124
Views
4
CrossRef citations to date
0
Altmetric
Clinical Trial Report

Treatment of Open-Angle Glaucoma with iStent Implantation Combined with Phacoemulsification in Polish Caucasian Population

ORCID Icon, ORCID Icon, ORCID Icon & ORCID Icon
Pages 473-480 | Published online: 10 Feb 2021
 

Abstract

Purpose

The aim of this investigation was to evaluate the impact of iStent (the first-generation trabecular bypass) implantation with phacoemulsification on the intraocular pressure (IOP) and glaucoma medication in subjects with mild to moderate open-angle glaucoma (OAG) and cataract in a Polish Caucasian population.

Patients and Methods

This prospective case series covered 78 eyes of (57 Polish Caucasian patients) that had undergone iStent implantation in conjunction with cataract surgery. Patients were surveyed preoperatively and at postoperative day 1, week 1, and months 1, 3, 6, 12, and 24. Pre- and postoperative outcome measurements included visual acuity, IOP, and medication burden. Intraoperative and postoperative complications were noted for the safety profile. For effective treatment, an IOP reduction ≥20% was assumed, regardless of the use of IOP-lowering drops. Complete surgical success was defined as an IOP ≤ 15 mmHg, medications free, and a qualified surgical success as IOP ≤ 15 mmHg with or without medications.

Results

Post-operatively at two years, mean IOP reduced from 18.5 mmHg to 16.1 mmHg. The mean medication burden dropped from 1.8 to 0.4 at the end of follow-up. Preoperatively, 2 (2.6%) eyes were medication free, but by postoperative month 24, 53 (68%) eyes were medication-free (p < 0.05). Effective treatment was achieved in 50 cases (64%) at the end of follow-up period. Kaplan–Meier cumulative incidence of qualified success was 51.9% after 24 months, CI95 [41.9%; 64.4%], while cumulative incidence of complete success after 2 years of observation was 35.1%, CI95 [25.9%; 47.5%].

Conclusion

The iStent device combined with a cataract surgery served to decrease, significantly and positively, both IOP and medication use in the 24-months follow-up in patients with coexistent OAG and cataract in Polish patients.

Data Sharing Statement

All the materials and information will be available upon an e-mail request to the corresponding author. Names and exact data of the participants of the study may not be available owing to patient confidentiality and privacy policy.

Ethics Approval and Informed Consent

This study was performed in line with the principles of the Declaration of Helsinki. The protocol was approved by the Bioethics Committee at the Military Institute of Medicine. Written informed consent to participate in the study for at least 24 months was sought from all patients.

Consent for Publication

The participants have consented for the submission of results of the study to the journal.

Acknowledgments

We would like to thank Editage for English language editing.

Author Contributions

MK worked on the main text and worked on figures. JK worked on the main text. ZM worked on the main text. MR operated the patients and worked on the main text. All authors contributed to data analysis, drafting or revising the article, have agreed on the journal to which the article will be submitted, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.