NCT07081347Completed
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.
Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 47 (actual)
- First submitted
- 15 Jul 2025
- Start date
- 16 Jun 2025
- Primary completion date
- 2 Aug 2025
- Lead sponsor
- Sanoculis Ltd
- Diseases
- Glaucoma, High blood pressure
- NCT number
- NCT07081347
What you commit to
- Study type: Interventional
- Participants enrolled: 47
- From 16 Jun 2025 to the primary completion date, 2 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ophthalmological Center After S.V Malayan Coordinator of this site? Confirm its status | Yerevan | Armenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.