Year of introduction
Tube diameter/material
Plate size/material
Resistance mechanism
Molteno
1969
0.63 mm OD
0.30 mm ID
Silicone
135 mm2
Polypropylene
None
Baerveldt
1990
0.63 mm OD
0.30 mm ID
Silicone
200, 250, 350, 425, 500 mm2
Silicone
None
Ahmed
1993
0.63 mm OD
0.30 mm ID
Silicone
185 mm2
FP7 model silicon plate with silicone valve in polypropylene box
Venturi valve
5.2 Evaluating Glaucoma Drainage Device Results
Most GDDs have been developed in a virtual publication vacuum, with little available data to substantiate manufacturers’ claims for flow performance or biocompatibility (Prata et al. 1995). Clinical data are largely restricted to uncontrolled retrospective case series (Krawczyk 1995) with variable follow-up and differing definitions of surgical success. Evaluation is further complicated by the heterogeneity of inclusion criteria. Series include a variable proportion of complex cases, such as neovascular glaucoma, in which there is a higher risk of filtration failure.
Overall success rates, in terms of IOP control, appear similar between devices (Table 5.2), with a reasonably high proportion of cases achieving a final IOP in the target range at 1 year after surgery. Half to two-thirds of these cases still require glaucoma medications, however, target IOPs in the low teens (≤16 mmHg) may be more realistic in terms of preventing disease progression than commonly adopted target levels (≤21 or 22 mmHg).
Table 5.2
Success rates of current GDDs
Type | Investigator | Year | Diagnosis | No. of eyes | Follw-up (months) mean ± SD | Success criteria | Success rate w/o medication | Success rate with medications |
---|---|---|---|---|---|---|---|---|
Molteno | ||||||||
SP and DP | Mills et al. (1996) | 1996 | Mixed (25 % neovascular) | 77 | 44a | IOP ≤22 mmHg and NFCb | 23 % | 34 % |
SP | Mermoud et al. (1993) | 1993 | Neovascular | 60 | 24.7±13.4 | IOP ≤21 mmHg and NFCb | 17 % | 20 % |
SP DP | Heuer et al. (1991) | 1992 | Mixed (no neovascular) | 50 52 | 14.9±8.9 16.4 ± 6.8 | 5 ≤IOP ≤21 mmHg and NFCb | 10 % 12 % | 40 % 63 % |
SP | Minckler et al. (1988) | 1988 | Mixed (50 % neovascular) | 90 | 17.6 | IOP ≤21 mmHg and NFCb | 7 % | 40 % |
Ahmed valve | Coleman et al. (1995) | 1995 | Mixed | 60 | 9.3a | IOP <22 mmHgc,d and NFCb | NA | NA (78 %)e |
Coleman et al. (1997) | 1997 | Penetrating keratoplastyf | 31 | 16a | IOP <22 mmHgc,d and NFCb,g | 26 % | 39 % | |
Coleman et al. (1997) | 1997 | Pediatric-mixed | 24 | 16.3±11.2 | IOP <22 mmHgc,d and NFCb | 33 % | 38 % | |
Barton et al. (2014) (ABC group) | 2014 | Mixed | 106 | 36 | IOP <22 mmHg c and NFC b,g | 20 % | 84% h | |
Christakis et al. (2013) (AvB study) | 2013 | Mixed | 124 | 36 | IOP <18 mmHg IOP >5 mmHg c and NFC b,g | 13 % | 57 % h | |
Krupin disk | The Krupin Study Group (1994) | 1994 | Mixed | 50 | 25.4±2.4 | IOP ≤19 and NFCb | 47 % | 33 % |
Fellenbaum et al. (1994) | 1994 | Mixed | 25 | 13.2 | 6 ≤ IOP ≤21 and NFCb | 28 % | 36 % | |
Baerveldt 200, 250, 350, 500 mm2 | Seigner et al. (1995) | 1995 | Mixed | 103 | 13.6±0.9 | 5 ≤ IOP ≤22 and NFCb | 45 % | 27 % |
200, 350, 500 mm2 | Sidoti et al. (1995) | 1995 | Neovascular | 36 | 15.7±7.2 | 6 ≤ IOP ≤21 and NFCb | 33 % | 17 % |
