Minimally invasive combined glaucoma and cataract surgery: clinical results of the smallest ab interno gel stent
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To verify the efficacy in intraocular pressure (IOP) reduction and safety of the smallest gel stent (XEN 45 Gel Stent) microincisional glaucoma surgery combined with microincisional cataract surgery (MICS).
Nonrandomized prospective clinical study. Forty-one eyes of 33 patients with open-angle glaucoma underwent a XEN 45 Gel Stent implantation combined with MICS. Treatment outcomes analyzed included: IOP, medication use, intra- and postoperative complications. At the end of the follow-up, we evaluated the complete success, defined as a postoperative IOP ≥ 6 and ≤17 mmHg without glaucoma medications and the qualified success defined as a postoperative IOP ≥ 6 and ≤17 mmHg, with glaucoma medications.
The mean preoperative IOP was 22.5 ± 3.7 mmHg on 2.5 ± 0.9 medication classes. After 12 months, the mean postoperative IOP was 13.1 ± 2.4 mmHg (mean IOP reduction of 41.82%) with a mean of 0.4 ± 0.8 medication classes (P < 0.05 for IOP and medications). The complete success rate was achieved in 80.4% and a qualified success in 97.5%. There were no major intra- and postoperative complications during the first year of follow-up.
This study demonstrated that the smaller diameter XEN 45 gel implant is statistically effective in reducing IOP and medications in glaucoma patients with a low rate of complications.
KeywordsGlaucoma Microincisional glaucoma surgery (MIGS) XEN Gel Stent Filtration surgery
Compliance with ethical standards
Conflict of interest
The authors declare that they have no conflict of interest.
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 Declaration of Helsinki and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
- 12.Shaarawy T, Sherwood MB, Grehn F (2009) Guidelines on design and reporting of glaucoma surgical trials. Kugler Publications, AmsterdamGoogle Scholar
- 15.Shute TS, Dietrich UM, Dietrich UM, Baker JF, Carmichael KP, Wustenberg W, Ahmed II, Sheybani A (2016) Biocompatibility of a novel microfistula implant in nonprimate mammals for the surgical treatment of glaucoma. Invest Ophthalmol Vis Sci 57(8):3594–3600. doi: 10.1167/iovs.16-19453 CrossRefPubMedGoogle Scholar