Early results of a Pilot Study Randomised Controlled Trial of Phaco-Endocycloplasty vs Phaco-Trabeculectomy in medically controlled and uncontrolled Primary Angle Closure Disease: Early results of a Pilot Study Vanita Pathak-Ray FRCS (Ed), FRCOphth (Lon)1 Swati Badkare MS2, Siddharth Dikshit DNB2, Nikhil Choudhari DNB2 1Director Glaucoma Services, Centre for Sight, Hyderabad, India 2VST Centre for Glaucoma Care, L V Prasad Eye Institute, Hyderabad, India. Background Cataract and glaucoma frequently co-exist The lens – due to its relatively anterior position, thickness, increased lens rise - plays an important role in the pathogenesis of the spectrum of Primary Angle Closure Glaucoma (PACG) and its removal is advocated early, rather than late in the disease When glaucoma is uncontrolled medically or shows progression in the presence of cataract, current gold standard of Phaco-trabeculectomy (P-T) is a widely practiced procedure However, PT is not without pitfalls - it is associated with increased inflammation (a cause for failure) and unique vision-threatening complications like hypotony and bleb related complications, including life-long risk of bleb-associated-endophthalmitis (BAE) Thus it becomes imperative to find newer, safer but equally efficacious solutions for PACG - one such modality is combining endocycloplasty (ECPL) with phaco (P-E) A pilot study of 10 eyes by the lead author yielded encouraging results (Table 1): at median 18 months follow-up, P-E significantly reduced IOP, need for *AGM, with successful early visual rehabilitation Results 42 eyes of 39 patients; 22 females 22 eyes in P-E group; 2 excluded as laser not per protocol. 20 eyes in P-T Median f/u 6 months in both groups Table 2: Pre-operative characteristics Phaco-Trab n=20 Phaco-ECPL p value Age, Median (IQR) 59 (13) 65 (12) 0.23 IOP mmHg, Median (IQR) 17 (13) 20 (15.5) 0.76 Uncontrolled IOP n=10 0.25 AGM, Median (IQR) 3 (2) 3 (1) 0.93 LogMAR BCVA, Median (IQR) 0.4 (0.3) 0.3 (0.25) 0.9 Post-LPI occludable n=14 0.28 Synaechial closure, Median quads, IQR 0 (2) 0 (1.5) 0.62 Lens rise in microns, Median IQR 630 (340) 690 (330) 0.5 VFI % 66 (13.5) 36 (47.5) 0.14 Table 3: Post-operative characteristics Table 1: Results of a pilot study of Phaco-ECPL in Angle Closure Disease Phaco-Trab n=20 Phaco-ECPL p value IOP mm Hg, Median (IQR) 16 (6) 15 (4.25) 0.8 AGM, Median (IQR) 0.9 LogMAR BCVA, Median (IQR) 0.1 (0.25) 0.7 Parameter Pre Phaco-ECPL Post Phaco-ECPL p Median IOP mmHg (IQR; range) 20 ( 5.5; 11-46) 15.5 (5.75; 12-40) <0.01 Median *AGM 3 (IQR 1.75) Median LogMAR BCVA 0.55 (IQR 0.4) 0 (IQR 0.075) *AGM – Anti-glaucoma medication Purpose To investigate the efficacy and safety of endocycloplasty compared with trabeculectomy, when these are combined with phacoemulsification in medically controlled and uncontrolled Primary Angle Closure Disease, post laser peripheral iridotomy (LPI) Methods Study design: Prospective, interventional, comparative randomised control trial Inclusion criteria: Subjects over the age of 30 years with Primary Angle Closure disease (Primary Angle Closure, PAC and Primary Angle Closure Glaucoma, PACG), post LPI, with visually significant cataract Exclusion criteria: Ocular surface infection Previous intra-ocular surgery Secondary angle closure glaucoma One-eyed subjects Depression of any paracentral point on 10-2 HVF to 0 dB Computer generated randomized sequence of either study procedure (P-E or P-T)) for all indications of combined surgery Uncontrolled IOP Controlled IOP on 3 or more AGM Involvement of fixation on 10-2 HVF Subjects intolerant to or unable to afford AGM also underwent randomisation. Table 4 : Complications and interventions Complications Phaco-Trab