Glaucoma, Open Angle, Pseudo-exfoliativeNCT06979752
Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
A study testing Tran canula and augmented irrigation in people with Glaucoma, Open Angle, Pseudo-exfoliative and Cataract, run by Hôpital Privé de la Baie at 3 sites in France.
Trial summary
Pseudoexfoliative glaucoma is a glaucoma secondary to pseudoexfoliative syndrome; cataract surgery is often more difficult, with more complications. Tran's cannula is a single-use irrigation system designed for cleaning, with the pseudoexfoliative material remaining in the trabecular meshwork. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open Angle, Pseudo-exfoliative, Cataract
- What is being tested?
- Tran canula and augmented irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 3 sitesFrance
- Study dates
- 4 Jun 2025to 2 Feb 2029
- 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
- Patients with cataract and early-to-moderate pseudoexfoliative glaucoma (GPX) scheduled for isolated cataract surgery.
- Reliable visual field, Humphrey 24-2, Sita-Fast, with typical glaucoma alterations, and with mean deviation ≤-12 dB.
- OCT with ganglion cell alterations and fibers typical of glaucoma.
- Typical glaucomatous neuropathy
- Slit-lamp signs of pseudoexfoliation.
- Open angle (2 to 4, according to Shaffer classification) determined by gonioscopy.
- Untreated eye pressure >21 mmHg and <33 mmHg
Who cannot join
- Presence of other ophthalmological pathologies (except cataract or mild dry eye)
- History of intraocular surgery in the last 12 months, history of trauma
- History of laser trabeculoplasty (TLA or SLT) in the previous 12 months
- Visual acuity below "finger count
- Myopia ≥ 6 dioptres, hyperopia ≥ 5 dioptres
- Iridocorneal angle closure (and angle-closure glaucoma), any other type of non-pseudoexfoliative glaucoma, iris neovascularization
- Pachymetry < 490 μm or > 620 μm; or corneal pathology or other condition that makes accurate IOP measurements with flattening tonometry, ultrasonic pachymetry or specular microscopy impossible.
- Presence of severe systemic pathologies
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 2 recruiting
- Recruiting
Hôpital Privé de la Baie
Avranches
- Active, not recruiting
Fondation Rothschild
Paris
- Not yet recruiting
Clinique de la Côte d'Emeraude
St-Malo, 35400
Marion Mandon, PhD, +336 78 27 76 72, mmandon@vivalto-sante.com
About this study
Pseudoexfoliative glaucoma is a glaucoma secondary to pseudoexfoliative syndrome; cataract surgery is often more difficult, with more complications. Tran's cannula is a single-use irrigation system designed for cleaning, with the pseudoexfoliative material remaining in the trabecular meshwork.
The main objective of this study is to evaluate the efficacy of the Tran cannula, in comparison with increased irrigation, in lowering intraocular pressure (IOP) in patients with pseudoexfoliative glaucoma and treated for glaucoma, and with an indication for isolated cataract surgery.
- Conditions
- Glaucoma, Open Angle, Pseudo-exfoliative, Cataract
- Being tested
- Tran canula, augmented irrigation
- Medical subject headings
- Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tran canulaProcedure or surgery
After phacoemulsification, implantation of the intraocular implant and aspiration of the viscoelastic, we connect the TranCanula® to the irrigation system. Then we treat the trabecular mesh.
augmented irrigationProcedure or surgery
After phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh.
| Study group | Role | What they receive |
|---|---|---|
| Tran cannula surgery | Experimental | Patients treated with Tran cannula Receives: Procedure: Tran canula |
| augmented irrigation surgery | Active comparator | Patients treated with augmented irrigation cannula. Receives: Procedure: augmented irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure measure
Measured: day 1, day 30, month 3, month 6 and month 12 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start4 Jun 2025
- Primary completion2 Feb 2028 (estimated)
- Study completion2 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open Angle, Pseudo-exfoliativeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé de la Baie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979752
- Sponsor's protocol ID
- 2023-23-PDB
- Status last verified
- Sep 2026
- First submitted
- 12 May 2025
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation
- ClinicalTrials.gov ID
- NCT06979752
- Acronym / sponsor ID
- 2023-23-PDB
- Conditions
- Glaucoma, Open Angle, Pseudo-exfoliative, Cataract
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Hôpital Privé de la BaieUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 2 Feb 2029 (estimated)
- First posted
- 20 May 2025 (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.
Pseudoexfoliative glaucoma is a glaucoma secondary to pseudoexfoliative syndrome; cataract surgery is often more difficult, with more complications. Tran's cannula is a single-use irrigation system designed for cleaning, with the pseudoexfoliative material remaining in the trabecular meshwork.
The main objective of this study is to evaluate the efficacy of the Tran cannula, in comparison with increased irrigation, in lowering intraocular pressure (IOP) in patients with pseudoexfoliative glaucoma and treated for glaucoma, and with an indication for isolated cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tran cannula surgery | Experimental | Procedure: Tran canulaPatients treated with Tran cannula |
| augmented irrigation surgery | Active comparator | Procedure: augmented irrigationPatients treated with augmented irrigation cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with cataract and early-to-moderate pseudoexfoliative glaucoma (GPX) scheduled for isolated cataract surgery.
- Reliable visual field, Humphrey 24-2, Sita-Fast, with typical glaucoma alterations, and with mean deviation ≤-12 dB.
- OCT with ganglion cell alterations and fibers typical of glaucoma.
- Typical glaucomatous neuropathy
- Slit-lamp signs of pseudoexfoliation.
Key exclusion criteria (8 listed)
- Presence of other ophthalmological pathologies (except cataract or mild dry eye)
- History of intraocular surgery in the last 12 months, history of trauma
- History of laser trabeculoplasty (TLA or SLT) in the previous 12 months
- Visual acuity below "finger count
- Myopia ≥ 6 dioptres, hyperopia ≥ 5 dioptres
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 |
|---|---|---|
| Tran canulaAfter phacoemulsification, implantation of the intraocular implant and aspiration of the viscoelastic, we connect the TranCanula® to the irrigation system. Then we treat the trabecular mesh. | Procedure or surgery | Tran cannula surgery |
| augmented irrigationAfter phacoemulsification, We use the classical aspiration cannula to irrigate the trabecular mesh. | Procedure or surgery | augmented irrigation surgery |
Primary outcome
Intraocular pressure measure
Time frame: day 1, day 30, month 3, month 6 and month 12 after surgery
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 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open Angle, Pseudo-exfoliative
RecruitingObservational study
Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options
Glaucoma Eye, Open-angle Glaucoma
RecruitingObservational study
Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt
Glaucoma, Open Angle Glaucoma (OAG)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tran canula and augmented irrigation in people with Glaucoma, Open Angle, Pseudo-exfoliative and Cataract, run by Hôpital Privé de la Baie at 3 sites in France.
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 7 inclusion and 8 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 Ana Miguel, MD (+33 7 87 01 61 87, myworld_ana@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure measure (time frame: day 1, day 30, month 3, month 6 and month 12 after surgery). 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 30 Sep 2026.