Surgical Technique 1 (Molteno Glaucoma Implant)


Summary

Results depend on the etiology of the glaucoma and previous ocular history. The Otago Glaucoma Surgery Outcome Study follows surgically treated cases of glaucoma at Dunedin Hospital, New Zealand. Long-term IOP control at 5 years (and 10 years if available) after single- or double-plate implant surgery ranges from 100% in primary glaucoma, through 87% (77%) in uveitic glaucoma, 85% (78%) in juvenile open-angle glaucoma, 80% (72%) in glaucoma secondary to trauma to 40% in neovascular glaucoma. Outcomes of trabeculectomy and single- and double-plate Molteno implants are shown in Tables 111-1 and 111-2 , IOP control by implants according to glaucoma etiology in Table 111-3 , and results of the Molteno3 implant in Table 111-4 .

Table 111-1
Status of Cases of Primary Open-Angle Glaucoma Treated by Trabeculectomy or Single- or Double-Plate Molteno Implants at Dunedin Hospital Between 1986 and 2003 as of January 2004
Number IOP Control (IOP 5–21 mmHg) Fail
No Medication With Medication
Trabeculectomy as first or subsequent operation * 531 366 (69%) 125 (24%) 40 (8%)
Implant as first operation or following trabeculectomy * 223 153 (69%) 70 (31%) 0
Trabeculectomy as first operation 510 357 (70%) 122 (24%) 32 (6%)
Implant as first operation 182 135 (74%) 47 (26%) 0
Trabeculectomy after failed trabeculectomy 21 10 (48%) 3 (14%) 8 (38%)
Implant after failed trabeculectomy 41 20 (49%) 21 (51%) 0
Phacotrabeculectomy 109 64 (59%) 38 (35%) 7 (6%)
Phaco/implant 51 39 (77%) 12 (24%) 0
Trabeculectomy and subsequent cataract extraction 122 74 (61%) 26 (21%) 22 (18%)
Implant and subsequent cataract extraction 48 34 (71%) 14 (29%) 0

* Includes cases in the respective subsets below.

Table 111-2
Mean IOP and Hypotensive Medication Use in Cases of Primary Open-Angle Glaucoma Treated by Trabeculectomy or Single- or Double-Plate Molteno Implants at Dunedin Hospital Between 1986 and 2003 as of January 2004
Number
Mean IOP (Standard Deviation) in mmHg
Mean Number of Hypotensive Medications
Preoperative Years Postoperative
1 2 5 10 15
Trabeculectomy as first or subsequent operation * n = 531 n = 445 n = 377 n = 224 n = 90 n = 14
23.7 (6.6) 15.0 (3.5) 15.0 (3.4) 14.9 (3.2) 15.4 (4.2) 14.5 (4.1)
1.90 0.23 0.29 0.42 0.45 0.96
Implant as first operation or following trabeculectomy * n = 223 n = 182 n = 160 n = 87 n = 27 n = 2
24.0 (6.5) 14.4 (2.9) 14.2 (3.2) 14.2 (3.1) 13.1 (3.3) 10.3 (0.4)
1.98 0.59 0.54 0.48 0.50 1.00
Trabeculectomy as first operation n = 510 n = 431 n = 365 n = 216 n = 87 n = 12
23.7 (6.5) 15.0 (3.5) 15.0 (3.3) 14.8 (3.1) 15.3 (4.3) 14.1 (4.3)
1.89 0.21 0.27 0.38 0.45 0.87
Implant as first operation n = 182 n = 147 n = 126 n = 63 n = 16
23.9 (6.6) 14.4 (2.8) 14.0 (2.8) 14.2 (2.9) 12.2 (2.5)
1.96 0.57 0.49 0.35 0.40
Trabeculectomy after failed trabeculectomy n = 21 n = 14 n = 11 n = 9 n = 5 n = 5
25.9 (8.7) 18.4 (4.7) 16.2 (5.4) 16.7 (4.7) 15.7 (1.0) 16.1 (2.4)
2.10 0.72 0.97 1.22 0.80 0.80
Implant after failed trabeculectomy n = 41 n = 35 n = 34 n = 24 n = 11 n = 2
24.6 (6.0) 14.7 (3.3) 14.8 (4.3) 14.4 (3.7) 14.3 (4.0) 10.3 (0.4)
2.07 0.73 0.72 0.81 0.66 1.00
Phacotrabeculectomy n = 109 n = 89 n = 64 n = 28 n = 6
21.0 (6.0) 16.2 (3.2) 16.2 (3.6) 15.2 (3.6) 19.5 (7.0)
1.66 0.3 0.42 0.57 0.85
Phaco/implant n = 51 n = 47 n = 38 n = 21 n = 11
21.7 (6.2) 14.0 (2.3) 13.5 (2.6) 13.1 (2.9) 12.0 (2.3)
1.87 0.51 0.48 0.52 0.36
Trabeculectomy and subsequent cataract extraction n = 122 n = 117 n = 115 n = 86 n = 47 n = 18
24.9 (5.6) 14.5 (3.7) 14.9 (3.8) 15.3 (3.1) 14.8 (3.4) 14.2 (3.2)
1.95 0.21 0.24 0.43 0.30 0.37
Implant and subsequent cataract extraction n = 48 n = 46 n = 43 n = 27 n = 8
23.8 (7.2) 14.8 (2.7) 14.6 (3.0) 14.6 (3.6) 14.9 (4.6)
1.75 0.48 0.39 0.52 0.68

