2 Year Outcomes Of The Concept Randomised Controlled Trial: Comparing Cataract Surgery Alone Vs Cataract Surgery With Endoscopic Cyclophotocoagulation

To report 2-year outcomes from the CONCEPT randomised controlled trial, comparing washout IOP in cataract versus cataract + ECP participants Methods: Multicentre RCT in the UK. Participants underwent baseline washout diurnal IOP measurement and were randomised 1:1 perioperatively after uncomplicated cataract surgery to sham or 360 degree ECP. Diurnal washout IOP repeated at 24 months postop.

Randomised controlled trial, multi-centered study 5 centres in UK. 

Participants were recruited from UK teaching hospitals, typically referred from community optometrists.

Study Design

Prospective, multicentre, parallel-group, randomized controlled trial (RCT) conducted across teaching hospitals in the UK, with both participants and investigators masked to treatment allocation. Washout periods occurred at baseline, 12 months, and 24 months.
Sample Size

A total of 162 eyes from 162 patients were enrolled, randomized 1:1 to phacoemulsification alone or phacoemulsification with 360° ECP.

Washout data was available for 64 patients who received ECP and 75 who received cataract surgery alone. Data was found to be non normally distributed so median reductions were compared, showing a -4.5mmhg reduction in the phaco alone arm and -6.0mmHg in the ECP arm (median test 0.03Success rates defined as 20% reduction from baseline and IOP of <21mmHg were found to be higher in the ECP arm, and other adverse evets such as cystoid macular oedema were similar between the two 

ECP demonstrated superior IOP lowering capability compared to cataract surgery alone in patients with open angle glaucoma.