Plain English Summary
Background and study aims
Chronic glaucoma, also known as primary open-angle glaucoma (POAG) is an eye condition which develops when a fluid inside the eye (called the aqueous humor) cannot drain properly, causing pressure (intraocular pressure, or IOP) to build up that can result in damage to the optic nerve and nerve fibres from the retina. It often affects both eyes, generally with one being more affected than the other, and, over time, it can lead to a partial or complete loss of sight. Canaloplasty is a surgical procedure used to treat POAG. It uses a micro-catheter (a tiny tube) to open up the drainage system of the eye (Schlemm’s canal). A sterile, gel-like material (viscoelastic) is then used to open up this canal. The micro-catheter is then removed and a suture threaded through the canal, thus opening it and allowing the IOP to drop to a more normal level. This study aims to look at the flow of the aqueous humor though the eye (aqueous outflow system) using a solution containing viscoelastric and indocyanine green (ICG), to take near-infrared fluorescence images of the inside of the eye.
Who can participate?
Adult patients with POAG being treated with canaloplasty.
What does the study involve?
For each participant in the study, a solution made up of of indocyanine green (ICG) and viscoelastic is injected was injected through a microcatheter into the Schlemm’s canal . Visualization of the outflow pathway is then accomplished using a microscope with filters working in the range of infrared wavelenghts (~ 800 nm). This imaging then can be used to assess the success of the surgery.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
San Giuseppe Moscati Hospital and the University of Molise (Italy)
When is the study starting and how long is it expected to run for?
May 2015 to November 2015
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Professor Ciro Costagliola
ciro.costagliola@unimol.it
Trial website
Contact information
Type
Public
Primary contact
Prof Ciro Costagliola
ORCID ID
http://orcid.org/0000-0001-8477-6188
Contact details
Via De Sanctis
1
Campobasso
86100
Italy
+39 (0)874 4041
ciro.costagliola@unimol.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
In vivo near-infrared fluorescence imaging of aqueous humor outflow structures: a prospective, open, observational single center pilot study
Acronym
Study hypothesis
To visualize the aqueous outflow system in patients affected by primary open angle glaucoma that have undergone canaloplasty.
Ethics approval
Not provided at time of registration
Study design
Prospective open observational single-center pilot study
Primary study design
Observational
Secondary study design
Case series
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Primary open angle glaucoma (POAG)
Intervention
A solution composed of indocyanine green (ICG) and viscoelastic was injected into the Schlemm's canal using the microcatheter during surgery. Visualization of the tracer was accomplished using the microscope PENTERO 900. The progression of the dye along the Schlemm's canal was visualized. The filling of collector channels was observed only in correspondence of the patent portions of the Schlemm's canal.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
In vivo visualization of the outflow pathway, using the OPMI PENTERO 900 microscope, measured during surgery
Secondary outcome measures
Assessment of the working and non working portions of the conventional outflow pathway on the basis of the visualization of the portion filled, measured during surgery
Overall trial start date
30/05/2015
Overall trial end date
30/11/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients affected by POAG undergoing canaloplasty
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Ten patients
Participant exclusion criteria
1. Narrow or closed iridocorneal angle
2. Evidence of any secondary glaucoma
3. Pigmentary dispersion
4. Pseudoexfoliation
5. History of trauma
6. History of uveitis
7. Any type of corneal disease or preceding refractive surgery
Recruitment start date
30/05/2015
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Italy
Trial participating centre
San Giuseppe Moscati Hospital
83100
Italy
Trial participating centre
University of Molise
86100
Italy
Sponsor information
Organisation
G. Moscati Hospital
Sponsor details
Contrada Amoretta
Avellino AV
83100
Italy
+39 (0)825 203426
lucio.zeppa@hotmail.com
Sponsor type
Hospital/treatment centre
Website
Organisation
Dipartimento di Medicina e Scienze per la Salute, Università degli Studi del Molise
Sponsor details
Via F. De Sanctis
1
Campobasso
86100
Italy
+39 (0)874 404 858
dipmedicina@unimol.it
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
31/05/2016
Participant level data
Available on request
Results - basic reporting
Publication summary
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27313871