Condition category
Eye Diseases
Date applied
19/04/2019
Date assigned
31/05/2019
Last edited
07/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Javier Moreno-Montañés

ORCID ID

http://orcid.org/0000-0002-6623-6783

Contact details

Clinica Universidad De Navarra
Avenida Pío XII 36
Pamplona
31008
Spain
34-948 255 400
jmoreno@unav.es

Additional identifiers

EudraCT number

2019-001852-20

ClinicalTrials.gov number

Nil known

Protocol/serial number

65

Study information

Scientific title

Surgical technique for ab interno implantation of glaucoma drainage devices (GDD) in the posterior chamber in patients with glaucoma

Acronym

NSTAIIGDDTPC

Study hypothesis

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

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

Study design

Retrospective study

Primary study design

Observational

Secondary study design

Surgical study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/01/2009

Overall trial end date

01/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients with advanced glaucoma who have undergone drainage device implantation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

1.Cataract surgery

Recruitment start date

01/02/2009

Recruitment end date

01/01/2019

Locations

Countries of recruitment

Spain

Trial participating centre

Clínica Universidad de Navarra
Avenida Pío XII, 36
Pamplona
31008
Spain

Sponsor information

Organisation

Clínica Universidad de Navarra

Sponsor details

Avenida Pío XII
Pamplona
31008
Spain
+34 606560611
jmoreno@unav.es

Sponsor type

Hospital/treatment centre

Website

https://www.cun.es/

Funders

Funder type

University/education

Funder name

Universidad de Navarra

Alternative name(s)

University of Navarra

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Spain

Results and Publications

Publication and dissemination plan

Publication in BMC Ophthalmology as a Technical Advance

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

05/05/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2019: Internal review. 28/05/2019: Trial’s existence confirmed by the ethical committee of the University of Navarra.