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Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study

NCT04484155 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-11-30

No results posted yet for this study

Summary

Eligible Glaucoma patients will undergo pre-surgery examination including:

medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered .

The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall \[scleral tissue\] . MIMS procedure may be combined with cataract surgery.

Patients will be followed up to 24 weeks post operation.

Conditions

Interventions

DEVICE

Minimally Invasive Micro Sclerostomy (MIMS)

The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.

Sponsors & Collaborators

  • Sanoculis Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2020-03-02
Completion
2020-03-05

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04484155 on ClinicalTrials.gov