| CTRI Number |
CTRI/2019/11/022048 [Registered on: 18/11/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study to determine equivalence and precision of measurement parameters in ophthalmic images obtained from PRIMUS 300 and CIRRUS 5000 HD OCT imaging devices. |
|
Scientific Title of Study
|
Comparison of macular thickness, ganglion cell analysis (GCA), retinal nerve fiber layer (RNFL) thickness and optic nerve head (ONH) measurements of PRIMUS 300 and CIRRUS HD-OCT, Model 5000 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CARIn-02-2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sribhargava Natesh |
| Designation |
Consultant Vitreoretinal and Director |
| Affiliation |
Nethra Eye Hospital |
| Address |
Vitreous and Retina Division, Retina Dept., No. 8, Poojary Layout, 80 Ft Road, RMV II Stage, Bangalore
Bangalore
KARNATAKA
560094
India |
| Phone |
080-23512666 |
| Fax |
|
| Email |
sribhargava.natesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T C Ganesh Babu |
| Designation |
Head of Clinical & Regulatory Affairs |
| Affiliation |
Carl Zeiss India (Bangalore) Pvt Ltd |
| Address |
Plot no. 3, Jigani Link Road, Bommasandra Industrial Area, Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
9880225622 |
| Fax |
|
| Email |
ganesh.babu@zeiss.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T C Ganesh Babu |
| Designation |
Head of Clinical & Regulatory Affairs |
| Affiliation |
Carl Zeiss India (Bangalore) Pvt Ltd |
| Address |
Plot no. 3, Jigani Link Road, Bommasandra Industrial Area, Bangalore
Bangalore
KARNATAKA
560099
India |
| Phone |
9880225622 |
| Fax |
|
| Email |
ganesh.babu@zeiss.com |
|
|
Source of Monetary or Material Support
|
| CARIn Division. Carl Zeiss India Pvt Ltd., Plot No 3 Jigani Link Road Bommasandra Industrial Area, Bangalore - 560099 |
|
|
Primary Sponsor
|
| Name |
Carl Zeiss India Pvt Ltd |
| Address |
Plot No 3 Jigani Link Road Bommasandra Industrial Area Bangalore 560099 |
| Type of Sponsor |
Other [Medical Device Industry - Global] |
|
|
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 Sribhargava Natesh |
Nethra Eye Hospital |
Vitreous and Retina Division, Retina Dept., Room No. 8, Poojary Layout, 80 Ft Road, RMV II Stage, Bangalore - 560 094
Bangalore
KARNATAKA |
080-23512666
sribhargava.natesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal subjects, Subjects with known retinal disease and Subjects with glaucoma of any type |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CIRRUS HD-OCT Model 5000 |
The CIRRUS HD-OCT Model 5000 is a non-contact, high resolution tomographic and
biomicroscopic device for imaging the anterior and posterior segments of the eye. It is a Class II medical device that has received 510(k) clearance from the United States FDA
(K111157, K083291, K063378 K150977; K181534) and is commercially released. |
| Intervention |
PRIMUS 300 HD OCT |
The PRIMUS 300 is an ophthalmologic instrument, a class II medical device that provides functionality similar to CIRRUS 400, but with a separate manual patient interface. The high resolution of retinal cross-sectional image is acquired by utilizing spectral domain optical coherence tomography, a non-invasive, non-contact low-coherence interferometry technique. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
For inclusion, as normal subject, both eyes (OD & OS) must fulfill all of the following
criteria
1.Males or females 18 years of age or older
2. No history and evidence of retinal pathology or glaucoma
Inclusion criteria: Retinal disease subjects (any eye OD or OS must meet any of the
criteria)
1.Males or females 50 years of age or older with diagnosis of active or recurrent neovascular age-related macular degeneration with presence of either drusen, pigment epithelial detachment or choroidal neovascularisation
2.Males or females 18 years of age or older with diagnosis of persistent diabetic macular
edema or cystoid macular edema or proliferative diabetic retinopathy
3.Males or females 18 years of age or older, with diagnosis of macular hole or vitreomacular
traction
4. Males or females 18 years of age or older with diagnosis of either sub-retinal fluid
(neurosensory detachment), subretinal hemorrhage, intraretinal atrophy, RPE disruption and tear, lamellar holes, exudates, fibrotic disciform scar, ischemic tissue, intra-retinal hemorrhage, vitreous hemorrhage, vascular occlusive disease, central serous retinopathy, epiretinal membranes, or other retinal disease
Inclusion criteria: Glaucoma Subjects (any eye, OD or OS)
1.Males or females 18 years of age or older, with a diagnosis of glaucoma of any type,
ranging from early to advanced stage |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1. Best spectacle corrected visual acuity worse than 20/40 in either eye (normal subjects
only)
2.Inability to clinically view the optic discs due to media opacity or poorly dilating pupil
3.Unable to understand and follow the instructions on study procedures
4. Unable to cooperate for study procedures, specifically in terms of fixation
