GlaucomaPFLONCT07531199
Efficacy and Safety of a Releasable Intraluminal Suture Technique to Reduce Hypotony Following Glaucoma Surgery Using the Preserflo Device
A study testing Classical surgery and Intraluminal suture in people with Glaucoma, run by Hôpital Privé de la Baie at 1 site in France.
Trial summary
Glaucoma is a common and irreversible disease of the optic nerve. It is the second leading cause of blindness worldwide. Glaucoma can be treated with medication, laser therapy, or surgery; the latter is often necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Classical surgery and Intraluminal suture
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2026to 28 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
- Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with an indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and an open iridocorneal angle (trabeculum visible on gonioscopy, Shaffer classification grade 3-4)
- Healthy, mobile conjunctiva (without scarring or adhesions).
- The indication for glaucoma surgery is defined as uncontrolled IOP or worsening of visual fields despite maximum tolerated medical therapy, and with either a previous failure of trabeculectomy or a risk of failure.
- Maximum tolerated medical therapy: 3 or more classes of ocular hypotensive treatment, or fewer if there is an allergy or intolerance to the treatment. Visual field defects must be more severe than -3 dB in mean deviation.
Who cannot join
- severe systemic pathologies
- other ophtalmic pathologies (except cataract)
- previous intraocular surgery (except cataract)
- neovascular glaucoma or iris neovascularization
- pachymetry < 490µm or > 620µm
- contraindication to PRESERFLO Microshunt
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé de la Baie
Avranches, 50300
Marion Mandon, PhD, +33678277672, drc@vivalto-sante.com
About this study
Glaucoma is a common and irreversible disease of the optic nerve. It is the second leading cause of blindness worldwide. Glaucoma can be treated with medication, laser therapy, or surgery; the latter is often necessary. Traditional surgeries are invasive and carry a high rate of complications (hypotony, endophthalmitis, cataracts, etc.). Consequently, several types of micro-invasive surgeries (MIGS) and less invasive but effective surgeries, LIGS, have been developed to reduce surgical risks while maintaining effectiveness in lowering intraocular pressure (IOP). PRESERFLO is a drainage system less than 1 mm thick that regulates the outflow of aqueous humor from the eye. It is made of a soft, flexible biomaterial that conforms to the curvature of the eye. This biomaterial does not trigger a negative immune response. PRESERFLO is an example of a recently developed, powerful LIGS procedure (with preliminary results demonstrating efficacy and safety). PRESERFLO is already in use in France (marketing authorization and CE marking obtained) and is covered by social security.
This technique is highly effective in lowering IOP, but it may be associated with hypotony, although less frequently than with trabeculectomy. The use of a releasable suture placed inside the Preserflo to limit drainage and, consequently, reduce the risk of hypotony has been described with good results in preliminary studies. Nevertheless, it is necessary to evaluate the efficacy and safety of this technical modification in a randomized, prospective clinical trial to better understand whether this modification is beneficial for improving the treatment of patients with glaucoma.
- Conditions
- Glaucoma
- Being tested
- Classical surgery, Intraluminal suture
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classical surgeryProcedure or surgery
After peritomy, coagulation, and the application of 0.04% mitomycin C (as in a trabeculectomy or any filtration surgery), a scleral tunnel is created 3 mm from the limbus using a 1-mm scalpel designed for this purpose, followed by a 25G needle, which is inserted into the eye parallel to the iris. Next, the Preserflo is inserted into this tunnel, away from the cornea and the iris. The outflow of aqueous humor through the Preserflo is tested by injecting BSS into the anterior chamber. The peritomy is then closed (as in a trabeculectomy).
Intraluminal sutureProcedure or surgery
A 9-0 Ethilon suture is inserted into the distal end of the Preserflo to partially occlude the outflow of aqueous humor through this drain, thereby reducing the risk of postoperative hypotony. The other end of this suture is attached to the cornea, forming a loop (which will allow it to be removed later). Next, the Preserflo and the suture are covered with the Tenon's capsule and the conjunctiva, as in the standard technique.
