In vivo near-infrared fluorescence imaging of aqueous humor outflow structures
| ISRCTN | ISRCTN54005880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54005880 |
| Protocol serial number | N/A |
| Sponsors | G. Moscati Hospital, Dipartimento di Medicina e Scienze per la Salute, Università degli Studi del Molise, Azienda Ospedaliera S.Giuseppe Moscati |
| Funder | Investigator initiated and funded |
- 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
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
Public
Via De Sanctis, 1
Campobasso
86100
Italy
 ORCID ID |
0000-0001-8477-6188 |
|---|---|
| Phone | +39 (0)874 4041 |
| ciro.costagliola@unimol.it |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective open observational single-center pilot study |
| Secondary study design | Case series |
| Study type | 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(s) |
In vivo visualization of the outflow pathway, using the OPMI PENTERO 900 microscope, measured during surgery |
| Key secondary outcome measure(s) |
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 |
| Completion date | 30/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| 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
Italy
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/06/2016: Publication reference added.