Intervention Phaco-ECPL Intra-op AM n=1 IZHV n=1 ZD n=1 ECR n=1 Post-op Fibrinous uveitis n=3 Yag to membrane n=1 Fibrinous uveitis n=5 Repeat LPI n=2 Hyphaema n=1 - Leak n=4 BCL in all Encysted bleb n=2 AM n=1 Yag hyaloidotomy Failure n=1 Bleb revision n=1 Trab n=1 . Complication n=13 in P-T and n=7 in P-E (p=0.5) No patient lost vision in either group Discussion Primary Outcome Measure: Intra-ocular Pressure (IOP) Secondary Outcome Measure/s: Best-corrected LogMAR visual acuity (BCVA) Anti-Glaucoma medication (AGM) Complications Our study is unique as studies on ECP hitherto have mainly concentrated in open angle or refractory glaucomas with moderate success only. The ability of P-E in IOP control in angle closure appears to be via a two-pronged mechanism ECPL helps to anatomically modify the angle recess, as seen in intra-operative ASOCT – more than phaco alone; change in angle recess is also seen in post-operative UBM (1st prize winning video at WGC, Helsinki 2017) Photocoagulative effect on ciliary processes Advantages: Low risk of hypotony as only 2-3 quadrants treated, post-op quieter eyes With swifter recovery, speedier visual rehabilitation, Adds only 5-10 mins to phaco Most importantly it does not preclude future trabeculectomy as conjunctiva is not compromised. Surgical Procedures Phaco-ECPL (P-E) Performed in the OR under regional anaesthesia Clear corneal phaco and intra-ocular lens implant (PCIOL) inserted Endoscope was introduced through the phaco wound, with delivery of laser under direct vision after creating space in sulcus with cohesive viscoelastic Laser was aimed at the ‘tail’ of the ciliary process, as a modification of the ECP process called endocycloplasty (ECPL) Figure 1 Laser power was determined by end-point of whitening and shrinkage of ciliary body for 220-270 degrees; ‘pops’ were strictly avoided (starting point 500 mw X 2000 ms) At the end of the procedure, viscoelastic washed and sub-conjunctival steroid administered (Dexamethasone 2mg) Phaco-Trab (P-T) Performed in the OR under regional anaesthesia Phaco and trabeculectomy done through separate sites – both incisions superior Trab – conjunctival incision supero-nasal in the right eye (Figure 3 below) and supero-temporal in the left. Sponge application of Mitomycin C (MMC) 0.4 mg/ml used for 2 minutes after rectangular scleral flap was raised Phaco via a clear corneal supero-temporal wound in the right eye Figure 2 (or supero-nasal in the left eye) Post PCIOL insertion, phaco wound sutured with 10/0 nylon At the end of the procedure, sub-conjunctival steroid was administered (Dexamethasone 2mg) Conclusion This pilot study of P-E vs. P-T suggests that in the short term P-E is as efficacious as P-T in angle closure glaucoma, without the incumbent bleb-related complications. Further follow-up is required to ascertain whether this is sustained.   References Uram M. Combined phacoemulsification, endoscopic ciliary process photocoagulation, and intraocular lens implantation in glaucoma management. Ophthalmic Surg. 1995; 26:346-52. Ahmed IK, et al. Endoscopic cycloplasty in angle closure glaucoma secondary to plateau iris. Poster presented at: AGS Annual Meeting; March 5-8, 2009, San Diego, CA. Hollander DA et al Management of plateau iris syndrome with cataract extraction and endoscopic cyclophotocoagulation. Exp Eye Res 2017 May;158:190-194 Francis BA et al Endoscopic Cycloplasty (ECPL) and Lens Extraction in the Treatment of Severe Plateau Iris Syndrome. 2016 Mar;25(3):e128-33 Figure 1 : laser beam (red dot) aimed at the tail of the ciliary process Figure 2 : Separate site phaco-trab P-FS-332 Financial Support: None Conflict of Interest: None relevant email: vpathakray@gmail.com