| CTRI Number |
CTRI/2019/06/019564 [Registered on: 06/06/2019] Trial Registered Prospectively |
| Last Modified On: |
22/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study for reduction of Eye Pressure |
|
Scientific Title of Study
|
A PROSPECTIVE, OPEN, MULTICENTRE CLINICAL TRIAL ANALYSING THE EFFECTIVENESS AND SAFETY OF MINIJECT (MINI SO627) IN PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS USING A SINGLE OPERATOR DELIVERY TOOL |
| Trial Acronym |
ISM08 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2019/ISM08 Version 1.0; 08-Jan-2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kasu Prasad Reddy |
| Designation |
Chief Consultant,Cataract and Refractive Surgery |
| Affiliation |
Maxivision Super Speciality Eye Hospital |
| Address |
6-3-903/A/1/1, Behind Yashoda Hospital, Somajiguda
Hyderabad
ANDHRA PRADESH
India
Hyderabad
TELANGANA
500082
India |
| Phone |
|
| Fax |
|
| Email |
kasuprasadreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kasu Prasad Reddy |
| Designation |
Chief Consultant,Cataract and Refractive Surgery |
| Affiliation |
Maxivision Super Speciality Eye Hospital |
| Address |
6-3-903/A/1/1, Behind Yashoda Hospital, Somajiguda
Hyderabad
ANDHRA PRADESH
India
Hyderabad
TELANGANA
500082
India |
| Phone |
|
| Fax |
|
| Email |
kasuprasadreddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naresh Kumar Pagidimarry |
| Designation |
CEO & M D |
| Affiliation |
8C Healthcare Private Limited |
| Address |
1207, 13th Street, Vijaya Bank Road, Gandhinagar
Hyderabad
ANDHRA PRADESH
India
Hyderabad
TELANGANA
500080
India |
| Phone |
|
| Fax |
|
| Email |
naresh.pagidimarry@8chealthcare.com |
|
|
Source of Monetary or Material Support
|
| iSTAR Medical SA Avenue Sabin, 6 1300 Wavre Belgium |
|
|
Primary Sponsor
|
| Name |
iSTAR Medical SA |
| Address |
Avenue Sabin, 6 1300 Wavre Belgium |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Panama
Colombia
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kasu Prasad Reddy |
Maxivision Super Speciality Eye Hospital |
Glaucoma Department,
6-3-903/A/1/1, Behind
Yashoda Hospital
Somajiguda
Hyderabad
ANDHRA PRADESH
Hyderabad
TELANGANA |
9848046919
kasuprasadreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| STAR Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H40-H42||Glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MINI SO627 |
Glaucoma Drainage Device |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.
5. Patients must be willing and able to return for scheduled study-related examinations.
6. Patients must provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. 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.
2. Neovascular glaucoma in the study eye.
3. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
4. 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 baseline visit in the study eye.
5. Visual field defect in the 10-degree central field in the study eye.
6. Any eye surgery that was performed ≥ 90 days before baseline visit in the study eye.
7. Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery in the study eye.
8. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
9. 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.
10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
11. Evidence of crystalline lens subluxation or luxation in the study eye.
12. Evidence of vitreous loss in the anterior chamber in the study eye.
13. 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.
14. Presence of silicone oil in the study eye.
15. Patients treated with systemic acetazolamide within 3 days before screening/baseline visit.
16. 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.
17. 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.
18. Only for women of childbearing potential: positive blood pregnancy test at baseline visit.
19. Individuals under tutorship or trusteeship. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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 ‘complete success’ rate at 12 and at 24 months after surgery.
To assess the ‘qualified success’ rate at 12 and 24 months after surgery. |
Day 1, Week 1, Week 2, Month 1, Month 3,
Month 6, Month 12, Month 18, Month 24 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="4" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/06/2019 |
| Date of Study Completion (India) |
10/01/2022 |
| Date of First Enrollment (Global) |
10/06/2019 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |