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Twelve-month results of ab interno trabeculectomy with Kahook Dual Blade: an interventional, randomized, controlled clinical study

  • Glaucoma
  • Published:
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Abstract

Purpose

To evaluate the efficacy and safety profile of Kahook Dual Blade ab interno trabeculectomy combined with phacoemulsification compared to stand-alone conventional cataract surgery.

Methods

A single-center longitudinal, randomized controlled trial was conducted. Patients older than 18 years with coexisting cataract and open-angle glaucoma or ocular hypertension were invited to participate. Preoperative and postoperative clinical data were collected and analyzed preoperatively and at months 1, 3, 6, and 12 after the procedure. Main outcome measures included best corrected visual acuity, intraocular pressure, number of glaucoma medications, endothelial cell count, and standard automated perimetry.

Results

Forty-two eyes from 33 patients were randomly allocated to the combined cataract and KDB (treatment, n = 21) or cataract alone (control, n = 21) groups. Intraocular pressure decreased from 17.9 ± 3.5 to 16.0 ± 2.2 mmHg and from 17.3 ± 2.5 to 15 ± 3.2 mmHg at the last visit in the treatment and control groups (p = 0.47). The use of glaucoma medications was reduced from a median (IQR) 1 (1–2) to 0 (0–0) in the treatment group and from 1 (1–2) to 0 (0–1) in the control group, with no significant differences between groups at the 12-month visit (p = 0.47). Best corrected visual acuity, endothelial cell count, and standard automated perimetry remained similar during follow-up in both groups.

Conclusions

In patients with well-controlled, mild-to-moderate glaucoma, adding ab interno trabeculectomy with KDB to phacoemulsification might not be more effective than phacoemulsification alone to reach mid-teens IOP values. Both procedures showed similar safety profiles.

Trial registration

ClinicalTrials.gov Identifier: NCT04202562, December 17, 2019 retrospectively registered

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Data availability

Data are available upon reasonable request. No personal information that could reveal the identity of any of the participants will be transferred.

Code availability

Not applicable.

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Acknowledgements

Presented in part as a poster at the European Glaucoma Society Meeting in Florence, 2018 and as an oral communication at the Spanish Glaucoma Society Congress in Madrid, 2019. The authors would like to extend thanks to Drs. Bárbara Burgos-Blasco, Carlos Narváez-Palazón, and Sara García-Caride for their coordination efforts in this study and to thank Dr. Teresa Valverde-Higueras for assistance in processing of the data.

Author information

Authors and Affiliations

  1. Ophthalmology Department, Instituto de Investigación Sanitaria San Carlos (IdISSC), San Carlos Clinical Hospital, Madrid, Spain

    Néstor Ventura-Abreu, Julián García-Feijoo, Laura Morales-Fernández & José María Martínez-de-la-Casa

  2. Department of Immunology, Ophthalmology and ORL, Faculty of Medicine, Complutense University of Madrid (UCM), Madrid, Spain

    Néstor Ventura-Abreu

  3. OFTARED, Instituto de Investigaciones Oftalmológicas Ramón Castroviejo, Madrid, Spain

    Julián García-Feijoo, Laura Morales-Fernández & José María Martínez-de-la-Casa

  4. Ophthalmology Department, Insitut D’Investigacions Mèdiques August Pi I Sunyer (IDIBAPS), Hospital Clínic de Barcelona, Barcelona University (UB), Barcelona, Spain

    Marta Pazos

  5. Institut de La Màcula, Barcelona Macula Foundation, Barcelona, Spain

    Marc Biarnés

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  1. Néstor Ventura-Abreu
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Contributions

NVA and JGF contributed equally as first authors and wrote the manuscript and interpreted the data; JMMC designed the study protocol; JGF and JMMC equally contributed to patients’ intervention; NVA, JGF, and JMMC ran the trial and drafted sections of the manuscript; LMF assisted with the coordination of the study; NVA, MB, and MP conducted the data analysis, assisted with interpretation of results, and drafted sections of the manuscript; all authors revised the manuscript critically for important intellectual content.

Corresponding author

Correspondence to Néstor Ventura-Abreu.

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Ethics approval

The study was conducted according to the tenets of the Declaration of Helsinki, and ethical approval was obtained from the Human Research Ethics Committee (HREC) of the Hospital Clinico San Carlos, Madrid, Spain (Reference number 16/560_P). This study was registered and approved as a randomized clinical trial: ClinicalTrials.gov Identifier NCT04202562.

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A written informed consent was obtained from each participant of the study. The informed consent allowed publication in peer-reviewed journals.

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The authors declare no competing interests.

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Ventura-Abreu, N., García-Feijoo, J., Pazos, M. et al. Twelve-month results of ab interno trabeculectomy with Kahook Dual Blade: an interventional, randomized, controlled clinical study. Graefes Arch Clin Exp Ophthalmol 259, 2771–2781 (2021). https://doi.org/10.1007/s00417-021-05213-0

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