5.Unable to sit upright in front of the device
6.Presence of tremor, pathological rotational nystagmus and dyspnea
7. Any active infection of anterior or posterior segments
8.Unable to return for the required study visits |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the equivalence of the means of 26 measurement parameters: macular thickness (9 parameters), ganglion cell analysis (7 parameters), RNFL thickness (5 parameters), ONH measurements (5 parameters), between PRIMUS 300 and CIRRUS 5000 for the purpose of reusing CIRRUS reference database |
4 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the repeatability and reproducibility of PRIMUS 300 macular thickness,
ganglion cell analysis, RNFL thickness & ONH measurements |
4 Months |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable. This study has not been submitted for publication and hence mentioned as "Not Applicable" in publication section. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
OBJECTIVES: 1. To evaluate the equivalence of the means of 26 measurement parameters: macular thickness (9 parameters), ganglion cell analysis (7 parameters), RNFL thickness (5 parameters), ONH measurements (5 parameters), between PRIMUS 300 and CIRRUS 5000 for the purpose of reusing CIRRUS reference database 2. To determine the repeatability and reproducibility of PRIMUS 300 macular thickness, ganglion cell analysis, RNFL thickness & ONH measurements
Study Design & Overview This is a prospective single centre, comparative study and will undergo approval process by study independent ethics committee, prior to study initiation.
Informed consent will be obtained after explaining the nature and purpose of study. Any further study related procedures will be undertaken after obtaining informed consent from the subjects.
The study will include a total of 165 eligible subjects. Both normal subjects & subjects with ocular disease will be enrolled in this study. A previous diagnosis of retinal disease or glaucoma will be noted as part of the study procedures. Subjects may undergo the study site’s standard practice of clinical and eye examination procedures on the same date as their study visit, but is not a requirement. The subjects will be evaluated for eligibility and study enrollment within 3 study groups, normal, retinal disease & glaucoma.
For a subject with no known retinal disease or glaucoma, both the eyes (OD & OS) will be scanned. The assignment of scan type for the eyes (OD/OS), either macular cube scans or RNFL/ONH scans and acquisitions on the study devices will be as per the randomization table. For a subject with known retinal disease, the study eye (OD/OS) will be assigned by the Investigator based on the disease findings and macular cube scans will be acquired only on the study eye. Scan acquisitions using the study devices will be as per the randomization table. For a subject with known glaucoma, the study eye (OD/OS) will be assigned by the Investigator based on the disease findings and GCA & RNFL/ONH scans will be acquired only on the study eye. Scan acquisitions using the study devices will be as per the randomization table.
Data collected in the study will be used to evaluate the equivalence of the means of 26 measurements, for the purpose of reusing the CIRRUS reference database. Three (3) PRIMUS 300 devices, one (1) CIRRUS 400 device and three (3) OCT operators with varied expertise will be involved in the study. All study activities will be performed in a single visit but scanning may be performed on an optional 2nd visit if necessary.
All the enrolled subjects with retinal disease and glaucoma will be managed for the condition as per the study site’s standard practice. The specific study procedures will have no influence on the decision making and disease management process practiced at the site.
Target population Normal male and female subjects and subjects with known retinal disease and glaucoma of any type ranging from early to advanced stage, aged ≥ 18 years.
Statistical Methods
Agreement Analyses: For each macular thickness, ganglion cell analysis and RNFL/ONH parameter, the mean across different devices and operators will be calculated for the first measurement from each study eye for PRIMUS 300 and CIRRUS 5000
Transferring CIRRUS 5000 Reference Database: After comparing individual study eye groups for agreement, the normal eye group and retinal disease eye group will undergo a combined regression analysis to determine the appropriate conversion of CIRRUS 5000 reference data to apply to PRIMUS 300 data for macular thickness measurements. The normal eye group and glaucoma eye group will undergo a combined regression analysis to determine the appropriate conversion of CIRRUS 5000 reference data to apply to PRIMUS 300 data for MTA, GCA, RNFL and ONH measurements.
Repeatability and Reproducibility: An analysis of variance (ANOVA) model will be used to estimate the repeatability and reproducibility of the parameters for PRIMUS 300. |