Efficacy and Safety of a Releasable Intraluminal Suture Technique to Reduce Hypotony Following Glaucoma Surgery Using the Preserflo Device

NCT07531199 | Not Yet Recruiting

• 1 other identifier: 2025-26-PDB
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  12 months after surgery

Secondary Outcomes (1)

• Complete surgical success

  12 months after surgery

Study Arms (2)

classical surgery

ACTIVE COMPARATOR

Procedure: Classical surgery

Intraluminal suture

EXPERIMENTAL

Procedure: Intraluminal suture

Interventions

Intraluminal suture PROCEDURE

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.

Intraluminal suture

Classical surgery PROCEDURE

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).

classical surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Privé de la Baie: lead

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Ana Miguel, MD

  Hôpital Privé de la Baie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Mandon, PhD

CONTACT

+33 6 78 27 76 72; mmandon@vivalto-sante.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share