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

Not Applicable

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Device: MINI DO636; Device: MINI SO636

• Registration Number: NCT03374553
• Lead Sponsor: iSTAR Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-25
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-15
• Primary Completion: 2019-01-17
• Study Completion: 2021-02-08
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MINIject DO Integrated System CS636 (MINI DO636)	MINI DO636	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. In this arm the implant is placed using Dual Operator Delivery Tool (DODT).
MINIject SO Integrated System CS636 (MINI SO636)	MINI SO636	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. In this arm the implant is placed using Single Operator Delivery Tool (SODT).

Primary Outcome Measures

Name	Time	Method
Reduction in medicated diurnal IOP	6 months after surgery	DODT/SODT arm will be evaluated separately

Trial Locations

Locations (3)

Clínica Oftalmológica del Caribe; 🇨🇴 Barranquilla, Colombia

Maxivision Eye Hospital; 🇮🇳 Hyderabad, Telangana, India

Panama Eye Center; 🇵🇦 Panama city, Panama