New surgical procedure for implantation of glaucoma drainage tubes behind the iris
| ISRCTN | ISRCTN14276553 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14276553 |
| EudraCT/CTIS number | 2019-001852-20 |
| Secondary identifying numbers | 65 |
- Submission date
- 19/04/2019
- Registration date
- 31/05/2019
- Last edited
- 26/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Glaucoma drainage devices (GDD) are frequently implanted in patients with glaucoma, most of the tube is implanted in the anterior chamber. However, this implantation causes problems in the cornea. To avoid this, many surgeons implant tubes in the posterior chamber (between the iris and the intraocular lens), although this is cumbersome and a more difficult surgical technique. In this study, a new method of inserting the tube was investigated for safety.
Who can participate?
Patients with glaucoma who require GDD tube implantation.
What does the study involve?
The study consists of teaching an easy, simple and effective method to implant GDD tubes in the posterior chamber. This surgical technique was designed and published by us about 10 years ago but is now modified.
What are the possible benefits and risks of participating?
The main benefits are to facilitate the surgical technique, shorten the time of the surgery and avoid intra and postoperative complications. The risks are scarce and not due to the surgical manoeuvre but to the evolution of glaucoma.
Where is the study run from?
Clínica Universidad de Navarra, Pamplona, Spain.
When is the study starting and how long is it expected to run for?
January 2009 to January 2019.
Who is funding the study?
Universidad de Navarra, Spain.
Who is the main contact?
Prof. Javier Moreno-Montañés,
jmoreno@unav.es
Contact information
Scientific
Clinica Universidad De Navarra
Avenida Pío XII 36
Pamplona
31008
Spain
 ORCID ID |
0000-0002-6623-6783 |
|---|---|
| Phone | 34-948 255 400 |
| jmoreno@unav.es |
Study information
| Study design | Retrospective study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Surgical study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Surgical technique for ab interno implantation of glaucoma drainage devices (GDD) in the posterior chamber in patients with glaucoma |
| Study acronym | NSTAIIGDDTPC |
| Study objectives | The hypothesis of our study is that it is easier and more comfortable for a surgeon to insert a tube behind the iris (therefore without direct vision) by traction of the tube from inside the eye through a prolene suture compared to the usual method. |
| Ethics approval(s) | Study approved by the ethical committee of the University of Navarra (Edificio Central, Campus universitario, 31009 Pamplona, Navarra, Spain; +34 948296500; ceic@unav.es), ref: 2019.062 |
| Health condition(s) or problem(s) studied | Glaucoma |
| Intervention | Implantation of the glaucoma drainage tube into the posterior chamber using a 10/0 prolene needle. The new technique begins with the passage of one of two straight needles existing at each end of a 10-0 Polypropylene suture through the GDD tube. A 23-gauge needle then is inserted at an angle 180° away and passed from the anterior to the posterior chamber and finally through the sclera. The two suture straight needles from the 10-0 Polypropylene suture are positioned in the lumen of the 23-gauge needle. The 23-gauge needle is then extracted from the eye by passing the 2 needles through the lumen. The suture remains inside the posterior chamber, and the tube is inserted into the posterior chamber by pulling on the suture from the other side. The participants included in this study were patients who had to be operated on for glaucoma surgery using a Glaucoma Drainage Device (GDD). They were therefore patients with glaucoma with a surgical indication. These patients signed informed consent. The duration of the follow-up was as long as possible until the study was prepared for publication. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Adequate and correct placement of the tube and ease of surgical technique assessed by the surgeon who performed the operation one day after the procedure. |
| Secondary outcome measures | 1. Intraocular pressure control after the follow-up period measured at all postoperative visits with a Goldmann tonometer. 2. Presence of complications following surgery. |
| Overall study start date | 01/01/2009 |
| Completion date | 01/01/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | Patients with advanced glaucoma who have undergone drainage device implantation |
| Key exclusion criteria | 1.Cataract surgery |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 01/01/2019 |
Locations
Countries of recruitment
- Spain
Study participating centre
Pamplona
31008
Spain
Sponsor information
Hospital/treatment centre
Avenida Pío XII
Pamplona
31008
Spain
| Phone | +34 606560611 |
|---|---|
| jmoreno@unav.es | |
| Website | https://www.cun.es/ |
"ROR" |
https://ror.org/03phm3r45 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Navarra
- Location
- Spain
Results and Publications
| Intention to publish date | 05/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Publication in BMC Ophthalmology as a Technical Advance |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/02/2020 | 26/10/2020 | Yes | No |
Editorial Notes
The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/06/2019: Internal review.
28/05/2019: Trial’s existence confirmed by the ethical committee of the University of Navarra.
