| CTRI Number |
CTRI/2017/07/008975 [Registered on: 05/07/2017] Trial Registered Prospectively |
| Last Modified On: |
28/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study, to Investigate the Safety and Device Performance of Pars Plana Vitrectomy Surgery Using a Hypersonic Vitrector Handpiece. |
|
Scientific Title of Study
|
A Study to Investigate the Safety and Device Performance of Pars Plana
Vitrectomy Surgery Using a Hypersonic Vitrector Handpiece |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 879; Version 2.0; 13 Jun 2017 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amar Agarwal |
| Designation |
Chairman |
| Affiliation |
Dr. Agarwals group of eye hospitals |
| Address |
No 19 Cathedral Road, Gopalapuram, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600086
India |
| Phone |
04428112811 |
| Fax |
|
| Email |
aehl19c@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rakesh Prasad |
| Designation |
Manager, Regulatory Affairs |
| Affiliation |
Bousch & Lomb India |
| Address |
Regulatory Affairs, Room No 9, 4th Floor, Tower B, Unitech Business Park, Gurgaon, Haryana, India – 122 002
Gurgaon
HARYANA
122 002
India |
| Phone |
08800229917 |
| Fax |
|
| Email |
rakesh.prasad@bausch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Director Operations |
| Affiliation |
CBCC Global Research LLP-India |
| Address |
Clinical Operations Department, Room NO 5, 2nd Floor, Skoda House, Opp. LJ Campus, SG Highway
Sarkhej, Ahmedabad – 382210 , India
Ahmadabad
GUJARAT
382210
India |
| Phone |
09637555304 |
| Fax |
09726434204 |
| Email |
sandeep.singh@vibgyorcare.com |
|
|
Source of Monetary or Material Support
|
| Bausch & Lomb Incorporated, a division of Valeant Pharmaceuticals North America, LLC
1400 North Goodman StreetRochester, NY 14609
|
|
|
Primary Sponsor
|
| Name |
Bausch Lomb Incorporated |
| Address |
Valeant Pharmaceuticals NA LLC/Bausch & Lomb Incorporated, (a division of Valeant Pharmaceuticals North America, LLC)
400 Somerset Corporate Boulevard, Bridgewater, NJ 08807
|
| Type of Sponsor |
Other [Pharmaceutical Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amar Agarwal |
Agarwal’s Eye Hospital |
Room NO 1, Ground Floor, No 19 Cathedral Road, Gopalapuram, Chennai, Tamil Nadu 600086
Chennai
TAMIL NADU |
04428112811
aehl19c@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Agarwal’s Eye Hospital Institutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
For vitrectomy based on a diagnosis of one of the following conditions: vitreoretinal traction, asteroid hyalosis, macular pucker/epiretinal membrane, macular hole, or vitreous hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypersonic vitrector is an ultrasonic handpiece attached to the Stellaris Elite Vision Enhancement System |
The hypersonic vitrector is an ultrasonic handpiece that is attached to the Stellaris Elite Vision Enhancement System. It is intended for use by a surgeon to effectively remove vitreous humor and other material from the posterior segment of the eye, using ultrasound energy and aspiration. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
This study will include subjects who meet all of the following:
1. Subjects must be 40 years of age or older on the date the Informed Consent Form (ICF) is signed.
2. Subjects must provide written informed consent on the IRB/EC-approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy protection regulations.
3. Subjects must be willing and able to comply with all treatment and follow-up study procedures.
4. Subjects undergoing optical coherence tomography (OCT) and fundus imaging must have adequate pupillary dilatation and clear media to perform imaging studies including fundus fluorescein angiography.
5. Subject must have a clinical indication for vitrectomy based on a diagnosis of one of the following conditions: vitreoretinal traction, asteroid hyalosis, macular pucker/epiretinal membrane, macular hole, or vitreous hemorrhage
6. Subject must have uncorrected visual acuity worse than 20/40 (Snellen) at Visit 1
|
|
| ExclusionCriteria |
| Details |
The patients will be excluded from the study based on the following exclusion criteria:
1. Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation.
2. Subjects with retinal disorders in the study eye that may confound interpretation of or prevent obtaining fundus fluorescein angiography (FA) or OCT images, including retinal vascular occlusion, choroidal neovascularization, macular atrophy or scarring, ocular histoplasmosis, or pathologic myopia.
3. Subjects who have had prior vitrectomy surgery, cryopexy, or retinal buckle procedure.
4. Subjects with prior history of retinal tear, vitreoretinal tractional detachment, or ocular tumors in either eye.
5. Subjects with visual acuity of No Light Perception at Visit 1.
6. Female subjects of child-bearing potential who have a positive urine test for pregnancy at Visit 1.
7. Subjects who have experienced any significant trauma in the operative eye within the past month.
8. Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
9. Subjects with history of complicated cataract surgery involving vitreous loss or a history of vitreoretinal surgery in the study eye.
10. Subjects with uncontrolled glaucoma or ocular hypertension (IOP > 24 mmHg) in the operative eye.
11. Subjects with dislocated lens or retained lens fragments.
12. Subjects with a known bleeding disorder or using drugs known to increase the likelihood of bleeding.
13. Subjects with uveitis refractory to treatment.
14. Subjects with significant anterior segment abnormality that would interfere with visualization of the vitreous or retina.
15. Subjects with a known allergy to sodium fluorescein dye.
16. Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator’s medical judgment, poses a concern for the subjects’ safety.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluate the performance quality of a study device for pars plana vitrectomy surgery.
Determine the range of time and device settings required to complete a vitrectomy
Assess surgeon assessed device adequacy for removal of core / peripheral vitreous, vitreous hemorrhage and for induction of PVD in subjects requiring the use of a vitrector
Verify no significantly different post surgical pathologic retinal changes due to study device
|
NA |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/07/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a single-arm, non-comparative, uncontrolled, open-label, monocular study to assess the safety and device performance of a hypersonic vitrector handpiece. Eligible subjects who are enrolled in the study will undergo a screening visit up to 14 days prior to surgery, a vitrectomy procedure in the study eye, and be clinically followed for 3 months after surgery. Enrolled subjects who meet eligibility criteria will be seen according to the following schedule: Pre-operative Visit Day -14 to -1 Operative Visit Day 0 Post-operative Visit 1 1 Day Post-operative Visit 2 7 Days +/- 2 days Post-operative Visit 3 30 Days +/- 7 days (interim observations) Post-operative Visit 4 90 Days +/- 14 days (final observations) |