Evidence map›Paper›PMID 42213132›Full record

ArticleGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2026

First-in-human implantation of a self-adjustable glaucoma drainage device (eyeValve): safety and performance in blind eyes.

Soroush Rafiei, Julien Maxime Gerber, Stéphane Bigler, Adan Villamarin, Constantinos Stergiopulos, Cheikh Ndoye, Elhadji Mbagnick Ngom, André Mermoud, Nikolaos Stergiopulos

Registry-linked trialAbstract read
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In one paragraph

Article in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07480603 (Pilot Study eyeValve), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07480603 phase1active not recruitingnot on this map

Pilot Study eyeValve

TypeinterventionalSponsorRheon Medical SARan2025 to 2026Enrolled10ConditionsGlaucomaArmseyeValve
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Soroush RafieiLaboratory of Hemodynamics and Cardiovascular Technology (LHTC), Swiss Federal Institute of Technology (EPFL), Lausanne, 1015, Switzerland. soroush.rafiei@epfl.ch.
Julien Maxime GerberLaboratory of Hemodynamics and Cardiovascular Technology (LHTC), Swiss Federal Institute of Technology (EPFL), Lausanne, 1015, Switzerland.
Stéphane BiglerLaboratory of Hemodynamics and Cardiovascular Technology (LHTC), Swiss Federal Institute of Technology (EPFL), Lausanne, 1015, Switzerland.
Adan VillamarinRheon Medical SA, EPFL Innovation Park, Building B, Lausanne, Switzerland.
Constantinos StergiopulosRheon Medical SA, EPFL Innovation Park, Building B, Lausanne, Switzerland.
Cheikh NdoyeSwiss Visio Sénégal, Saly, Mbour, Senegal.
Elhadji Mbagnick NgomSwiss Visio Sénégal, Saly, Mbour, Senegal.
André MermoudSwiss Visio Montchoisi, Lausanne, 1006, Switzerland.
Nikolaos StergiopulosLaboratory of Hemodynamics and Cardiovascular Technology (LHTC), Swiss Federal Institute of Technology (EPFL), Lausanne, 1015, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the implantability, safety, and intraocular pressure (IOP)-regulating performance of a novel miniaturized passive self-adjustable glaucoma drainage device (eyeValve) in a first-in-human (FIH) feasibility study.

methodsProspective single-arm pilot study in six blind eyes with end-stage glaucoma and uncontrolled IOP. The eyeValve was implanted in a partial-thickness intrascleral pocket and connected to a distal silicone plate (eyePlate) for orbital drainage. No mitomycin C was used. Follow-up was performed at Day 1, Day 7, Day 28, Day 120, and Month 9. Eyes with transient iris-related tube occlusion were analyzed separately.

resultsImplantation was successful in all eyes. Mean IOP decreased from 30.1 ± 10.6 mmHg to 15.0 ± 7.4 mmHg (Day 1), 12.0 ± 2.0 mmHg (Day 7), 14.8 ± 2.1 mmHg (Day 28), 12.3 ± 2.5 mmHg (Day 120), and 14.3 ± 1.7 mmHg (Month 9), corresponding to an overall reduction of ~ 53%. IOP remained within the physiological range (6-18 mmHg). No hypotony, overdrainage, or sustained postoperative IOP elevation suggestive of bleb encapsulation was observed. Two eyes showed transient iris-related tube occlusion. Among eyes not affected by iris-related tube obstruction, 50% maintained IOP control without glaucoma medication during follow-up.

conclusionsThe eyeValve demonstrated feasibility, safety, and sustained IOP control up to 9 months without hypotony or hypertensive-phase behavior, supporting autonomous pressure regulation. Larger studies are warranted.

trial registrationClinicalTrials.gov Identifier: NCT07480603 (retrospectively registered on 17.03.2026).

Indexed as

Drainage deviceEyeValveFirst-in-humanGlaucomaIntraocular pressureSelf-adjusting valve

Identifiers

PMID42213132

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.