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Efficacy and safety of the PreserFlo implant with mitomycin C in childhood glaucoma after previous failed glaucoma surgeries

  • Glaucoma
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Abstract

Purpose

This study aims to evaluate the efficacy and safety of the PreserFlo MicroShunt (Santen, Osaka, Japan) in lowering intraocular pressure (IOP) in childhood glaucoma patients with previous failed glaucoma surgeries.

Methods

This is a prospective case review of consecutive PreserFlo procedures performed in childhood glaucoma patients after failed surgeries. Age, sex, diagnosis, and previous glaucoma surgeries, as well as visual acuity, IOP, and treatment in the preoperative visit and all follow-up visits were collected. Outcome measures included IOP reduction from baseline, mean IOP change from baseline at month 6, medication use at 6 months, complications, adverse events, and need for further procedures.

Results

Fourteen patients were included, 8 (57%) males and 6 (43%) females; the mean age was 27.5 ± 13.5 years. Nine patients (64%) had at least two trabeculectomies, and 6 patients (43%) had at least one trabeculectomy and a glaucoma drainage implant. The mean IOP change from baseline was 11.3 ± 4.9 mmHg at 12 months. At 12 months, 12 patients (86%) presented ≥ 20% IOP lowering from baseline, and 11 patients (79%) presented ≥ 30%. The mean medication count decreased from 3.9 ± 0.7 (baseline) to 0.7 ± 1.3 (12 months). No intraoperative complications were reported. No adverse events were noted. No secondary filtration surgery was required, although bleb needling was required in one case, 1 month after the surgery.

Conclusions

PreserFlo with MMC can be used successfully to treat uncontrolled IOP in childhood glaucoma cases with previous failed surgeries. Larger studies with longer follow-up are needed to further explore the role of the device in resistant childhood glaucoma cases.

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Authors and Affiliations

  1. Servicio de Oftalmología, Instituto de Investigación Sanitaria, Hospital Clínico San Carlos (IdISSC), Hospital Clinico San Carlos, Madrid, Spain

    Barbara Burgos-Blasco, Julian García-Feijóo, Cristina Gines-Gallego, Lucía Perucho-Gonzalez, Jose Ignacio Fernandez-Vigo, Jose María Martinez de la Casa, Federico Saenz-Frances, Laura Morales-Fernandez & Carmen Dora Mendez-Hernandez

  2. Departamento de Inmunología, Oftalmología Y ORL, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain

    Julian García-Feijóo & Jose María Martinez de la Casa

Authors
  1. Barbara Burgos-Blasco
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  2. Julian García-Feijóo
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  3. Cristina Gines-Gallego
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  4. Lucía Perucho-Gonzalez
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  5. Jose Ignacio Fernandez-Vigo
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  6. Jose María Martinez de la Casa
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  7. Federico Saenz-Frances
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  8. Laura Morales-Fernandez
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Corresponding author

Correspondence to Barbara Burgos-Blasco.

Ethics declarations

Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the Hospital Clinico San Carlos, with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards and approved by the Hospital Clinico San Carlos Committee.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Conflict of interest

B Burgos-Blasco, C Gines-Gallego, L Perucho-Gonzalez, Federico Saenz-Frances, L Morales-Fernandez, and CD Mendez-Hernandez have participated as coinvestigators in studies regarding the PreserFlo implant promoted by Santen.

J Garcia-Feijoo has received research funding from Santen, Allergan, Glaukos, Alcon, AJL, Thea, Sight Science, Heidelberg, J&J, B&L, Pfizer, Zeiss, Ivantis, and iStar and is Advisory Board of Santen, Alcon, Allergan, Alimera, Thea, Glaukos, and iStar.

JM Martinez de la Casa has received research funding from Santen, Ivantis, Allergan, Pfizer, Glaukos, and Thea; is advisory boards of Allergan, Santen, Alcon, Pfizer, Novartis, Thea, B&L, Glaukos, AJL, and Visufarma; and is a Speaker for Allergan, Santen, Alcon, Pfizer, Novartis, Thea, B&L, Glaukos, and ICare.

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Burgos-Blasco, B., García-Feijóo, J., Gines-Gallego, C. et al. Efficacy and safety of the PreserFlo implant with mitomycin C in childhood glaucoma after previous failed glaucoma surgeries. Graefes Arch Clin Exp Ophthalmol 261, 1349–1357 (2023). https://doi.org/10.1007/s00417-022-05939-5

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  • DOI: https://doi.org/10.1007/s00417-022-05939-5

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