Condition category
Eye Diseases
Date applied
26/02/2017
Date assigned
09/03/2017
Last edited
12/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Primary open angle glaucoma is a condition where the fluid in the eye cannot drain properly, which increases the pressure inside the eye and puts pressure on the optic nerve, which connects the eye to the brain. This can lead to loss of vision. This study is testing the XEN Gel Stent, a new device for the surgical treatment of glaucoma. This device is a tiny tube that is implanted into the eye to reduce the pressure by allowing fluid to drain to a small reservoir (bleb) just under the eye surface. The aim of this study is to assess the effectiveness and safety of the XEN Gel Stent and to investigate the bleb both clinically and using hi-tech methods in order to see if any parameter could guide the surgeons in obtaining better results.

Who can participate?
Patients age 20-70 with primary open angle glaucoma who cannot get their intraocular (eye fluid) pressure sufficiently low on between one and four anti-glaucoma medications

What does the study involves?
All patients undergo implantation of the XEN Gel Stent. Patients who have cataracts also undergo cataract surgery at the same time. The bleb is assessed using a microscope and a scan of the eye at 1, 3, 6 and 12 months after the operation. Safety is assessed by recording any adverse events (side effects) and loss of vision.

What are the possible benefits and risks of participating?
The potential benefits are to be free of or to reduce the burden of taking anti-glaucoma drugs. The risks are minimal although little is known on the long-term effectiveness of the device.

Where is the study run from?
University of Torino (Italy)

When is the study starting and how long is it expected to run for?
January 2014 to August 2015

Who is funding the study?
University of Torino (Italy)

Who is the main contact?
Dr Antonio Fea
antoniomfea@gmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Antonio Fea

ORCID ID

http://orcid.org/0000-0002-6551-6054

Contact details

Eye Clinic
University of Torino
Via Juvarra 19
Torino
10100
Italy
+39 (0)115 661 566
antoniomfea@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Xen Gel Stent implantation in patients affected by primary open angle glaucoma: safety, filtering bleb analysis, intraocular pressure and glaucoma medication use variations within one year

Acronym

Study hypothesis

Xen Gel Stent is a new and promising minimally invasive glaucoma surgery that creates a filtering bleb in the subconjunctival space and attempts to avoid the major complications related to standard filtering surgery. Safety and efficacy outcomes at one year after stent implantation in primary open angle glaucoma patients (as a solo procedure or combined with cataract surgery) have been poorly reported till now. Moreover, a filtering bleb assessment using different techniques (i.e. OCT and in vivo confocal microscopy) has never been provided.

Ethics approval

Ethics Committee Ophthalmic Hospital Turin, January 2014, ref: MS-001

Study design

Prospective interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Primary open angle glaucoma, cataract

Intervention

Patients underwent implantation of the Xen Gel Stent (AqueSys Inc, Aliso Viejo, CA, USA), a minimally invasive glaucoma surgery device that creates a subconjunctival filtering bleb through an ab interno approach. In some cases (i.e. patients with concurrent age-related cataract) cataract surgery was performed at the same time. Biomicroscopy, in vivo confocal microscopy (IVCM) and anterior segment OCT (AS-OCT) were used to assess bleb morphology at 1, 3, 6 and 12 months postoperative. Safety was determined by the incidence of adverse events, loss of best corrected visual acuity (BCVA), Humphrey visual field, and endothelial cell count.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Intraocular pressure, measured using Goldmann applanation tonometry (GAT) at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months
2. Visual acuity, measured with the standard ETDRS charts at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months
3. Incidence of adverse events, measured using a pre-built questionnaire at baseline, 1 day, 7 days, 1, 3, 6, 9 and 12 months
4. Visual field, measured using Humphrey 24-2 at baseline and 12 months
5. Endothelial cell count, measured using Konan Cell Check XL at 1, 3, 6 and 12 months

Secondary outcome measures

Bleb morphology, assessed using AS OCT (RTVue-100, Optovue) and in vivo confocal microscopy (HRTII/Rostock Cornea Module) at baseline, 1, 3, 6 and 12 months

Overall trial start date

01/01/2014

Overall trial end date

31/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with a diagnosis of POAG with uncontrolled IOP (defined as ≥18 mm Hg and ≤33 mm Hg on between one and four anti-glaucoma medications)
2. A healthy and mobile superior bulbar conjunctiva
3. Age 20-70

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

11

Participant exclusion criteria

1. Previous corneal and glaucoma surgery
2. Diagnosis of glaucoma other than POAG
3. Corneal opacities
4. Ocular diseases other than glaucoma

Recruitment start date

12/06/2014

Recruitment end date

20/12/2014

Locations

Countries of recruitment

Italy

Trial participating centre

Ospedale Oftalmico
Dipartimento di Scienze Chirurgiche - Clinica Oculistica V. Juvarra 19
Turin
10122
Italy

Sponsor information

Organisation

University of Torino

Sponsor details

Eye Clinic
Via Juvarra 19
Torino
10100
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Torino

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal

IPD sharing plan
The datasets generated and analysed during the current study will be included in the subsequent results publication

Intention to publish date

09/03/2018

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2017: Internal edit.