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Recruiting NCT06577857

Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study

— Observational Open Angle Glaucoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inferonasal Minimally Invasive Micro Sclerostomy.
Who it may be relevant to
Registry conditions: Open Angle Glaucoma. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Armenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Minimally Invasive Micro Sclerostomy (MIMS®) Inferonasal Procedure: Long-Term Follow-Up Extension Study

Overview

A long-term (24 and 30 months) follow-up extension, prospective, non-interventional, open label study for data collection from subjects who underwent prior MIMS® inferonasal surgery, in continuation of the previous clinical investigation with the MIMS® Device (MMS-EEU-5).

Interventions

  • Device Inferonasal Minimally Invasive Micro Sclerostomy
    The Inferonasal MIMS® procedure uses the proprietary MIMS® device, which creates a sclerostomy in the inferonasal quadrant of the eye.

Primary outcome measures

  • Intraocular Pressure Change (Baseline to 24 months) [Time frame: Baseline to 24 months post-MIMS® surgery]
  • Intraocular Pressure Change (Baseline to 30 months) [Time frame: Baseline to 30 months post-MIMS® surgery]
  • Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 24 Months) [Time frame: Medicated baseline to 24 months post-MIMS® surgery]
  • Change in Number of Topical Intraocular Pressure Lowering Medications (Baseline to 30 Months) [Time frame: Medicated baseline to 30 months post-MIMS® surgery]
  • Surgery Success Rate (24 months) [Time frame: 24 months post-MIMS® surgery]
  • Surgery Success Rate (30 months) [Time frame: 30 months post-MIMS® surgery]
Secondary outcome measures (2)
  • Postoperative Complication Safety Outcomes [Time frame: Baseline to 30 months post-MIMS® surgery]
  • Interventional Safety Outcomes [Time frame: Baseline to 30 months post-MIMS® surgery]

Eligibility criteria

Inclusion criteria

1\. Subject who underwent MIMS® inferonasal procedure, and surgery was performed not earlier than 24 months from enrollment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Armenia · 1 center
  • S. Malayan Eye Center — Yerevan

Identifiers

NCT: NCT06577857 · MMS-EEU-8

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