GlaucomaNCT03850054
AADI Glaucoma Shunt - a Quality Control Study
An observational study of Glaucoma, run by Odense University Hospital at 1 site in Denmark.
Trial summary
To prospectively investigate the effect and safety of implantation of the AADI glaucoma tube in eyes with medically intractable glaucoma in the period 2019 to 2020, at the Department of Ophthalmology, Odense University Hospital. The device will be implanted in eyes instead of the Bearveldt drainage device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- What is being tested?
- AADI glaucoma shunt
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Mar 2019to 8 Sep 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Observational study, prospective, to evaluate the effect and safety of this new drainage device
Patients referred to glaucoma shunt implant (Baerveldt) will recieve the AADI glaucoma shunt
Trial locations and contacts
1 site in 1 country.
About this study
To prospectively investigate the effect and safety of implantation of the AADI glaucoma tube in eyes with medically intractable glaucoma in the period 2019 to 2020, at the Department of Ophthalmology, Odense University Hospital.
The device will be implanted in eyes instead of the Bearveldt drainage device. Patients and data are prospectively registered to evaluate the effect and safety of the AADI device.
- Conditions
- Glaucoma
- Being tested
- AADI glaucoma shunt
- Keywords
- AADI; glaucoma tube shunt
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AADI glaucoma shuntProcedure or surgery
Implantation of the nonvalved AADI glaucoma shunt instead of the Bearveldt tube shunt, in eyes with intractable glaucoma.
It is not a RCT study, but a prospective evaluation of the AADI device, and the study has been approved as a quality control study at the Department of Ophthalmology, at Odense University Hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IOP
Intraocular pressure before and after surgery
Measured: Baseline and after 12 months
The change in number of IOP lowering drugs
Number of IOP lowering drugs before and after the surgery
Measured: Baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start4 Mar 2019
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Why it stopped: No further use of the divice at our department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders H. Vestergaard, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850054
- Sponsor's protocol ID
- 19/7009
- Status last verified
- Oct 2023
- First submitted
- 4 Feb 2019
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be deleted after use, as according to regulation
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AADI Glaucoma Shunt - a Quality Control Study
- ClinicalTrials.gov ID
- NCT03850054
- Acronym / sponsor ID
- 19/7009
- Conditions
- Glaucoma
- Keywords
- AADI; glaucoma tube shunt
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No further use of the divice at our department
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively investigate the effect and safety of implantation of the AADI glaucoma tube in eyes with medically intractable glaucoma in the period 2019 to 2020, at the Department of Ophthalmology, Odense University Hospital.
The device will be implanted in eyes instead of the Bearveldt drainage device. Patients and data are prospectively registered to evaluate the effect and safety of the AADI device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Observational study, prospective, to evaluate the effect and safety of this new drainage device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AADI glaucoma shuntImplantation of the nonvalved AADI glaucoma shunt instead of the Bearveldt tube shunt, in eyes with intractable glaucoma. It is not a RCT study, but a prospective evaluation of the AADI device, and the study has been approved as a quality control study at the Department of Ophthalmology, at Odense University Hospital | Procedure or surgery | – |
Primary outcome
Change in IOP
Time frame: Baseline and after 12 months
Intraocular pressure before and after surgery
The change in number of IOP lowering drugs
Time frame: Baseline and after 12 months
Number of IOP lowering drugs before and after the surgery
Results and safety
The study was stopped early (reason given: No further use of the divice at our department). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No. data will be deleted after use, as according to regulation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No further use of the divice at our department). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IOP (time frame: Baseline and after 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.