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Surgery Glaucoma
Figure 1: SOLX Gold Shunt Table 1: Demographics of SOLX Gold Shunt Study Population
Patient Demographic n=85 (%)
Mean age ± standard deviation 66.7±11.9 –
Gender Male 36 42
Female 49 58
Study eye Right eye 41 48
Left eye 44 52
Lens status Phakic 24 28
Aphakic 3 4
Pseudophakic 55 65
Prior glaucoma surgery* No 17 20
Glaucoma medications were continued or re-started at the physician’s
Yes 68 80
Glaucoma type Primary open angle 70 82
discretion. Patients were asked to return for follow-up visits at day one
Uveitic 4 5
and weeks one, four, 12, 26 and 52 for examination and re-measurement
Pseudoexfoliative 11 13
of IOP and visual acuity.
Closed angle 4 5
Pigmentary 1 1
Results Neovascular 1 1
The mean IOP measurements at follow-up for the Gold Shunt are shown in
Pseudophakic 1 1
Table 2. The type and number of glaucoma medications already prescribed
Other 3 4
for use by the patient were also recorded for each patient at baseline and all
* Eyes may have had more than one prior surgery.
follow-up visits. The mean IOP (standard deviation [SD]) at baseline was 27.6
Table 2: Follow-up Data After Gold Shunt Implantation
(7.6) mmHg. Following Gold Shunt implantation, an immediate 65.5% drop
in mean IOP to 9.2 (6.7) mmHg was observed on day one, which stabilised Gold Shunt (n) Mean IOP Mean Mean Number of
to 18.1 (6) mmHg and 18.2 (4.5) mmHg at 26 and 52 weeks, respectively,
(mmHg ± SD) Reduction (%) Medications ± SD
representing a mean IOP reduction of about 34%. Glaucoma medication
Baseline 85 27.6±7.6 – 2.55±0.94
use was seen to drop from a baseline average of 2.55 (0.94) medications to
Day 1 83 9.2±6.7 65.5 0.25±0.73
Week 1 83 13.±7.2 49.3 0.34±0.88
1.03 (1.08) at 26 weeks and 1.16 (1.04) at 52 weeks.
Week 4 83 18.2±7.2 30.1 0.69±0.91
Week 12 74 17.4±5.6 32.3 0.96±1.02
Complications were typically minor and infrequent. The most commonly
Week 26 71 18.1±6 32.0 1.03±1.08
reported complication was mild hyphema (grade 1 or 2, <3mm) in 37 of 85 Week 52 48 18.2±4.5 33.7 1.16±1.04
eyes (44%), which typically completely resolved without intervention by four
weeks post-operatively. Mild hypotony (IOP between 3 and 5mmHg) was
IOP = intraocular pressure; SD = standard deviation.
reported in 12% of cases in the first week post-operatively, but also resolved there is a learning curve of three to four implants to achieve consistent
completely by the week four follow-up visit. Seven cases of shunt–cornea proficiency with implantation. Overall, post-operative complications were
touch were reported, primarily in the first patients to receive the shunt and minor and easily managed, with the most commonly seen – mild to
less frequently reported as the surgeons gained more experience with the moderate hyphema and mild hypotony – self-resolving in a short period of
implantation technique. Instances of all other complications (choroidal time, thus supporting the safety profile of the device. Furthermore, the 24-
effusion, haemorrhage or detachment, shunt migration and synechia) were carat gold material of the device was shown to be extremely well tolerated
low: typically <5% if recorded at all. by the eye, without significant inflammatory response.
Discussion Early reports of new Gold Shunt designs that provide greater aqueous
In this study, the Gold Shunt demonstrated the capacity to reduce IOP flow are encouraging as they may allow lower target IOPs to be reached.
an average of about 34% at the 52-week follow-up visit with a concomitant Furthermore, additional clinical studies will provide more experience with
average reduction in glaucoma medication of about 1.4 medications. the Gold Shunt and a better understanding of its mechanisms of action,
Choosing to leave patients on their baseline medications may produce lower allowing new ways of improving clinical outcomes to be developed. ■
target IOPs.
Acknowledgement
Overall, the Gold Shunt procedure is straightforward, much like a cataract The author would like to recognise Judy Lin, MSME, for her assistance with
procedure, leaving quiet eyes following surgery. Most physicians will find the biostatistical analysis used in the preparation of this article.
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44 EUROPEAN OPHTHALMIC REVIEW
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