MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03374553|
Recruitment Status : Active, not recruiting
First Posted : December 15, 2017
Last Update Posted : August 21, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma||Device: MINIject 636 implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 25, 2017|
|Actual Primary Completion Date :||January 17, 2019|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: MINIject 636 implant
MINIject 636 implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive glaucoma surgical intervention.
The intervention is to be performed as stand-alone surgery.
Device: MINIject 636 implant
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.
- Reduction in medicated diurnal IOP [ Time Frame: 6 months after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374553
|Clínica Oftalmológica del Caribe|
|Maxivision Eye Hospital|
|Hyderabad, Telangana, India, 500034|
|Panama Eye Center|
|Panama city, Panama|
|Study Director:||Zubair Hussain, PhD||iSTAR Medical|