Supraciliary Microstent in Refractory Open-Angle Glaucoma: Two-Year Outcomes from the DUETTE Trial

García‐Feijoó, Julián; Höh, H.; Uzunov, R.; Dickerson, Jaime E.

doi:10.1089/jop.2018.0036

Cited by 17 publications

(10 citation statements)

References 20 publications

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“… 28 Recent evidence has indicated that uveoscleral outflow may account for ∼50% of aqueous drainage in normal human eyes and is thought to be higher in glaucomatous patients, in whom redirection toward the uveoscleral pathway occurs. 29 – 31 There is also evidence that supraciliary microstenting has significant IOP-lowering capabilities 11 , 13 , 32 , 33 and does not face the IOP-lowering limitation of episcleral venous pressure that is encountered when targeting the conventional outflow pathways such as during trabecular bypass. However, it is also known that supraciliary devices may cause a scarring reaction that may limit success rates.…”

Section: Discussionmentioning

confidence: 99%

“…However, it is also known that supraciliary devices may cause a scarring reaction that may limit success rates. 8 , 29 , 32 The use of suitable materials that minimize and prevent tissue scarring and foreign body reactions has been suggested by Gigon and Shaarawy. 29 In preclinical studies in rabbits, the MINIject implant produced limited fibrous encapsulation around the device, and caused minimal inflammatory reaction in an animal model that is known for aggressive ocular fibrosis.…”

Section: Discussionmentioning

confidence: 99%

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A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)

Feijoó

Denis

Hirneiß

et al. 2020

Journal of Glaucoma

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Precis: In this European study (STAR-II), MINIject, a novel, ab-interno, supraciliary minimally invasive glaucoma surgery device, effectively lowered intraocular pressure (IOP) and the need for IOP-lowering medications in patients with primary open-angle glaucoma. Purpose: This study evaluates the safety and performance of a minimally invasive supraciliary glaucoma drainage device (MINIject DO627) for surgical treatment of primary open-angle glaucoma in patients refractory to topical hypotensive medications. Methods: In a prospective, interventional, single-arm, multicenter, European study (STAR-II), MINIject was successfully implanted in a stand-alone procedure in 29 of 31 patients in 8 sites in 3 countries. The primary endpoint was the success rate 6 months after surgery >60% (defined as diurnal IOP ≤21 and >5 mm Hg with ≥20% IOP reduction from baseline, with/without glaucoma hypotensive medication). ClinicalTrials.gov: NCT03624361. Results: At the 6-month follow-up, the primary endpoint was fulfilled, with 75.9% of patients reaching prospectively defined success. The mean IOP was reduced by 40.2% (9.9 mm Hg) to 14.7±6.0 mm Hg at 6 months from 24.6±3.8 mm Hg at baseline. The use of IOP-lowering medication ingredients was reduced by 63.4% from 2.9±1.2 at baseline to 1.0±1.3. Furthermore, 79.3% of the patients had mean IOP ≤18 mm Hg, 82.8% achieved a ≥20% IOP reduction, and 55.2% were medication free at 6 months. Six device-related serious adverse events were reported in the study eye: IOP increase (3/31 patients, 9.7%), and single reports of eye pain, corneal erosion, and chorioretinal folds (1/31, 3.2%), all of which resolved. There was minimal change to corneal endothelial cell density. Conclusion: Ab-interno supraciliary surgical implantation using MINIject DO627 in a stand-alone procedure significantly lowers IOP by 40% at the 6-month follow-up, while reducing the need for IOP-lowering medication.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)

Feijoó

Denis

Hirneiß

et al. 2020

Journal of Glaucoma

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“…The Trabectome procedure lowered IOP by 33% at 6 months in its pivotal study [15]. In a non-randomized case series, the CyPass supraciliary microstent device lowered mean IOP by 29.4% at 6 months, 34.7% at 12 months, and by 31.4% at 24 months, with medication use reduced by 28.6% at 2 years; adverse events included cataract progression (12%), IOP spikes (11%), and hyphema (6%) [16, 17]. The CyPass device has recently been voluntarily recalled from the global marketplace because of safety concerns related to 5-year corneal endothelial cell loss [18].…”

Section: Discussionmentioning

confidence: 99%

Six-Month Outcomes of Goniotomy Performed with the Kahook Dual Blade as a Stand-Alone Glaucoma Procedure

