This Follow-up Extension Study is Aimed to Monitor the Long-term IOP-lowering Performance/Efficacy and Safety of the MINT® Procedure in Open Angle Glaucoma Eyes.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension Open-angle Glaucoma

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmological Center After S.V Malayan

Yerevan, Armenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female ≥ 18 years to ≤ 85 years old
Subject who underwent MINT, in continuation of the previous clinical investigation with the MINT® device (see: STUDY ID: MMS EEU-4), and surgery was performed not earlier than 30 months from enrollment
Subject is able and willing to attend all scheduled follow-up exams
Subject understands and signs the informed consent

Exclusion criteria

Subject who was withdrawn from the previous studies (MMS EEU-4 and MMS EEU-7)
Any ocular surgery since the MINT® surgery in the study eye
Severe trauma in the study eye since the MINT® surgery in the study eye (except for uncomplicated cataract surgery or laser therapy)
Current participation in another investigational drug or device clinical trial or participation is such trial within the last 30 days before enrollment into the study
Pregnant or lactating women

Treatment and study plan

MINT Minimally Invasive Nasal Trabeculostomy

Device

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.

Primary outcomes

Success will be evaluated as following:

Time frame: • Success rates 36 months post-MINT® surgery
- 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.

Sponsors and collaborators

Lead sponsor

Sanoculis Ltd

Industry

Registry information

Official study title

Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Jul 23, 2025
Registry last updated: Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting