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Clin Exp OphthalmolJune 201742 citations

Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up.

Berdahl John, Voskanyan Lilit, Myers Jonathan S, Hornbeak Dana M, Giamporcaro Jane Ellen, Katz L Jay, Samuelson Thomas W


AI Summary

This study found that two trabecular stents plus one postoperative eye drop significantly lowered intraocular pressure (to ≤13 mmHg) and reduced medication burden safely for 18 months in open-angle glaucoma patients.

Abstract

Importance

Additional data are sought regarding treatment options for glaucoma, a major cause of global blindness.

Background

The study assessed outcomes following standalone implantation of two second-generation trabecular micro-bypass stents and postoperative topical prostaglandin in eyes with open-angle glaucoma not controlled on two preoperative medications.

Design

The study design is a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre.

Participants

Subjects had open-angle glaucoma with preoperative intraocular pressure of 18-30 mmHg on two medications, a medication washout phase, and post-washout intraocular pressure of 22-38 mmHg. All subjects (N = 53) have been followed for 18 months.

Methods

One day following implantation of two second-generation trabecular micro-bypass stents, subjects started topical travoprost. Medication washout was repeated at month 12.

Main outcome measures

The main outcome measure was the proportion of eyes with intraocular pressure reduction ≥ 20% versus medicated baseline intraocular pressure with reduction of one medication at 12 months.

Results

At 12 months, 91% of eyes achieved intraocular pressure reduction ≥ 20% with reduction of one medication. All eyes had intraocular pressure ≤ 18 mmHg with reduction of one medication, and 87% had intraocular pressure ≤ 15 mmHg. Mean intraocular pressure on one medication was ≤ 13.0 mmHg (≥ 34% reduction) through 18 months. Mean post-washout intraocular pressure at month 13 was 33% lower than preoperative unmedicated intraocular pressure. No adverse events occurred through 18 months.

Conclusions and relevance: In open-angle glaucoma eyes on two preoperative medications, treatment with two second-generation trabecular stents and one postoperative prostaglandin resulted in mean intraocular pressure ≤ 13 mmHg with reduction of one medication, with favourable safety. These findings show the utility of second-generation trabecular bypass with postoperative prostaglandin in patients with open-angle glaucoma.


MeSH Terms

Administration, TopicalAntihypertensive AgentsCoated Materials, BiocompatibleFemaleFollow-Up StudiesGlaucoma, Open-AngleGonioscopyHumansIntraocular PressureMaleMiddle AgedProspective StudiesProsthesis DesignStentsTime FactorsTrabecular MeshworkTravoprostTreatment OutcomeVisual Acuity

Key Concepts6

In a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre, treatment with two second-generation trabecular micro-bypass stents and one postoperative prostaglandin resulted in a mean intraocular pressure of ≤ 13.0 mmHg (a ≥ 34% reduction) with reduction of one medication through 18 months in open-angle glaucoma eyes (N=53) on two preoperative medications.

TreatmentCohortProspective Cohortn=53 eyesCh12Ch31Ch45

In a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre, 91% of open-angle glaucoma eyes (N=53) on two preoperative medications achieved an intraocular pressure reduction ≥ 20% with reduction of one medication at 12 months following implantation of two second-generation trabecular micro-bypass stents and postoperative topical travoprost.

TreatmentCohortProspective Cohortn=53 eyesCh12Ch31Ch45

In a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre, all open-angle glaucoma eyes (N=53) on two preoperative medications had intraocular pressure ≤ 18 mmHg with reduction of one medication at 12 months following implantation of two second-generation trabecular micro-bypass stents and postoperative topical travoprost.

TreatmentCohortProspective Cohortn=53 eyesCh12Ch31Ch45

In a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre, 87% of open-angle glaucoma eyes (N=53) on two preoperative medications had intraocular pressure ≤ 15 mmHg at 12 months following implantation of two second-generation trabecular micro-bypass stents and postoperative topical travoprost.

TreatmentCohortProspective Cohortn=53 eyesCh12Ch31Ch45

In a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre, mean post-washout intraocular pressure at month 13 was 33% lower than preoperative unmedicated intraocular pressure in open-angle glaucoma eyes (N=53) treated with two second-generation trabecular micro-bypass stents and postoperative topical travoprost.

TreatmentCohortProspective Cohortn=53 eyesCh12Ch31Ch45

In a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre, no adverse events occurred through 18 months following implantation of two second-generation trabecular micro-bypass stents and postoperative topical travoprost in open-angle glaucoma eyes (N=53).

TreatmentCohortProspective Cohortn=53 eyesCh12Ch31Ch45

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