| CTRI Number |
CTRI/2024/04/066063 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective observational study to observe the repeatability and reproducibility of device parameter] |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the accuracy of the measured parameters on the same eye captured multiple times using a single device of Elisars NOA (repeatability) and understand the accuracy of the measured parameter on the same eye using multiple devices of Elisars NOA (reproducibility) |
|
Scientific Title of Study
|
Protocol for Repeatability & Reproducibility of Elisars NOA |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Soundari |
| Designation |
Medical Director |
| Affiliation |
Dr Agarwals Eye Hospital |
| Address |
Room NO 217,
3rd floor,
Retina Department,
No 222
TTK Road
Alwarpet
Chennai
TAMIL NADU
600018
India |
| Phone |
9840339659 |
| Fax |
- |
| Email |
soundari404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Soundari |
| Designation |
Medical Director |
| Affiliation |
Dr Agarwals Eye Hospital |
| Address |
No 222
TTK Road
Alwarpet
TAMIL NADU
600018
India |
| Phone |
9840339659 |
| Fax |
- |
| Email |
soundari404@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Soundari |
| Designation |
Medical Director |
| Affiliation |
Dr Agarwals Eye Hospital |
| Address |
No 222
TTK Road
Alwarpet
TAMIL NADU
600018
India |
| Phone |
9840339659 |
| Fax |
- |
| Email |
soundari404@gmail.com |
|
|
Source of Monetary or Material Support
|
| Elisar Life Sciences Pvt Ltd,
1st floor, Buhari towers, No 4, Moores Road, Chennai - 600 006 |
|
|
Primary Sponsor
|
| Name |
Elisar Vision Technology |
| Address |
1st floor, Buhari Towers, No.4, Moores Road, Chennai - 600006 |
| Type of Sponsor |
Other [Medical Device Organization] |
|
|
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 S Soundari |
Dr Agarwals Eye Hospital |
Room NO 217, 3rd floor, Retina Department, No 222 TTK Road
Alwarpet, Chennai
TAMIL NADU - 600018
India
Chennai
TAMIL NADU |
9840339659
-
soundari404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Agarwals Eye Hospital IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, (2) ICD-10 Condition: H409||Unspecified glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Elisar-Novel Ophthalmic Analyzer |
Prospective observational study to observe the repeatability and reproducibility of device parameters. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
For Stage 1 Study
Controls
1. Patients said to be clinically normal by an ophthalmologist.
Cataract
1. Patients diagnosed with cataracts that are graded using the LOCS grading method by an ophthalmologist.
2. Eyes that are undergoing cataract surgery candidates in the clinic.
For Stage 2 Study
Controls
1. All subjects had no history of any ocular diseases, a fundus appearance should be normal.
Glaucoma
1. A definitive diagnosis of glaucoma, defined as glaucomatous visual field loss with an accompanying optic nerve abnormality typical of
glaucoma.
2. The glaucoma needed to be stable, and the patient required at least two reliable SITA Standard 24-2 HVF examinations. |
|
| ExclusionCriteria |
| Details |
For Stage 1 Study
1. Presence of keratoconus or suspect keratoconus, a previous diagnosis of dry eye, history of any corneal disease or trauma, any kind of ocular surgery, and use of contact lens past month.
2. Eyes with retinopathy or maculopathy, eyes with a history of corneal disease, pseudophakic eyes, Patients with corneal pathology, previous refractive surgery or abnormalities in the anterior segment.
For Stage 2 Study
Normal
1. a history of glaucoma or any other ocular disease or systemic diseases such as diabetes and images were also excluded if they had unusable OCT scans due to poor signal strength (less than 6) or
algorithm failure.
Glaucoma
1. any history of previous retinal disease such as macular degeneration or optic nerve disease, including non-glaucomatous optic neuropathy.
2. Both normal and glaucoma images were also excluded if they had unusable OCT scans due to poor signal strength (less than 6) or algorithm failure, in which the boundaries for the RNFL layer were not delineated correctly.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint of this study is to compare the repeatability and reproducibility of the biometry and OCT measurements in Elisar NOA by calculating the Standard deviation(SD) and limits for the repeated measurement and compare with the indicative limits. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
01/05/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Elisar’s NOA (Novel Ophthalmic Analyzer) is a device that is capable of performing anatomical measurements of an eye for artificial IOL power calculation and perform imaging of retinal layers. NOA is a versatile device that performs both the functions of Ocular biometry and OCT measurements of Retina. The gold standard for a device in clinical diagnosis is the ability of the device to produce repeatable and reproducible accurate results. Ocular biometry is the most important procedure in Cataract surgery as the biometry measurements are used to calculate the accurate Intraocular Lens power. OCT measurements of retinal layers aid in the diagnosis and treatment of different diseases. Thus it is important to produce a device that produces repeatable accurate measurements. The objective is to evaluate the repeatability & reproducibility of biometry and OCT
measurements in Elisar’s NOA that are acceptable and precise. This study is done in 2 stages, where stage 1 is for biometry measurement and stage 2 is for OCT measurements. Each stage has 3 phases that are Inter-device phase, the Intra-operator phase, Inter-operator phase. The result of this study is to match the repeatability and reproducibility measurement with the indicative limits that are considered from similar studies. |