* Includes cases in the respective subsets below.

Table 111-3
Mean IOP and Hypotensive Medication Use in Cases of Glaucoma According to Etiological Group Treated by Single- or Double-Plate Molteno Implants at Dunedin Hospital Between 1977 and 2003
Number
Mean IOP (Standard Deviation) in mmHg
Mean Number of Hypotensive Medications
Glaucoma Etiology Preoperative Years Postoperative
1 2 5 10 15 20
Primary open angle n = 279 n = 279 n = 245 n = 168 n = 65 n = 18 n = 2
24.2 (6.6) 15.7 (3.9) 14.9 (3.5) 14.4 (3.5) 14.4 (3.8) 13.2 (3.7) 13.8 (1.1)
2.11 1.15 0.65 0.57 0.62 0.84 1.50
Neovascular n = 148 n = 100 n = 75 n = 29 n = 9 n = 2
40.0 (12.8) 19.6 (9.3) 19.1 (10.0) 21.9 (11.0) 26.8 (10.7) 12.0 (5.7)
1.30 0.77 0.72 0.78 0.52 0.25
Secondary n = 74 n = 65 n = 60 n = 37 n = 21 n = 13 n = 3
31.2 (10.9) 16.4 (5.5) 15.9 (5.5) 17.4 (7.6) 16.5 (4.1) 18.6 (6.9) 18.8 (13.3)
2.02 0.68 0.53 0.65 0.50 0.98 0.16
Buphthalmos n = 49 n = 43 n = 42 n = 36 n = 27 n = 19 n = 8
32.9 (12.5) 15.0 (4.3) 15.2 (4.4) 15.5 (4.1) 16.6 (3.5) 17.3 (3.7) 16.7 (3.0)
1.67 0.40 0.38 0.39 0.68 0.76 0.87
Uveitic n = 49 m = 43 n = 39 n = 29 n = 17 n = 7 n = 3
31.4 (13.4) 15.9 (5.2) 15.5 (6.1) 14.8 (4.4) 15.4 (4.6) 13.4 (5.5) 10.5 (4.9)
1.87 0.58 0.46 0.52 0.47 0.14 0.33
Traumatic n = 43 n = 35 n = 34 n = 29 n = 19 n = 12 n = 9
32.7 (13.6) 15.9 (3.3) 15.4 (3.9) 15.5 (3.5) 15.0 (4.4) 15.4 (3.8) 13.8 (4.4)
1.86 0.44 0.31 0.36 0.14 0.08 0.33
Juvenile n = 24 n = 20 n = 19 n = 18 n = 13 n = 9 n = 4
27.8 (9.7) 17.1 (4.8) 17.1 (4.7) 16.3 (4.3) 16.2 (2.6) 18.4 (8.8) 16.3 (1.5)
2.00 0.81 0.58 0.77 0.99 1.11 1.07
Angle closure n = 21 n = 21 n = 21 n = 14 n = 6 n = 1
29.3 (12.0) 16.9 (4.6) 15.5 (3.9) 14.7 (3.6) 16.0 (2.7) 14.0
2.04 1.40 0.64 0.66 0.45 0

