GlaucomaNCT05548959
Outflow Facility AIT vs Microshunt
A study testing Pneumatonometry after microshunt implantation and Pneumatonometry after ab interno trabeculectomy in people with Glaucoma, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Pneumatonometry after microshunt implantation and Pneumatonometry after ab interno trabeculectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2021to 31 Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
- patients suffering from open-angle glaucoma
Who cannot join
- Patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago
- patients suffering from angle-closure glaucoma
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology University Hospital Wuerzburg
Würzburg, Bavaria, 97070
About this study
Official title: Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery
The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.
Read the detailed description
Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.
No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).
In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.
- Conditions
- Glaucoma
- Being tested
- Pneumatonometry after microshunt implantation, Pneumatonometry after ab interno trabeculectomy
- Keywords
- outflow facility, microshunt, ab interno trabeculectomy, pneumatonometer, intraocular pressure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumatonometry after microshunt implantationDiagnostic test
Pneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position.
Pneumatonometry after ab interno trabeculectomyDiagnostic test
Pneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position.
| Study group | Role | What they receive |
|---|---|---|
| Microshunt patients | Experimental | Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation. Receives: Diagnostic Test: Pneumatonometry after microshunt implantation |
| Ab interno trabeculectomy patientes | Experimental | Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy. Receives: Diagnostic Test: Pneumatonometry after ab interno trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure variation
24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.
Measured: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
Secondary outcomes (2)
Outflow facility
Outflow facility of the aqueous humor from the eye obtained by pneumatonography.
Measured: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
Intraocular pressure
Intraocular pressure obtained by the use of a Pneumatonometer
Measured: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Aug 2021
- Primary completion1 Jul 2022
- Study completion31 Jul 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548959
- Sponsor's protocol ID
- 114/21me
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT05548959
- Acronym / sponsor ID
- 114/21me
- Conditions
- Glaucoma
- Keywords
- outflow facility, microshunt, ab interno trabeculectomy, pneumatonometer, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 22 Sep 2022 (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.
The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.
Detailed description
Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.
No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).
In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microshunt patients | Experimental | Diagnostic Test: Pneumatonometry after microshunt implantationPneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation. |
| Ab interno trabeculectomy patientes | Experimental | Diagnostic Test: Pneumatonometry after ab interno trabeculectomyPneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
- patients suffering from open-angle glaucoma
Key exclusion criteria (2 listed)
- Patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago
- patients suffering from angle-closure glaucoma
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 |
|---|---|---|
| Pneumatonometry after microshunt implantationPneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position. | Diagnostic test | Microshunt patients |
| Pneumatonometry after ab interno trabeculectomyPneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position. | Diagnostic test | Ab interno trabeculectomy patientes |
Primary outcome
Intraocular pressure variation
Time frame: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.
2 secondary outcomes
Outflow facility
Time frame: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
Intraocular pressure
Time frame: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
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 22 Sep 2022.
- Deployed Pneumatonometer DeviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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?
A study testing Pneumatonometry after microshunt implantation and Pneumatonometry after ab interno trabeculectomy in people with Glaucoma, run by Wuerzburg University Hospital 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 22 Sep 2022. 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 variation (time frame: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).). 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 22 Sep 2022.