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Purpose <p>To 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.</p> Methods <p>Prospective 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.</p> Results <p>Implantation 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.</p> Conclusions <p>The 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.</p> Trial registration <p>ClinicalTrials.gov Identifier: NCT07480603 (retrospectively registered on 17.03.2026).</p>

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

  • 期刊论文

  • 发表日期：

    2026年5月29日

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

摘要

Purpose

To 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.

Methods

Prospective 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.

Results

Implantation 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.

Conclusions

The 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 registration

ClinicalTrials.gov Identifier: NCT07480603 (retrospectively registered on 17.03.2026).