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NCT03374553 Clinical Trial

MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Open Angle Glaucoma Clinical Trial

Official title:
A Prospective, Open, Multicentre Clinical Trial Analysing the Effectiveness and Safety of MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03374553
Other study ID # ISM05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2017
Est. completion date February 8, 2021

Study information
Verified date April 2022
Source iSTAR Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will evaluate the efficacy and safety of MINIject 636 and IOP lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery. The primary efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date February 8, 2021
Est. primary completion date January 17, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. - Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System. - Glaucoma not adequately controlled Exclusion Criteria: - Diagnosis of glaucoma other than open angle glaucoma - Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System. - Neovascular glaucoma in the study eye - Prior glaucoma surgery in the study eye - Clinically significant corneal disease - Patients with poor vision

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MINI DO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool. The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach. For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant. Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT). DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).
• MINI SO636
MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool. The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach. For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant. Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT). DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).

Locations
Country Name City State
Colombia Clínica Oftalmológica del Caribe Barranquilla
India Maxivision Eye Hospital Hyderabad Telangana
Panama Panama Eye Center Panama city

Sponsors (1)
Lead Sponsor Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Colombia,  India,  Panama, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in medicated diurnal IOP DODT/SODT arm will be evaluated separately 6 months after surgery
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