Clinical investigation of the eyeWatch glaucoma drainage device
Research type
Research Study
Full title
Clinical investigation of the eyeWatch glaucoma drainage device
IRAS ID
227705
Contact name
Sheng Kin Lim
Contact email
Sponsor organisation
Rheon Medical SA
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 28 days
Research summary
Research Summary
This study aims to test a new medical device, called the eyeWatch, used in filtering surgery for the treatment of glaucoma. This medical device has the following property: it allows better control of intraocular pressure in the initial postoperative phase by adjusting aqueous flow going through the device. The target criteria for the study are defined as: keeping intraocular pressure in target range; reducing the number of anti-glaucoma drugs; evaluating the number and type of postoperative complications. So far, this device has been already tested on 20 patients in Switzerland.
This study is related to an investigational medical device which has not yet received market approval in the UK. The study will be carried out in the St. Thomas’ Hospital in London and the Manchester Royal Eye Hospital in Manchester and will involve participation of approximately 15 patients for each hospital. The study will last approximately 18 months. Patients will be monitored for 12 months after surgery.Summary of Results
The results of the study have shown that the eyeWatch implant brings a significant reduction of the intraocular pressure to patients suffering from glaucoma. The number of medications has been significantly reduced after the implantation of the filtering device (p < 0.05). The failure rate was 7%, with 2 patients experiencing IOP (intraocular pressure) above the defined limit (21 mmHg) for 2 consecutive postoperative visits after 1 month. Complete success rate (IOP within the defined range and no glaucoma medication needed) was 47% and overall success rate was 93%. In addition, the implantation of the eyeWatch system was relatively simple for experienced surgeons as evidenced from the feedback of their experience.
Furthermore, the adjustment of the eyeWatch device peri- and post-surgically, was efficient as evidenced from the results and feedback from physicians’ experience was satisfactory.The type and rate of adverse events observed during the study are consistent with the usual practice of filtering tubes in the management of glaucoma. The rate of occurrence in this clinical investigation with the eyeWatch system, is comparable to the rate of complications found in the literature for equivalent devices (e.g., Baerveldt Glaucoma Implant, Ahmed Glaucoma Valve). Thirteen out of 16 adverse events reported did happen during the early post-operative period. Most of them (77%) are mostly related to the surgical procedure rather than to the device itself.
The learning time by the surgeons needs also to be considered, especially with respect to the surgical placement of the eyeWatch implant. Most of the adverse events did occur for the first half of the patients (10 out of 14) recruited.
It is worth mentioning, that most of the patients taking part to this study had a complicated glaucoma history, with multiple filtering surgeries in the past. Thus, this should be taken into account when considering the overall adverse events rate for this clinical investigation.REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/0190
Date of REC Opinion
27 Mar 2018
REC opinion
Further Information Favourable Opinion