CONCEPT STUDY
Research type
Research Study
Full title
COmparing the effectiveness of phacoemulsificatioN + ECP lasEr and Phacoemulsification alone for the treatment of primary open angle glaucoma in patients with cataract – a randomised controlled Trial (CONCEPT STUDY)
IRAS ID
263262
Contact name
K. Sheng Lim
Contact email
Sponsor organisation
Guy's and St Thomas' NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, months, days
Research summary
Laser endoscopic cyclophotocoagulation (ECP) has been used to treat glaucoma for over 20 years and is usually used in conjunction with cataract surgery. In the US it is one of the most commonly performed cataract ‘plus’ surgeries but take-up of ECP laser has been lower in the UK and Europe, partly due to a lack of robust clinical evidence from randomised controlled trials justifying its use in routine practice. More recently the advent of minimally invasive glaucoma surgery techniques (MIGS) has increased the options available for cataract ‘plus’ surgery. Without randomised controlled trial data for the use of ECP laser in this context the increasingly popular use of MIGS devices, such as iStent (the current market leader) may further marginalise the use of ECP laser for cataract ‘plus’ surgery in patients with Primary Open Angle Glaucoma and cataract.
We plan to conduct a randomised controlled trial comparing cataract surgery alone versus cataract surgery plus ECP laser surgery to evaluate the added use of ECP laser for the treatment of glaucoma in patients with glaucoma and cataract. We will compare the efficacy of these interventions for the treatment of glaucoma based on clinical outcomes and also undertake a cost-benefit analysis taking into account the cost of surgery, reductions in clinical time allocation for procedures, the frequency of intra- and post-operative complications, any reduced need for topical glaucoma treatments post-surgery, and the frequency with which further glaucoma filtering surgery is needed for patients in each group.We anticipate that 160 patients (80 in each arm) will be adequate to detect a difference in efficacy between cataract surgery + ECP versus cataract surgery alone. Prior to data collection before surgery and at one-year and two-years post-surgery patients will undergo treatment wash-out (28 days minimum) of any eye drops they use for their glaucoma.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/0027
Date of REC Opinion
24 Feb 2020
REC opinion
Further Information Favourable Opinion