GlaucomaNCT01741961
Long Term Outcome After Ahmed Glaucoma Valve
An observational study of Glaucoma, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Ahmed valve
- Type of treatment
- Surgery or procedure
- How many people
- 214 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Oct 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from uncontrolled glaucoma, most often after multiple ocular surgery.
Who may be able to join
- Patients suffering from medically uncontrolled glaucoma
- Informed consent
Who cannot join
- healthy subjects
- under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma
Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.
Read the detailed description
The development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after Ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.
- Conditions
- Glaucoma
- Being tested
- Ahmed valve
- Keywords
- uncontrolled glaucoma, glaucoma drainage device
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ahmed valveProcedure or surgery
The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma.
| Study group | Role | What they receive |
|---|---|---|
| glaucoma, surgery, Ahmed valve | Patients with uncontrolled glaucoma undergoing Ahmed glaucoma valve implantation for intraocular pressure reduction. Receives: Procedure: Ahmed valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure reduction
The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years.
Measured: 4 years
Secondary outcomes (1)
development of visual acuity
The development of visual acuity after Ahmed glaucoma valve implantation is being examined over a period of 4 years.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startJun 2006
- Primary completionOct 2012
- Study completionOct 2012
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Karin Pillunat, Technische Universität Dresden
- Investigators
- Karin R Pillunat, MD, Principal investigator, University Dresden, Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741961
- Sponsor's protocol ID
- Ahmed-LTO
- Status last verified
- Dec 2012
- First submitted
- 22 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma
- ClinicalTrials.gov ID
- NCT01741961
- Acronym / sponsor ID
- Ahmed-LTO
- Conditions
- Glaucoma
- Keywords
- uncontrolled glaucoma, glaucoma drainage device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Dec 2012 (estimated)
- 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.
Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.
Detailed description
The development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after Ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glaucoma, surgery, Ahmed valve | – | Procedure: Ahmed valvePatients with uncontrolled glaucoma undergoing Ahmed glaucoma valve implantation for intraocular pressure reduction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from uncontrolled glaucoma, most often after multiple ocular surgery.
Key inclusion criteria (2 listed)
- Patients suffering from medically uncontrolled glaucoma
- Informed consent
Key exclusion criteria (2 listed)
- healthy subjects
- under 18 years
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 |
|---|---|---|
| Ahmed valveThe flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma. | Procedure or surgery | glaucoma, surgery, Ahmed valve |
Primary outcome
intraocular pressure reduction
Time frame: 4 years
The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years.
1 secondary outcome
development of visual acuity
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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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.
Karin R Pillunat, MD principal investigator
University Dresden, Eye Clinic
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 Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2012. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
intraocular pressure reduction (time frame: 4 years). 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 5 Dec 2012.