Table 111-4
Mean IOP and Hypotensive Medication use with Molteno3 Implants from 2004 to 2010 and Single- and Double-Plate Implants from 1986 to 2003 at Dunedin Hospital
Implant Number
Mean IOP (Standard Deviation) in mmHg
Mean Number of Hypotensive Medications
Preoperative Years Postoperative
Glaucoma Etiology n (%) 1 2 3
Molteno3 *
Primary open angle 148 (60%)
Neovascular 37 (15%)
Uveitic 12 (5%) n = 245 n = 245 n = 208 n = 166
Traumatic 10 (4%) 27.2 (10.5) 16.2 (5.1) 15.1 (5.2) 15.0 (5.7)
Secondary 22 (9%) 2.20 1.37 1.35 1.31
Angle closure 12 (5%)
Juvenile 4 (2%)
Molteno3 (175 mm 2 )
Primary open angle 139 (65%)
Neovascular 24 (11%)
Uveitic 10 (5%) n = 215 n = 215 n = 185 n = 147
Traumatic 8 (4%) 26.2 (9.8) 16.2 (5.1) 14.9 (4.9) 14.6 (5.4)
Secondary 19 (9%) 2.19 1.37 1.34 1.30
Angle closure 12 (6%)
Juvenile 3 (1%)
Molteno3 (230 mm 2 )
Primary open angle 9 (30%)
Neovascular 13 (43%)
Uveitic 2 (7%) n = 30 n = 30 n = 23 n = 20
Traumatic 2 (7%) 34.3 (12.9) 16.0 (5.2) 17.2 (7.4) 18.2 (6.8)
Secondary 3 (10%) 2.20 1.44 1.37 1.35
Angle closure 0
Juvenile 1 (3%)
Single-Plate
Primary open angle 81 (37%)
Neovascular 86 (40%)
Uveitic 5 (2%) n = 217 n = 217 n = 179 n = 159
Traumatic 3 (1%) 31.4 (13.2) 16.8 (4.9) 16.7 (6.9) 15.7 (6.8)
Secondary 16 (7%) 1.82 1.38 0.98 0.87
Angle closure 9 (4%)
Juvenile 17 (8%)
Double-Plate
Primary open angle 147 (52%)
Neovascular 32 (11%)
Uveitic 31 (11%) n = 283 n = 283 n = 244 n = 231
Traumatic 18 (6%) 28.5 (10.3) 16.3 (4.6) 15.3 (4.8) 15.2 (4.7)
Secondary 15 (5%) 2.23 1.38 0.85 0.76
Angle closure 9 (3%)
Juvenile 31 (11%)

* Includes Molteno3 subsets below.

Introduction

Molteno implants (Molteno Ophthalmic Limited, Dunedin, New Zealand) are surgical devices used in the treatment of severe and complex cases of glaucoma. They were developed by Anthony C.B. Molteno and consist of a fine-bore silicone tube that delivers aqueous from within the eye onto the surface of an episcleral plate ( Fig. 111-1 ). The plate is covered by Tenon's fascia and conjunctiva, and initiates and maintains a large circular unilocular bleb. The bleb develops a specialized fibrovascular lining called the bleb capsule that becomes distended by aqueous. The bleb capsule is responsible for regulating aqueous escape from the eye and is the main determinant of the final intraocular pressure (IOP) achieved by the draining implant.

Figure 111-1, Molteno implants, profile and top views. (A) Pressure ridge single-plate. (B) Pressure ridge double-plate, right eye. (C) Pressure ridge double-plate, left eye. (D) Molteno3 (area 175 mm 2 ).

Historical Background

Bleb Formation

Molteno implants were initially inserted at a single operation with immediate aqueous drainage into the tissues overlying the plate. This resulted in an early brief period of hypotony followed by a temporary hypertensive stage before long-term IOP stabilization was achieved ( Fig. 111-2 ). Bleb capsule permeability depended mainly on patient age and, to a lesser degree, glaucoma severity. Whilst infants aged less than 18 months and the frail elderly formed thin-walled blebs that drained well, older children and fit adults formed heavily fibrosed thick-walled bleb capsules that were incapable of adequately lowering the IOP.

