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

Conditions

• Glaucoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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).
• 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.

Study Details

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.

Key Dates

First listed

Apr 15, 2026

Start date

May 1, 2026

Status verified

Apr 2026

Primary completion

Dec 31, 2028

Completion

Feb 28, 2029

Study Design

Enrollment

192 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: classical surgery
• Experimental: Intraluminal suture

Primary Outcome Measure

Postoperative hypotonia [ Time Frame: 12 months after surgery ]

Central Contacts

• Marion Mandon, PhD
  +33 6 78 27 76 72
  [email protected]

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