In vivo near-infrared fluorescence imaging of aqueous humor outflow structures

ISRCTN	ISRCTN54005880
DOI	https://doi.org/10.1186/ISRCTN54005880
Secondary identifying numbers	N/A

Submission date: 05/02/2016
Registration date: 12/02/2016
Last edited: 20/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Prof Ciro Costagliola
Public

Via De Sanctis, 1
Campobasso
86100
Italy

ORCID ID	0000-0001-8477-6188
Phone	+39 (0)874 4041
Email	ciro.costagliola@unimol.it

Study information

Study design	Prospective open observational single-center pilot study
Primary study design	Observational
Secondary study design	Case series
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	In vivo near-infrared fluorescence imaging of aqueous humor outflow structures: a prospective, open, observational single center pilot study
Study objectives	To visualize the aqueous outflow system in patients affected by primary open angle glaucoma that have undergone canaloplasty.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	30/05/2015
Completion date	30/11/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Ten patients
Key inclusion criteria	Adult patients affected by POAG undergoing canaloplasty
Key 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
Date of first enrolment	30/05/2015
Date of final enrolment	30/09/2015

Locations

Countries of recruitment

Italy

Study participating centres

San Giuseppe Moscati Hospital

83100
Italy

University of Molise

86100
Italy

Sponsor information

G. Moscati Hospital
Hospital/treatment centre

Contrada Amoretta
Avellino AV
83100
Italy

Phone	+39 (0)825 203426
Email	lucio.zeppa@hotmail.com
Website	http://www.aosgmoscati.av.it/

Dipartimento di Medicina e Scienze per la Salute, Università degli Studi del Molise
University/education

Via F. De Sanctis, 1
Campobasso
86100
Italy

Phone	+39 (0)874 404 858
Email	dipmedicina@unimol.it
Website	http://dipmedicina.unimol.it/il-dipartimento/

Azienda Ospedaliera S.Giuseppe Moscati
Not defined

Website	http://www.aosgmoscati.av.it/
"ROR"	https://ror.org/021jxzw96

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/05/2016
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2016		Yes	No

Editorial Notes

20/06/2016: Publication reference added.