Figure 111-2, IOP after Molteno implant surgery with immediate aqueous drainage in a 47-year-old male with advanced traumatic glaucoma. Note the hypotensive, hypertensive and late stable stages.

Research from the Otago Glaucoma Surgery Outcome Study indicates that a balance between cellular activation and apoptosis regulates the thickness and permeability of bleb capsules, and the normal life-cycle of bleb capsules includes continual inner surface degeneration and external surface renewal ( Fig. 111-3 ).

Figure 111-3, Cellular processes underlying the long-term equilibrium occurring in a bleb capsule from 6 weeks after operation.

Hypotensive, Hypertensive, and Stable Stages

The changes that accompany bleb formation around an implant are most obvious when a single-plate implant is used to drain severe and advanced glaucoma in a young adult. Three sequential stages are described according to the behavior of the IOP after implant insertion ( Fig. 111-2 ).

  • 1.

    Hypotensive stage : This stage lasts 7–10 days after operation and is characterized by low IOP with diffuse edema and congestion of blood vessels in the tissues covering the episcleral plate of the implant.

  • 2.

    Hypertensive stage : This stage is characterized by elevated IOP that peaks at 30–50 mmHg 4–5 weeks after operation (in untreated cases). As the edema subsides, a definite layer of fibrous tissue appears in the deepest layers of the bleb capsule and the bleb becomes distended with aqueous. However, it is not until the vascular congestion resolves that the IOP starts to fall, initially rapidly then more gradually, to reach a stable plateau 3–6 months after operation.

  • 3.

    Stable stage : Characterized by a stable IOP and well-circumscribed bleb with a moderately vascular fibrous bleb capsule, the stable-stage bleb remains unchanged for the remainder of the patient's life. The thickness of the capsule depends on the intensity and duration of bleb inflammation during the hypertensive stage. Trials of anti-inflammatory fibrosis suppression therapy were undertaken in an effort to limit inflammation and produce a thin permeable bleb capsule.

Control of Fibrosis

Delayed Drainage of Aqueous.

Delayed drainage of aqueous is used to control bleb fibrosis and was initially achieved by the two separate operation technique. In the first-stage operation, the plate of the implant was sutured to sclera and, instead of inserting the tube into the anterior chamber, the tube was tucked under a rectus muscle. Six to 8 weeks later, when the plate of the implant had become enclosed in a thin envelope of dense connective tissue, the free end of the tube was removed from beneath the muscle and inserted into the anterior chamber under a watertight scleral flap. This technique allowed the drainage area to be increased by linking 2–4 plates together in series. A clinical trial showed that four plates produced prolonged hypotony and suggested that the best compromise between avoidance of postoperative hypotony and good long-term IOP control was a double-plate implant (274 mm 2 ).

Since 1986, the two separate operation technique has been replaced by the Vicryl tie technique. In this operation, the implant plate is sutured to sclera and then covered by Tenon's fascia. The tube is firmly tied and occluded by 5/0 Vicryl and then inserted into the anterior chamber via a self-sealing puncture wound. Thus, the IOP remains at its preoperative level until the tube spontaneously opens 3–5 weeks after operation. When the Vicryl tie dissolves, aqueous drains into a preformed bleb capsule lined by a thin layer of fibrous tissue 20–60 µm thick.

The intensity of inflammation and subsequent hypertensive phase depend on patient age and glaucoma severity. In infants aged less than 18 months and frail elderly patients without severe glaucoma, tube opening is followed by up to 3 weeks of low-normal IOP (10–15 mmHg) and then 3–4 weeks of moderately elevated IOP (25–30 mmHg). Subsequently, the IOP falls to normal levels ( Fig. 111-4 ). In severe glaucoma and young patients, the same sequence occurs except that the IOP rises sooner to 35–40 mmHg and the bleb vessels become visibly dilated. In these high-risk patients, this hypertensive phase can be suppressed by anti-inflammatory fibrosis suppression therapy and the occasional addition of hypotensive medication. The bleb then becomes pale and the IOP falls to normal levels.

Figure 111-4, Depiction of IOP curves following Molteno implant insertion with the Vicryl tie technique for delayed aqueous drainage. Postoperative hypotensive medications help reduce the intensity of the hypertensive stage of bleb inflammation that occurs after aqueous drainage begins. This results in an overall lower IOP (B) than what would otherwise have occurred (A).

