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.
- Conditions
- GlaucomaOcular HypertensionOpen-Angle Glaucoma
- Registration Number
- NCT07081347
- Lead Sponsor
- Sanoculis Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 47
- 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
- Subject who was withdrawn from the previous studies (MMS EEU-4 and MMS EEU-7)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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Success will be evaluated as following: • 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ophthalmological Center After S.V Malayan
🇦🇲Yerevan, Armenia
Ophthalmological Center After S.V Malayan🇦🇲Yerevan, Armenia