MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
|ClinicalTrials.gov Identifier: NCT03996200|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma, Open-Angle Glaucoma Eye||Device: MINIject CS627 implant||Not Applicable|
The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.
The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||MINIject SO627|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open, Multicentre Clinical Trial Analysing the Efficacy and Safety of Miniject (MINI SO627) in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications Using a Single Operator Delivery Tool|
|Actual Study Start Date :||July 23, 2019|
|Actual Primary Completion Date :||February 14, 2020|
|Estimated Study Completion Date :||October 2021|
Experimental: MINIject CS627 implant
MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.
Device: MINIject CS627 implant
MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool.
The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.
- medicated diurnal IOP [ Time Frame: 6 months post surgery ]Change in medicated diurnal IOP
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996200
|Clinica Oftalmologica del Caribe|
|Maxivision Eye Hospital|
|Hyderabad, Telangana, India, 500034|
|Panama Eye Center|
|Panama City, Panama|
|Study Director:||Zubair Hussain||iSTAR|