MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract

Cataract Clinical Trial

— STAR-VI  

Official title:

A Prospective, Open, Multicenter Clinical Trial Evaluating the Efficacy and Safety of MINIject Combined With Cataract Surgery in Patients With POAG Uncontrolled by Topical Hypotensive Medications and Operable Age-related Cataract Diagnosis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05432245
• Other study ID #: STAR VI
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2023
• Source: iSTAR Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess safety and performance of MINIject implant in patients with open-angle glaucoma uncontrolled by topical hypotensive medications in conjunction with cataract surgery.

Description:

The study aims to evaluate the safety and efficacy of the MINIject in the reduction of intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) in conjunction with cataract surgery. The cataract surgery will be performed first and if successful, only then will the MINIject be placed. Patients will be followed for 2 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of primary open angle glaucoma (POAG) in the study eye
• Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
• Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the patient has an allergy / intolerance to a medication
• Patient must provide written informed consent to participate

Exclusion Criteria:

• Known or suspected allergy or hypersensitivity to medical silicone
• Allergy to fluorescein
• Presence of silicone oil in the study eye
• Individuals under tutorship or trusteeship
• Patient has a condition such that his / her ability to provide personal informed consent is compromised

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Device:
• Phacoemulsification combined with minimally invasive glaucoma surgery (MIGS)
The cataract surgery will be performed first and if successful, only then will the MINIject be placed into supraciliary space.

Locations

Country	Name	City	State
Panama	Panama Eye Center	Panama City
Spain	Hospital Clínico San Carlos	Madrid
United Kingdom	East Suffolk and North Essex NHS Foundation Trust - Colchester General Hospital	Colchester	Essex
United Kingdom	Princess Alexandra Eye Pavilion	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Panama,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of study eyes achieving = 20% reduction in diurnal IOP	Proportion of study eyes achieving = 20% reduction in diurnal IOP from baseline to 6 months follow-up, with or without IOP lowering medications	6 months