Anti-Inflammatory Fibrosis Suppression Therapy.

Direct control of bleb fibrosis can be achieved using systemic anti-inflammatory agents. Initial trials of anti-inflammatory agents demonstrated that their effects could be detected by the resultant fall in IOP when given during the hypertensive stage of bleb inflammation. Significant anti-inflammatory effect was demonstrated with orally administered glucocorticoids, some nonsteroidal anti-inflammatory agents and colchicine. When given singly, none of these agents produced a marked effect. However, when given in combination these agents reduced postoperative bleb inflammation with its accompanying elevation of IOP and produced a thin-walled stable-stage bleb with excellent long-term IOP control.

The most effective combination of drugs identified to date is oral prednisone 10 mg, a nonsteroidal anti-inflammatory agent (e.g. diclofenac 50 mg) and colchicine 0.3 mg together with topical adrenaline 1–2% and topical atropine 1% all given three times daily for 5–6 weeks after operation (dosage as for a 70-kg healthy adult). Anti-inflammatory fibrosis suppression therapy is particularly advantageous in the most severe cases of glaucoma, such as when there is active intraocular inflammation. However, the development of surgical techniques for delayed aqueous drainage has greatly reduced the need for antifibrosis suppression.

Note that when using implants, this regimen should not be given before the onset of aqueous drainage as it prevents formation of a preformed bleb lining, delays the opening of the tube and increases the incidence of hypotony after the tube opens.

Hypotensive Medication

Indirect control of bleb fibrosis can be achieved by using hypotensive medication postoperatively to maintain normal IOP levels from the time of operation until 10–12 weeks afterwards. Appropriate medications include topical β-blockers and topical or systemic carbonic anhydrase inhibitors. At the first sign of the hypertensive phase, if the IOP rises to more than 20 mmHg a topical β-blocker can be commenced. If necessary, a carbonic anhydrase inhibitor can be added, and the dosage adjusted to maintain the IOP below 30 mmHg. Once the vascular congestion of the hypertensive stage has passed, usually 6–7 weeks after the onset of drainage, the IOP returns to normal. This technique further reduces the need for anti-inflammatory agents, reduces bleb capsule thickness and increases permeability of the stable-stage bleb.

Occasionally, in steroid responders, the IOP does not decrease. In these cases, topical steroids should be discontinued allowing the IOP to normalize within 1–2 weeks. Miotics, prostaglandin analog, and adrenergic agents that may be proinflammatory should not be used during this period.

Antimetabolites

Perioperative use of mitomycin C or 5-fluorouracil with implants does not improve IOP control. Both agents inhibit wound healing and may cause exposure of the implant due to breakdown of the overlying tissues. Their use is, therefore, not recommended.

Indications

Molteno implants are considered in cases where simple drainage operations such as trabeculectomy are unlikely to provide safe long-term IOP control. Current indications for using implants include:

  • 1.

    Infantile and juvenile glaucoma.

  • 2.

    Aphakic or pseudophakic glaucoma.

  • 3.

    Traumatic glaucoma.

  • 4.

    Uveitic glaucoma.

  • 5.

    Glaucoma secondary to previous intraocular surgery.

  • 6.

    Neovascular glaucoma.

  • 7.

    Failed previous trabeculectomy ( Table 111-1 ).

  • 8.

    Complications of trabeculectomy on the fellow eye.

  • 9.

    Patients intolerant of, or who cannot cooperate with, the medication regimen.

Preoperative Considerations

Preoperative management involves reducing the IOP to as near normal as possible. This may require the use of hypotensive medication at a level that could not be tolerated in the long term. If the IOP can be maintained near normal even for a short time, this will reduce the final thickness and increase the long-term permeability of the bleb capsule.

Anesthetic Considerations

The operation is performed on an outpatient basis in most cases. Anesthesia may be local or general.

The Molteno Implants

Molteno implants comprise an injection-molded polypropylene plate and silicone tube ( Fig. 111-1 ), and are available in several styles. The single-plate implant (area 137 mm 2 ) has an outer circular ridge containing a triangular pressure-ridge that connects with the drainage tube. A smaller single-plate pediatric implant (area 50 mm 2 ) designed to fit on a 12-mm microphthalmic globe is also available. Double-plate implants (area 274 mm 2 ) are available in right and left models and consist of a single-plate implant joined to a second single-plate without the triangular pressure-ridge by a connecting tube.

