Study for reduction of Eye Pressure

Completed

Conditions: Glaucoma,

Registration Number: CTRI/2019/06/019564

Lead Sponsor: iSTAR Medical SA

Brief Summary: The aim of this study is to assess the efficacy and safety of the MINIject system in patients diagnosed with primary open angle glaucoma uncontrolled by topical hypotensive medications. MINIject is intended to be used to reduce the intraocular pressure (IOP) by channeling aqueous humour out of the anterior chamber to a sub-scleral location, thus enhancing the physiological uveoscleral outflow.

MINIject is indicated in adult, male and female patients diagnosed with primary or secondary open angle glaucoma, and where the progression of glaucoma is not adequately controlled by topical hypotensive medication(s).

MINIject is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant and a Delivery Tool. The Delivery Tool is configured for inserting the implant into the sub-scleral location through an ab-interno minimally-invasive approach.

The delivery tool is single-use. The intervention is to be performed as stand-alone surgery.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 25

Inclusion Criteria

Males or females, 18 years of age or older.
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 by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.
Patients must be willing and able to return for scheduled study-related examinations.
Patients must provide written informed consent.

Exclusion Criteria

Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
Neovascular glaucoma in the study eye.
Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
Prior glaucoma surgery in the study eye.
Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed â‰¥ 90 days before baseline visit in the study eye.
Visual field defect in the 10-degree central field in the study eye.
Any eye surgery that was performed â‰¥ 90 days before baseline visit in the study eye.
Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery in the study eye.
Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
Pre-existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.
Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
Evidence of crystalline lens subluxation or luxation in the study eye.
Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye.
Presence of silicone oil in the study eye.
Patients treated with systemic acetazolamide within 3 days before screening/baseline visit.
Patient with poor vision score: +1.0 in non-study eye, unless there is an expected benefit for the study eye in the opinion of the investigator.
Participation in any study involving an investigational drug or device within the past 3 months and planned participation to any other study during the present study.
Only for women of childbearing potential: positive blood pregnancy test at baseline visit.
Individuals under tutorship or trusteeship.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at baseline visit.	The reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at baseline visit.

Secondary Outcome Measures

Name	Time	Method
To test the absolute and relative (in%) reduction in medicated diurnal IOP between baseline visit and medicated diurnal IOP at 12- and 24 months after surgery.	To assess the â€˜complete successâ€™ rate at 12 and at 24 months after surgery.

Trial Locations

Locations (1): Maxivision Super Speciality Eye Hospital
🇮🇳
Hyderabad, TELANGANA, India
Maxivision Super Speciality Eye Hospital
🇮🇳Hyderabad, TELANGANA, India
Dr Kasu Prasad Reddy
Principal investigator
9848046919
kasuprasadreddy@gmail.com