350 mm2 500 mm2 | Lloyd et al. (1994) | 1994 | Mixed | 37 36 | 15.5±4.8 14.1±5.4 | 6 ≤ IOP ≤21 and NFCb | 14 % 36 % | 70 % 47 % |
Diameters mixed/not specified. | Barton et al. (2014) (ABC group 3 years) | 2014 | Mixed | 100 | 36 a | IOP <22 mmHg c and NFC b,g | 33 % | 72% h |
350 mm 2 | Christakis et al. (2013) (AvB study) | 2013 | Mixed | 114 | 36 | IOP <18 mmHg IOP >5mmHg c and NFC b,g | 33 % | 86% h |
350 mm 2 | Gedde et al. (2009) (TvT 3 year study) | 2009 | Mixed | 107 | 36 | IOP <21 mmHg IOP >5 mmHg c and NFC b,g | 56 % | 85 % |
Another important caveat concerns attrition rates, or continued increments in the proportion of filtration failures with lengthening postoperative follow-up. Again, evaluation is difficult, with few series including either long-term data or survival analysis (Mills et al. 1996) (Table 5.2). Mills et al. reported a 10 % failure rate per postoperative year in a series including longer-term follow-up for single and double plate Molteno tubes. Extrapolating from this would suggest that many GDDs have a functional lifespan of less than 5 years before failure though fibrous encapsulation. However, the 5-year data from the Tube vs. Trabeculectomy (TVT) study found a 10 % failure rate per year for the first 3 years, and an average of 5 % per year for the subsequent 2 years, which may indicate better long-term results with less complex cases (Gedde et al. 2012).
5.2.1 Tube Use, Tube Type, and Complication Risk
Clinical series reporting GDD procedures are characterized by frequent problems in addition to filtration failure (Table 5.3), with overall complication rates typically around 60–70 % (Heuer et al. 1991; Siegner et al. 1995). While partly attributable to the complex nature of cases typically selected for implantation, the range of complications observed also reflects design and material inadequacies inherent in contemporary GDDs. The origin of most complications can be traced to just two fundamental mechanisms: poor flow control and suboptimal material biocompatibility.
Table 5.3
Cumulative complication rates among currently used GDDs
Implants | Ahmed valve (1990s) | Ahmed valve (recent) | Baerveldt implant (1990s) | Baerveldt implant (recent) |
Studies | Coleman 1995 | ABC 2014 a | Lloyd 1994 | ABC 2014 a |
Coleman 1997 | AvB 2013 b | Sidoti 1995 | AvB 2013 b | |
Coleman 1997 | Smith 1993 | TvT 2009 c | ||
Siegner 1995 | ||||
n = | 115 | 267 | 249 | 354 |
Complication category | Rate (%) | Rate (%) | Rate (%) | Rate (%) |
Choroidal effusion | 14.00 % | 6.00 % | 23.00 % | 9.90 % |
Tube erosion, occlusion, malposition | 17.30 % | 7.90 % | 15.60 % | 9.30 % |
Shallow anterior chamber | 3.50 % | 7.10 % | 16.50 % | 9.60 % |
Persistent corneal edema/decompensation | 3.50 % | 8.60 % | 11.60 % | 11.60 % |
Persistent diplopia/motility disorder | 3.50 % | 8.60 % | 21.00 % | 6.20 % |
Iritis/uveitis | 1.70 % | 4.90 % | 3.60 % | 5.10 % |
Hyphema | 0.00 % | 2.20 % | 11.00 % | 2.80 % |
Vitreous hemorrhage | 3.50 % | 1.10 % | 7.00 % | 1.10 % |
Encapsulated/encysted bleb | 3.50 % | 5.60 % | 1.60 % | 1.40 % |
Retinal/choroidal detachment | 0.00 % | 1.50 % | 5.00 % | 2.50 % |
Phthisis bulbi | 0.00 %
Stay updated, free articles. Join our Telegram channelFull access? Get Clinical TreeGet Clinical Tree app for offline access |