Open Angle GlaucomaNCT06523751
Trabeculopuncture as Predictive Test for the Success of Ab Interno Trabeculectomy
A study testing Trabeculopuncture in people with Open Angle Glaucoma and Pseudoexfoliation Glaucoma, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Pseudoexfoliation Glaucoma
- What is being tested?
- Trabeculopuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jun 2023to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- individuals ≥ 18 years of age
- clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma
- uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy
- progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p < 0.05)
- progression of visual field defects
- visually significant cataract and indication to reduce IOP or glaucoma medication burden
Who cannot join
- clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma
- prior glaucoma surgery
- preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Uniklinikum Würzburg
Würzburg, Bavaria, 97080
Raoul Verma-Führing, MD, 0049 93120120662, vermafuehr_R@ukw.de
About this study
Official title: Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
The purpose of this study is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.
Read the detailed description
The aim of this study is to develop a non-invasive predictive test for the function of the distal outflow tract after ab interno trabeculectomy for open angle glaucoma. We hypothesize that the ocular pressure drop and outflow change after preoperative trabeculectomy may predict the success of ab interno trabeculectomy. The results of this study should allow trabeculopuncture to be used to select the most appropriate procedure for the individual patient.
- Conditions
- Open Angle Glaucoma, Pseudoexfoliation Glaucoma
- Being tested
- Trabeculopuncture
- Keywords
- Ab Interno Trabeculectomy, Trabeculopuncture, Open Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabeculopunctureDiagnostic test
Trabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork.
| Study group | Role | What they receive |
|---|---|---|
| Trabeculopuncture | Experimental | Individuals undergo neodymium-doped yttrium aluminum garnet (Nd:YAG) trabeculopuncture prior to ab interno trabeculectomy. Receives: Diagnostic Test: Trabeculopuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Intraocular pressure measured by Goldmann applanation tonometry
Measured: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
Outflow facility
Outflow facility is measured by the use of a pneumatonometer
Measured: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
Surgical success
surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops
Measured: at month three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start13 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Open Angle 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Kampik, MD, PhD, Principal investigator, Department of Ophthalmology University Hospital Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523751
- Sponsor's protocol ID
- IRB 113-21-me
- Status last verified
- Apr 2025
- First submitted
- 16 Jul 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Verma-Fuehring R, Dakroub M, Han H, Hillenkamp J, Loewen NA. Trabeculopuncture as a predictive test of distal outflow resistance in canal-based surgery. Sci Rep. 2022 Jun 22;12(1):10584. doi: 10.1038/s41598-022-13990-9.
PubMed 35732782Epstein DL, Melamed S, Puliafto CA, Steinert RF. Neodymium: YAG laser trabeculopuncture in open-angle glaucoma. Ophthalmology. 1985 Jul;92(7):931-7. doi: 10.1016/s0161-6420(85)33932-5.
PubMed 4022580Melamed S, Pei J, Puliafito CA, Epstein DL. Q-switched neodymium-YAG laser trabeculopuncture in monkeys. Arch Ophthalmol. 1985 Jan;103(1):129-33. doi: 10.1001/archopht.1985.01050010135037.
PubMed 3977666Del Priore LV, Robin AL, Pollack IP. Long-term follow-up of neodymium: YAG laser angle surgery for open-angle glaucoma. Ophthalmology. 1988 Feb;95(2):277-81. doi: 10.1016/s0161-6420(88)33195-7.
PubMed 3173993
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
- ClinicalTrials.gov ID
- NCT06523751
- Acronym / sponsor ID
- IRB 113-21-me
- Conditions
- Open Angle Glaucoma, Pseudoexfoliation Glaucoma
- Keywords
- Ab Interno Trabeculectomy, Trabeculopuncture, Open Angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 26 Jul 2024 (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 is to perform trabeculopuncture a test to determine the distal outflow tract function to predict the success of ab interno trabeculectomy.
Detailed description
The aim of this study is to develop a non-invasive predictive test for the function of the distal outflow tract after ab interno trabeculectomy for open angle glaucoma. We hypothesize that the ocular pressure drop and outflow change after preoperative trabeculectomy may predict the success of ab interno trabeculectomy. The results of this study should allow trabeculopuncture to be used to select the most appropriate procedure for the individual patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Determining Distal Outflow Tract Function in Open Angle Glaucoma as a Predictive Test for the Success of Ab Interno Trabeculectomy
| Arm | Type | Receives |
|---|---|---|
| Trabeculopuncture | Experimental | Diagnostic Test: TrabeculopunctureIndividuals undergo neodymium-doped yttrium aluminum garnet (Nd:YAG) trabeculopuncture prior to 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 (6 listed)
- individuals ≥ 18 years of age
- clinical diagnosis of: primary open angle glaucoma, pigmentary glaucoma, or pseudoexfoliation glaucoma
- uncontrolled intraocular pressure (IOP) with maximally tolerated medical therapy
- progressive thinning of retinal nerve fiber layer assessed by Spectral domain optical coherence tomography (p < 0.05)
- progression of visual field defects
Key exclusion criteria (3 listed)
- clinical diagnosis of neovascular glaucoma, angle-closure glaucoma, uveitic glaucoma, neovascular glaucoma
- prior glaucoma surgery
- preexisting conditions affecting the episcleral venous pressure including Grave's ophthalmopathy, Sturge-Weber syndrome, Arteriovenous fistulas (carotid-cavernous fistula)
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 |
|---|---|---|
| TrabeculopunctureTrabeculopuncture is performed with a Nd:YAG laser on the trabecular meshwork. Four punctures are created along the 180° nasal trabecular meshwork. | Diagnostic test | Trabeculopuncture |
Primary outcome
IOP
Time frame: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
Intraocular pressure measured by Goldmann applanation tonometry
Outflow facility
Time frame: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively
Outflow facility is measured by the use of a pneumatonometer
Surgical success
Time frame: at month three
surgical success at month three is defined as 20% IOP reduction without increasing the number of glaucoma drops
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 35732782Verma-Fuehring R, Dakroub M, Han H, Hillenkamp J, Loewen NA. Trabeculopuncture as a predictive test of distal outflow resistance in canal-based surgery. Sci Rep. 2022 Jun 22;12(1):10584. doi: 10.1038/s41598-022-13990-9.
- Background: PubMed 4022580Epstein DL, Melamed S, Puliafto CA, Steinert RF. Neodymium: YAG laser trabeculopuncture in open-angle glaucoma. Ophthalmology. 1985 Jul;92(7):931-7. doi: 10.1016/s0161-6420(85)33932-5.
- Background: PubMed 3977666Melamed S, Pei J, Puliafito CA, Epstein DL. Q-switched neodymium-YAG laser trabeculopuncture in monkeys. Arch Ophthalmol. 1985 Jan;103(1):129-33. doi: 10.1001/archopht.1985.01050010135037.
- Background: PubMed 3173993Del Priore LV, Robin AL, Pollack IP. Long-term follow-up of neodymium: YAG laser angle surgery for open-angle glaucoma. Ophthalmology. 1988 Feb;95(2):277-81. doi: 10.1016/s0161-6420(88)33195-7.
- 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.
Daniel Kampik, MD, PhD principal investigator
Department of Ophthalmology University Hospital Würzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trabeculopuncture in people with Open Angle Glaucoma and Pseudoexfoliation 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raoul Verma-Fuehring, MD (+49 93120120662, vermafuehr_R@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: before and two hours after trabeculopuncture, one and four weeks postoperatively (after ab interno trabeculectomy), and three months postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06523751, which also lists 4 linked publications.
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 3 Apr 2025.