A UK Case Series of Phaco-ECP

Aims: Cataract surgery with combined endo-cyclophotocoagulation (phaco-ECP) remains a relatively new procedure for glaucoma specialists. Problems associated with trans-scleral photocoagulation and a lack of long-term data can cause reluctance to introducing the procedure. However, published data has shown that phaco-ECP is a valuable additional treatment for patients with concomitant cataract and glaucoma being low risk, quick and cost effective. Our retrospective case study reviews the outcome of a cohort of patients treated in one UK hospital from 2009-2013.


Introduction
The aim of this study was to establish the effect of phaco-ECP on management of glaucoma patients. The main outcome measures are effect on intraocular pressure and drop requirement as well as complications related to the procedure. There are an estimated 66 million people with glaucoma worldwide [1] and glaucoma remains an important cause of blindness with a reported 12.5 million people blind from glaucoma. Glaucoma is classified as the leading cause of avoidable blindness worldwide together with cataract [2]. In England there are approximately 480,000 people diagnosed with primary open angle glaucoma (POAG) having over a million glaucoma related outpatient visits in the hospital eye service annually [3]. The approximate corresponding figures for the USA suggests 10 million visits yearly [4].
In addition, cataract surgery is the most common operation performed on the NHS with 340,809 cataract operations performed in UK 2012/2013 (50 per cent increase since 1998/1999) [5]. Finally, there is a growing trend to combine cataract extraction in patients with glaucoma with a procedure

Research Article
to lower pressure such as phaco-stenting, phaco trabectome or phaco-trabeculectomy. In terms of cyclophotocoagulation of the ciliary body in order to lower IOP, the trans scleral approach was initially used with cryotherapy and diathermy as well as the more recent Nd:YAG and diode laser. However, this blind approach to treating the ciliary body is associated with a number of complications including pain, inflammation, sight loss and phthisis and thus is usually reserved for blind and painful eyes, eyes with poor visual potential and for whom surgery is unsuitable or unsuccessful. Many glaucoma surgeons have now started using external cyclodiode much earlier due to significantly reduced complications with modern lasers.
The first documented ciliary body laser was in 1986 [6] with the first endoscopic treatment in 1992 by Uram who developed an endoscope and successfully treated rubeotic glaucoma [7]. Chen et al. [8] published successful treatment of 68 cases of refractory glaucoma with endocyclodiodelaser (ECP) in 1997. The biggest cohort with longest follow-up is by Berke's group in Westbury, New York, with over 2000 patients and the longest follow-up in some patients of 13 years. There is also a collaborative ECP group with a cumulatively 5824 eyes with follow up 1 to 13 years [9,10]. There are also some UK studies [11,12].

Materials and Methods
This was a retrospective case series review of all phaco-ECP procedures between November 2009 and Nov 2013. Previous interventions were not excluded and all glaucoma subtypes included. All laser procedures (ECP) were performed by one consultant. All data gathered was entered onto a proforma and subsequently entered into EXCEL. Data gathered included hospital number, gender, age, date of operation, pre-operative IOP and number of agents used, post-operative IOP and number of agents used. The timepoints for post-operative data included 1 week, 1 month (range depending on actual follow up date 21-37 days), 3 months (2-4 months), 6 months(4-8 months), 12 months (10-14 months), 24 months (20-28 months) and the date and details of the last recorded visit during the audit period. Any intra or postoperative complications were also noted as well as any further interventions required. Phaco-ECP combines phacoemulsification and intraocular lens implant (IOL) with ciliary body endocyclophotocoagulation.

Indications for performing the surgery are
Progression of glaucoma on maximum tolerated topical treatment with co-existing cataract inability to tolerate or instil glaucoma drops (elderly,tremor,dementia,arthritis etc) and coexisting cataract. The endo-cyclophotocoagulation is usually performed towards the end of the procedure either after insertion of the IOL or immediately prior to this.
The most important aspect to bear in mind whilst performing the procedure is to avoid any contact with the iris as this usually results in a very brisk uveitis with fibrin dump postoperatively. Always ensure the sulcus remains fully inflated with visco-elastic and always remove all the visco-elastic from the bag first at the end of lens implantation as this will allow a much fuller view and treatment area of the ciliary processes. The main corneal incision is used to insert the laser probe into the anterior chamber after inflating the ciliary sulcus with visco-elastic. The probe is advanced forward under the iris and pointing towards the ciliary processes. The laser, which is not in the visible spectrum, has a guiding Xe-Ne beam. The laser is set to 'painting' mode allowing a continuous 'painting' of the ciliary processes whilst the effect of the treatment is observed on a monitor adjacent to the operating table showing the view through the fiber optic video cable of the laser probe ( Figure 1). The operating microscope is only used in order to visualize the insertion of the viscoelastic and a safe insertion of the laser probe. The effect of the laser on the ciliary bodies is a visual change in the shape and colour of the processes. They shrink and turn from a brownish colour to white in eyes without pseudo-exfoliation (PXE) (Figure 2). There is a marked difference both in the visual appearance as well as the reaction to the laser in patients with PXE with minimal shrinking and colour change (Figure 3). The author enlarges the side port used in the phacoemulsification to allow for a full 360 degrees treatment.   The probe consist of a Xenon light source, a fibre optic video cable, a visible aiming beam from a Xe-Ne laser and the laser itself, an 810nm wavelength diode laser (Figure 4). The laser is operated via a foot pedal. Because of the increased risk of a brisk uveitis, including a fibrin dump, all patients receive intra cameral dexamethasone 0.2ml (0.8mg)-drawn from intravenous dexamethasone preparation 4mg/ml at the end of the procedure after the standard intracameral Cefuroxime 0.1ml (1mg). Two hourly topical steroids and 4x daily antibiotic drops are prescribed. The first follow-up appointment is 1 to 3 days post procedure with the main aim of ensuring that fibrin dump or pressure spikes are identified early. Pressure spikes are treated with a paracentesis 'burping the wound' with repeat pressure check in 24 hours. Fibrin dump is treated with subconjunctival dexamethasone (4mg in 1ml) and reviewed in 2 to 3 days. The vast majority of eyes in this series required no intervention and the two hourly drops are reduced to 4x/day and stopped 4 weeks later (5 weeks total). Patients were told to stop all glaucoma drops in the operated eye until review.

