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Contralateral eye comparison study in MICS & MIGS: Trabectome® vs. iStent inject®

  • Glaucoma
  • Published:
Graefe's Archive for Clinical and Experimental Ophthalmology Aims and scope Submit manuscript

Abstract

Purpose

To compare the safety and efficacy profile after combined micro-incision cataract surgery (MICS) and micro-invasive glaucoma surgery (MIGS) with the ab interno trabeculectomy (Trabectome®) in one eye versus two iStent® inject devices in the contralateral eye in patients with open-angle glaucoma (OAG) and cataract.

Methods

This retrospective, intraindividual eye comparison study included 27 patients (54 eyes) who were treated with combined MICS and ab interno trabeculectomy (group I, Trabectome®) in one eye and two iStent® inject devices (group II, GTS 400) in the fellow eye. Primary outcome measures included intraocular pressure (IOP) and glaucoma medication after 6 weeks, 3, 6, and 12 months follow-up. Secondary outcome measures were number of postoperative interventions, complications, and best-corrected visual acuity (BCVA).

Results

Mean preoperative IOP decreased from 22.3 ± 3.7 mmHg in group I and 21.3 ± 4.1 mmHg in group II to 15.6 ± 3.6 mmHg for Trabectome (p < 0.001) and 14.0 ± 2.3 mmHg for iStent inject (p < 0.001) at 12 months after surgery without a significant difference between the two groups (p > 0.05). No vision-threatening complications such as choroidal effusion, choroidal hemorrhage, or infection occurred. In each group trabeculectomy had to be performed in two eyes due to insufficient IOP lowering effect.

Conclusions

Ab interno trabeculectomy and iStent® inject were both effective in lowering IOP with a favourable and comparable safety profile in an intraindividual comparative study over a 12-months follow-up in OAG. However, longer follow-up of these patients will be necessary to determine long-term outcomes and to evaluate significant differences.

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Correspondence to Johannes Gonnermann.

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All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

For this type of study formal consent is not required.

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

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Gonnermann, J., Bertelmann, E., Pahlitzsch, M. et al. Contralateral eye comparison study in MICS & MIGS: Trabectome® vs. iStent inject®. Graefes Arch Clin Exp Ophthalmol 255, 359–365 (2017). https://doi.org/10.1007/s00417-016-3514-8

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  • DOI: https://doi.org/10.1007/s00417-016-3514-8

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