Study for reduction of Eye Pressure

Completed

• Conditions: PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS

• Registration Number: CTRI/2018/03/012458
• 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 open angle glaucoma uncontrolled by topical hypotensive medications. MINIject is intended to be used to reduce the intraocular pressure (IOP) by channelling 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

Study Timeline

• Study Start: 2017-07-22
• Last Update Posted: 2018-06-03
• Study Completion: 2019-11-16

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 ≤ 35mmHg in the study eye at screening and baseline visits.
• • Patients must be willing and able to return for scheduled study-related examinations.
• • Patients must provide written informed consent.

Exclusion Criteria

• • Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.
• • 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.
• • 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.
• • 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 ≥ 90 days before screening visit.
• • Visual field defect in the 10-degree central field in the study eye.
• • Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery.
• • 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.
• • Patient with poor vision (LogMar score: +1.0) in non-study eye, unless there is an expected benefit for the study eye in the opinion of the investigator.
• • Only for women of childbearing potential: positive urine pregnancy test at screening.
• • Individuals under tutorship or trusteeship.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at screening visit	6 months

Secondary Outcome Measures

Name	Time	Method
Absolute and relative reduction (in %) of medicated diurnal IOP compared to medicated	diurnal IOP at screening visit.

Trial Locations

Locations (1)

Maxivision Super Speciality Eye Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Maxivision Super Speciality Eye Hospital

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Kasu Prasad Reddy

Principal investigator

9848046919

kasuprasadreddy@gmail.com