Study for reduction of Eye Pressure

Not Applicable

Completed

• Conditions: Health Condition 1: null- Patients with Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

• Registration Number: CTRI/2018/02/012240
• Lead Sponsor: iSTAR Medical SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-10
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Males or females, 18 years of age or older.

2. Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.

3. Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.

4. Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21 mmHg � IOP � 35 mmHg in the study eye at screening and baseline visits.

5. Patient must be willing and able to return for scheduled study-related examinations.

6. Patient must provide written informed consent.

Exclusion Criteria

1. Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.

2. 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.

3. Neovascular glaucoma in the study eye.

4. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant.

5. Prior eye surgery in the study eye within 90 days before screening visit.

6. Prior glaucoma surgery in the study eye, except patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye may be eligible if treatment performed � 90 days before screening visit.

7. Visual field defect in the 10 degree central field in the study eye.

8. Anticipated need for ocular surgery or retinal laser procedure in the study eye in the 12 months following surgery.

9. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.

10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.

11. 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.

12. Evidence of crystalline lens subluxation or luxation in the study eye.

13. Evidence of vitreous loss in the anterior chamber in the study eye.

14. 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.

15. Presence of silicone oil in the study eye.

16. Patients treated with systemic acetazolamide within 3 days before screening visit.

17. Patients 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.

18. Participation in any study involving an investigational drug or device within the past 3 Months.

19. Only for women of childbearing potential: positive urine pregnancy test at screening.

20. Individuals under tutorship or trusteeship.

Study & Design

• Study Type: Interventional
• Study Design: Not specified