Condition category
Eye Diseases
Date applied
05/02/2016
Date assigned
12/02/2016
Last edited
20/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.aosgmoscati.av.it/

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

http://dipmedicina.unimol.it/il-dipartimento/

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

Publication citations

Additional files

Editorial Notes

20/06/2016: Publication reference added.