An interventional study of MINT Minimally Invasive Nasal Trabeculostomy in Glaucoma, Ocular Hypertension and Open-Angle Glaucoma, sponsored by Sanoculis Ltd. Active, not recruiting at 1 site in Armenia. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.
Sponsored by Sanoculis Ltd · Not applicable, Interventional, and Treatment
This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study.
It is assumed that approximately 20 patients/eyes, achieved qualified success of ≥20% IOP reduction from baseline without reoperation for glaucoma and with same or less medications in the prior MMS EEU-7 study, will be available for assessment in this study. The data from these patients will be included in the IOP performance and medication use analysis.
In addition to these subjects, data from subjects defined as failure in the prior investigations with MINT® (see: STUDY ID: MMS EEU-4; STUDY ID: MMS EEU-7) will be included in the overall success analysis (i.e., Kaplan Mayer survival analysis).
Based on recommendations of the EGS expert discussion group (European Glaucoma Society (EGS), 2023), the IOP levels of 2-3 mmHg and 20%-30% medication free patients have been proposed as the minimal clinically important difference (MCID) for surgical interventions for glaucoma.
In this study, by 3 years post MINT® surgery, a sample size of 20 patients is expected to be adequate to demonstrate a reduction of at least -6 mmHg with 95% confidence interval (CI) lower limit of at least -4.6 mmHg which is higher than the MCID required; and at least 45% of free-medication patients with 95%CI lower limit of 21.8% which is in line with the minimum MCID recommendations.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 47 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Sanoculis Ltd is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants will undergo a single MINT® (Minimally Invasive Nasal Trabeculostomy) procedure as a standalone or combined intervention for the treatment of glaucoma. All participants will be followed for 36 months to evaluate intraocular pressure (IOP) outcomes, reduction in IOP-lowering medications, and safety parameters.
Device: MINT Minimally Invasive Nasal Trabeculostomy
The MINT® system is a powered surgical device for ab-interno nasal trabeculostomy. It creates \~100-micron trabeculostomy openings from the anterior chamber into Schlemm's canal by removing trabecular meshwork (TM) segments. The system includes a sterile stainless-steel Surgical Device with a micro trephine, driven by a motorized Activation Device that controls rotation and movement. The procedure facilitates aqueous outflow to lower IOP, with minimal collateral tissue damage.
Success will be evaluated as following:
* Proportion of patients achieving ≥20% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony\*, while staying on same or fewer topical IOP-lowering medications than at baseline. * Proportion of patients achieving ≥25% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony\*, while staying on same or fewer topical IOP-lowering medications than at baseline * Proportion of patients achieving ≥20% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony\*, while taking no topical IOP-lowering medications. * Proportion of patients achieving ≥25% IOP reduction from medicated baseline with no secondary surgical intervention (SSI) for glaucoma and no clinical hypotony\*, while taking no topical IOP-lowering medications.
Time frame: • Success rates 36 months post-MINT® surgery
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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