Results and Discussion
The study included 328 eyes of 207 patients. The mean age of participants was 78.8 [SD +-10 years, range 62-100]. The group consisted of 53% males and 48% females. The longest follow-up was 48 months. The mean follow-up period was 24 months. 154 eyes were followed up for 12 months and 105 for 24 months or more. The glaucoma subtypes included were as per ( Figure 5). Pre-operatively, patients used a mean of 1.72 agents [SD 1.07, range 0-4] and pre-operative IOP mean was 17.1 [SD 5.3, range 15-41]. See also the attached charts for number of drops used and overall IOP change over time in (Figures 6-9). The overall reduction in IOP at 24 months was 24.0% and the overall reduction in the number of agents used at 24 months was 38.0%. See (Table 1 and 2) for details.       As expected with destruction of ciliary epithelium, the documented complications are all related to increased inflammation (Table 3). All complications resolved without sequelae. Intracameral steroid and intensive drops in the first week is crucial to ensure smooth recovery. Further surgery was required in 12 eyes (3.6%) and consisted of 9 MMC Trabeculectomies, 2 Ahmed valve implants and 1 external cyclodiode laser.

Conclusion
We are aware of a number of limitations of this study. First of all, there is a presumed and previously reported improvement in IOP following phacoemulsification alone [13,14]. This study did not include any phaco alone controls. However, the effects of phaco alone, according to published studies as referenced, appears to be short-lived, with IOP increasing again after about one year. The effects of phaco-ECP appears consistent over the time of this study. A further case controlled study is planned. Furthermore, we are aware of an observer bias in measuring IOP both pre and post-operatively. There was no blinding during this study, but IOP was measured by any member of the team who saw patients during follow-ups and many of the observers were not officially part of the study nor briefed on desired outcomes but managed the patients as per their clinical judgment. We are also aware that a longer term follow-up is advisableA randomized, controlled trial would be able to prove more accurately the outcomes from this fairly new procedure.
The glaucoma specialist who performed the phaco-ECP noted that a decrease in the number of trabeculectomies since the introduction of phaco-ECP. The overall reduction was approximately 50% since introduction of Phaco ECP. With the phaco ECP procedure there is a significant reduction in follow up appointments in the initial post operative period compared to glaucoma drainage surgery . There were on average only two postoperative visits required before normal glaucoma monitoring intervals where resumed. Overall 44% of patients were on 1 drop only after 1 year and 33.3% of eyes were drop free at 12 months. For those who manage glaucoma it is clear how this can have a significant impact on patients who often have comorbidities and may find drop administration difficult and also suffer side-effects from topical treatments. In addition, this may prove a significant cost benefit to the health economy.
No adverse effects were noted apart from increased inflammation (compared to phaco alone) with associated increase in corneal oedema and macular oedema -all resolved completely. Intracameral steroid and intensive drops in 1st week appears crucial to ensure a smooth recovery. No contraindications to treatment of any patients were identified from the patients included in this study. In our group, all patients were treated with 360 degree laser. We are aware that some groups may treat 360 degrees or less. We are unable to comment on any difference in outcome that this may have as all our patient were treated with the same protocol of 360 degree coverage.

Summary
This procedure could be seen as value added phaco as it is easy to do and addresses two pathologies in one operation. It leads to drop reduction and better, consistent IOP control and has a low complication rate with no documented cases of hypotony. It leaves the conjunctiva untouched in case of need for further drainage surgery and gives a unique view of anatomy. It is also a fun and interesting procedure once mastered! It is noted in this study that the needs for drops modestly increase over time .