Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13.

Abstract

Purpose: To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary open-angle glaucoma (POAG).

Methods: In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed.

Results: The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were - 6.5 (5.3) mmHg and - 1.7 (1.3) at month 12 and - 6.2 (4.9) mmHg and - 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts.

Conclusions: The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).

Keywords: Ab interno; Glaucoma; Implant; Minimally invasive glaucoma surgery; Stent; XEN.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Antihypertensive Agents / therapeutic use*
  • Female
  • Follow-Up Studies
  • Gelatin / pharmacology*
  • Glaucoma Drainage Implants*
  • Glaucoma, Open-Angle / drug therapy
  • Glaucoma, Open-Angle / physiopathology
  • Glaucoma, Open-Angle / surgery*
  • Humans
  • Intraocular Pressure / physiology*
  • Male
  • Prospective Studies
  • Prosthesis Design
  • Time Factors

Substances

  • Antihypertensive Agents
  • Gelatin

Associated data

  • ClinicalTrials.gov/NCT02006693

Grant support