| Study group | Role | What they receive |
|---|---|---|
| classical surgery | Active comparator | Not described Receives: Procedure: Classical surgery |
| Intraluminal suture | Experimental | Not described Receives: Procedure: Intraluminal suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hypotonia
IOP ≤ 6 mmHg with vision loss, hypotensive maculopathy, or visible choroidal detachment, as determined during two consecutive visits. Intraocular pressure will be measured using Goldman applanation tonometry
Measured: 12 months after surgery
Secondary outcomes (1)
Complete surgical success
It is defined as a reduction in intraocular pressure of at least 20%, without medication, and without a loss of more than 2 lines of visual acuity, major complications, or the need for further glaucoma surgery
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start17 Sep 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Privé de la Baie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Miguel, MD, Principal investigator, Hôpital Privé de la Baie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531199
- Sponsor's protocol ID
- 2025-26-PDB
- Acronym
- PFLO
- Status last verified
- Sep 2026
- First submitted
- 9 Apr 2026
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Releasable Intraluminal Suture Technique to Reduce Hypotony Following Glaucoma Surgery Using the Preserflo Device
- ClinicalTrials.gov ID
- NCT07531199
- Acronym / sponsor ID
- PFLO / 2025-26-PDB
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Hôpital Privé de la BaieUniversity, hospital or other
- Study start
- 17 Sep 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 15 Apr 2026 (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.
Glaucoma is a common and irreversible disease of the optic nerve. It is the second leading cause of blindness worldwide. Glaucoma can be treated with medication, laser therapy, or surgery; the latter is often necessary. Traditional surgeries are invasive and carry a high rate of complications (hypotony, endophthalmitis, cataracts, etc.). Consequently, several types of micro-invasive surgeries (MIGS) and less invasive but effective surgeries, LIGS, have been developed to reduce surgical risks while maintaining effectiveness in lowering intraocular pressure (IOP). PRESERFLO is a drainage system less than 1 mm thick that regulates the outflow of aqueous humor from the eye. It is made of a soft, flexible biomaterial that conforms to the curvature of the eye. This biomaterial does not trigger a negative immune response. PRESERFLO is an example of a recently developed, powerful LIGS procedure (with preliminary results demonstrating efficacy and safety). PRESERFLO is already in use in France (marketing authorization and CE marking obtained) and is covered by social security.
This technique is highly effective in lowering IOP, but it may be associated with hypotony, although less frequently than with trabeculectomy. The use of a releasable suture placed inside the Preserflo to limit drainage and, consequently, reduce the risk of hypotony has been described with good results in preliminary studies. Nevertheless, it is necessary to evaluate the efficacy and safety of this technical modification in a randomized, prospective clinical trial to better understand whether this modification is beneficial for improving the treatment of patients with glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical surgery | Active comparator | Procedure: Classical surgery |
| Intraluminal suture | Experimental | Procedure: Intraluminal suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with an indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and an open iridocorneal angle (trabeculum visible on gonioscopy, Shaffer classification grade 3-4)
Key exclusion criteria (6 listed)
- severe systemic pathologies
- other ophtalmic pathologies (except cataract)
- previous intraocular surgery (except cataract)
- neovascular glaucoma or iris neovascularization
- pachymetry < 490µm or > 620µm
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 |
|---|---|---|
| Classical surgeryAfter peritomy, coagulation, and the application of 0.04% mitomycin C (as in a trabeculectomy or any filtration surgery), a scleral tunnel is created 3 mm from the limbus using a 1-mm scalpel designed for this purpose, followed by a 25G needle, which is inserted into the eye parallel to the iris. Next, the Preserflo is inserted into this tunnel, away from the cornea and the iris. The outflow of aqueous humor through the Preserflo is tested by injecting BSS into the anterior chamber. The peritomy is then closed (as in a trabeculectomy). | Procedure or surgery | classical surgery |
| Intraluminal sutureA 9-0 Ethilon suture is inserted into the distal end of the Preserflo to partially occlude the outflow of aqueous humor through this drain, thereby reducing the risk of postoperative hypotony. The other end of this suture is attached to the cornea, forming a loop (which will allow it to be removed later). Next, the Preserflo and the suture are covered with the Tenon's capsule and the conjunctiva, as in the standard technique. | Procedure or surgery | Intraluminal suture |
Primary outcome
Postoperative hypotonia
Time frame: 12 months after surgery
IOP ≤ 6 mmHg with vision loss, hypotensive maculopathy, or visible choroidal detachment, as determined during two consecutive visits. Intraocular pressure will be measured using Goldman applanation tonometry
1 secondary outcome
Complete surgical success
Time frame: 12 months 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 2 Oct 2026.
- 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.
Ana Miguel, MD principal investigator
Hôpital Privé de la Baie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classical surgery and Intraluminal suture in people with Glaucoma, run by Hôpital Privé de la Baie at 1 site 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 4 inclusion and 6 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 2 Oct 2026. 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 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 Marion Mandon, PhD (+33 6 78 27 76 72, mmandon@vivalto-sante.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hypotonia (time frame: 12 months 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 2 Oct 2026.