The third-generation Molteno3 implant is a single-plate implant. However, it differs from earlier devices in that it has a thinner and more flexible episcleral plate, is available in two sizes (area 175 and 230 mm 2 ), the height of the outer ridge has been reduced and the outline of the pressure ridge modified from triangular to elliptical ( Fig. 111-1 ). These changes enhance the action of the pressure ridge by limiting postoperative hypotony and reduce IOP to low-normal levels by providing sufficient drainage area on a single-plate implant. The surgical procedure for insertion of a Molteno3 implant is the same as that described for other Molteno glaucoma drainage devices, with the advantage of being easier to insert.

Operative Techniques and Modifications

Choice of Implant

The plate area necessary for IOP control depends on patient age, glaucoma severity and previous ocular history. In general, the greater the amount of aqueous to be drained and the stronger the patient's fibrosing response the greater the area required for drainage. The following recommendations are a general guide for single- and double-plate implants, and subject to surgical experience and clinical judgment.

Infants aged less than 18 months, irrespective of glaucoma severity, produce thin bleb capsules and require only single-plate implants. Similarly, frail patients over 70 years of age, particularly those who have been on long-term systemic steroids, produce less fibrous bleb capsules such that single-plate implants provide adequate drainage in most cases. A single-plate implant is used in eyes with a history of cyclodestructive or multiple intraocular procedures, as reduced aqueous secretion from the ciliary body may lead to phthisis if a double-plate implant is used. In such cases, it is prudent to insert a single-plate implant and add a second plate later, if necessary. A single-plate implant is indicated for mild cases of glaucoma in which the IOP can be reduced to normal levels with hypotensive medication. A pediatric implant is used when the eye is microphthalmic.

Older children and adults in good general health produce thicker and less permeable bleb capsules, even in less severe cases of glaucoma, and usually require double-plate implants. Double-plate implants should also be used for eyes with a preoperative IOP above 25 mmHg despite two or more hypotensive agents, and eyes with a history of failed drainage operations irrespective of age.

Since 2004, evaluation of the Molteno3 implant suggests that the 175 mm 2 Molteno3 implant should be used in all cases except young patients and larger eyes in which the 230 mm 2 Molteno3 implant is preferred.

Choice of Surgical Technique

Delayed Versus Immediate Drainage of Aqueous.

Molteno implants can be inserted for delayed or immediate drainage of aqueous. The advantages of delayed aqueous drainage are such that the Vicryl tie technique is almost always used. Immediate drainage of aqueous, however, is necessary in acutely inflamed eyes and when immediate IOP reduction is required, e.g. acute neovascular glaucoma, uveitic glaucoma and when the eye contains blood after trauma. Photocoagulation of underlying retinal disease and/or anti-inflammatory fibrosis suppression therapy can be used to minimize the resulting hypertensive stage.

Delayed drainage allows time for tissues to heal and form a thin bleb capsule (preformed bleb) around the implant. During this time the IOP is controlled either with hypotensive medication or by making a relieving Sherwood slit in the side of the translimbal tube at the time of operation. The slit functions as a safety valve and releases aqueous if the IOP rises above normal levels. It ceases to function about 4 weeks after operation as the Vicryl tie dissolves and the tube opens allowing drainage of aqueous into the preformed bleb. This avoids postoperative hypotony, reduces the inflammatory response that occurs at the onset of aqueous drainage and results in a thinner bleb lining with superior long-term IOP control.

Quadrant Selection.

The superior nasal or superior temporal quadrants are preferred. Tenon's fascia is thicker in the superior nasal quadrant and minimizes the chance of late tube erosion through conjunctiva. Surgical exposure, however, is better in the superior temporal quadrant.

The inferior quadrants may also be used when superior quadrant access is limited. The inferior temporal quadrant is preferred in order to minimize the risk of diplopia that may occur in patients with good vision in both eyes if the inferior nasal quadrant is used.

In eyes containing silicone oil, the implant can be placed superiorly or inferiorly. Any silicone oil entering the tube drains to the bleb, and silicone oil that rarely blocks the ostium can be cleared with neodymium:YAG laser.

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