Actively Recruiting
Minimally Invasive Micro Sclerostomy (MIMS4) Inferonasal Procedure: Long-Term Follow-Up Extension Study
Led by Sanoculis Ltd · Updated on 2024-09-26
53
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a long-term follow-up extension study to collect data from people who have previously had the Minimally Invasive Micro Sclerostomy (MIMS4) inferonasal surgery. This observational study aims to evaluate changes in intraocular pressure and the use of eye pressure-lowering medications over 24 and 30 months after the surgery. The study also monitors the success rate of the surgery and safety outcomes related to postoperative complications and interventions. Participants in this study are those who underwent the MIMS4 inferonasal procedure using the proprietary MIMS4 device, which creates a small opening in the inferonasal part of the eye. This study involves one group of participants who have already had this surgery, and it focuses on collecting follow-up data without introducing any new treatments or interventions. During the study, participants will be observed over periods of 24 and 30 months post-surgery. Researchers will measure intraocular pressure changes, track the number of topical medications used to lower eye pressure, and assess the long-term safety and success of the surgery. No additional procedures are performed, and the study mainly involves data collection from previous surgical patients. The total participation duration aligns with the 30 months of follow-up after their prior surgery.
CONDITIONS
Brief Title
Inferonasal MIMS® Procedure: Long-Term Follow-Up Extension Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject who underwent MIMS4 inferonasal procedure
- Surgery performed not earlier than 24 months before enrollment
- Age between 40 and 85 years
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 years post-surgery
Participants who have previously undergone the Inferonasal MIMS® surgery are observed for changes in intraocular pressure and medication use, as well as safety outcomes.
Follow-up visits over 24 to 30 months post-surgery
Trial Site Locations
Total: 1 location
1
S. Malayan Eye Center
Yerevan, Armenia
Actively Recruiting
Research Team
K
Khan Lau, OD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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