciliary block.
  • Shallowing and flattening of the anterior chamber.
  • Intraocular infection.
  • Diplopia.
  • Loss of central vision.
  • Hypotony.
  • Corneal endothelial damage.

 

Adverse reactions

Molteno™ and Molteno3™ Implants are commonly used in patients with pre-existing ocular pathology, in many cases associated with general disease e.g. diabetes. Adverse reactions have been observed and include:

  • Corneal endothelial damage when the tube touches the corneal endothelium.
  • Breakdown of the tissues overlying the bleb.
  • Diplopia when the placement of the implant interferes with the action of the extraocular muscles.
  • Corneal decomposition.
  • Cystoid macula oedema.
  • Retinal detachment.
  • Intraocular infection.

Utilization and Implantation

The Molteno™ and Molteno3™ Ophthalmic Ltd, Molteno3™ Implants are supplied STERILE in a dry heat sealed package. The inner package is sterilized with moist heat and should be opened under sterile conditions only.

When properly stored, the contents of the pouch are sterile for five years after the sterilization date, unless the package is damaged or opened.

Before using the implant, open the box and inspect the implant, checking that it is of the correct type and that it is not damaged. Handle the implant carefully. Rough or excessive handling may damage the implant.

A variety of surgical techniques may be employed during the placement of a Molteno3™ Implant. The surgeon is best advised to use the methods that his training and judgment dictate to be best for the patient.

The implant package contains peelable labels that display the implant type and serial number, etc. These labels are for convenience in maintaining records and reporting results. They are designed to be affixed to the patient’s hospital chart, the physician’s card and the return card.

Reporting

  • Adverse reactions and, or sight threatening complications that may reasonably be regarded as implant related or were unexpected should be reported to your distributor.
  • Surgeons are encouraged to report such events in order to identify any emerging problems and to document the long-term effect of Molteno™ and Molteno3™ Implants.
  • Contact your distributor for the proper forms to report adverse reactions and, or sight threatening complications that may reasonably be regarded as implant related.

The relevance of the reimbursement codes depends on indications of use and geographic region.

Please use the hotline or email to determine what the guidelines are for your area.

IOP Reimbursement Hotline:    1.888.700.9005

IOP Reimbursement Email:      support@nmdhealthcare.com

Surgicial Guides

Not Available

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