Berdahl

Gallardo²,

ElMallah

et al. 2018

Adv Ther

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IntroductionTo characterize the reduction in intraocular pressure (IOP) and IOP-lowering medication use following goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade as a stand-alone procedure in adult eyes with glaucoma uncontrolled on a regimen of 1–3 topical IOP-lowering medications.MethodsIn this retrospective analysis, data from consecutive patients undergoing goniotomy with the Kahook Dual Blade by 11 surgeons were analyzed. Preoperative, intraoperative, and postoperative follow-up data through 6 months of follow-up were collected. The primary efficacy endpoint was IOP reduction from preoperative baseline; reduction in IOP-lowering medication use was a secondary endpoint.ResultsData were collected from 53 eyes of 42 subjects. Mean (± SE) preoperative IOP was 23.5 ± 1.1 mmHg, and from day 1 through 6 months of postoperative follow-up mean IOP reductions of 7.0–10.3 mmHg (29.8–43.8%; p < 0.001 at each time point) were observed. Mean preoperative medication use was 2.5 ± 0.2 medications per eye and was reduced by month 6 to 1.5 ± 0.2 (a 40.0% reduction; p < 0.05). Eyes with higher baseline IOP experienced mean IOP reductions of 13.7 mmHg (− 46.4%) at month 6, while eyes with lower baseline IOP experienced mean IOP reductions of 3.8 mmHg (− 21.0%) at month 6. Mean medications were reduced by 1.3 medications in high-IOP eyes and by 0.9 in low-IOP eyes at month 6. No significant sight-threatening adverse events were observed.ConclusionsGoniotomy via trabecular meshwork excision performed using the Kahook Dual Blade effectively and safely lowered IOP when performed as a stand-alone procedure in eyes with glaucoma. The significant drop in IOP met or exceeded the recommended targets for these glaucoma patients.FundingNew World Medical, Inc.

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“…Stand-alone CyPass (Alcon) implantation (n=65) was shown at 2 years in the DUETTE study to decrease IOP from a mean of 24.5±2.8 mmHg to 16.8±3.9 mmHg (−31% reduction) (n=32) with 56.3% having a 20% reduction of IOP from baseline and a mean medication reduction from 2.2±1.1 at baseline to 1.5±1.2 at 2 years. 16 At 2 years, 12 eyes (18.5%) required additional glaucoma surgery. 17 Success was defined as IOP between 6 and 21 mmHg on no medications (complete success: 29.2%) or on same or fewer medications (qualified success: 62.5%).…”

Section: Discussionmentioning

confidence: 99%

Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial

et al. 2020

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Background/AimsThe current study evaluates the efficacy and safety of the stand-alone implantation of the MINIject (iSTAR Medical, Wavre, Belgium) supraciliary, microinvasive glaucoma drainage device in patients with medically uncontrolled open-angle glaucoma.MethodsThis prospective, multicentre, first-in-human, single-arm interventional study evaluated stand-alone, ab interno implantation in 25 patients of a 5 mm long uveoscleral device made of STAR biocompatible material, which is a soft, microporous, flexible silicone. The primary outcome was the reduction of intraocular pressure (IOP) at 6 months compared with baseline, and follow-up continued until 2 years for 21 patients. Secondary outcomes included success defined as diurnal IOP of ≤21 mmHg and >5 mmHg with an IOP reduction of 20% without (complete) or with/without (qualified) glaucoma medication.ResultsMean baseline IOP was 23.2±2.9 mmHg on 2.0±1.1 glaucoma medication ingredients and decreased to 13.8±3.5 mmHg (−40.7% reduction) on 1.0±1.3 medications 2 years after implantation. Complete success was achieved in 47.6% of patients (10/21) and qualified success in 100% of patients (21/21) at the 2-year follow-up. All patients achieved a 20% IOP reduction with 48% of patients medication-free. No serious ocular adverse events or additional glaucoma surgery were reported. Mean central endothelial cell density (ECD) mildly decreased from 2411 cells/mm2 (n=26) to 2341 cells/mm2 (n=21) at 24 months, which represents a 5% decrease for matched eyes. No patient had a ≥30% decrease in central ECD.ConclusionThis first-in-human study on the stand-alone implantation of the MINIject supraciliary drainage system shows promising IOP-lowering results and medication reduction over 24 months with few adverse events.Trial registration numberNCT03193736.

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Supraciliary Microstent in Refractory Open-Angle Glaucoma: Two-Year Outcomes from the DUETTE Trial

Abstract: Placement of a supraciliary microstent provides up to 24 months of effective IOP lowering for medication-refractory POAG patients while, on average, decreasing the requirement for ocular hypotensive medications.

Cited by 17 publications

References 20 publications

A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)

A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II)

Six-Month Outcomes of Goniotomy Performed with the Kahook Dual Blade as a Stand-Alone Glaucoma Procedure

Two-year outcomes of the MINIject drainage system for uncontrolled glaucoma from the STAR-I first-in-human trial

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