| CTRI Number |
CTRI/2024/04/066295 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Data Collection |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare anatomical measurements of eye that is used to calculate the power of Intra-ocular Lens (IOL) measured by Elisars NOA. |
|
Scientific Title of Study
|
Protocol for Comparison of ocular biometry measurements in NOA and IOLMaster 500. |
| 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 116, First Floor,
Glaucoma 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 |
Room 116, First Floor,
Glaucoma department,
No 222 TTK Road Alwarpet
Chennai
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 |
Room 116, First Floor,
Glaucoma department,
No 222 TTK Road Alwarpet
Chennai
TAMIL NADU
600018
India |
| Phone |
9840339659 |
| Fax |
- |
| Email |
soundari404@gmail.com |
|
|
Source of Monetary or Material Support
|
| Elisar Life Science Pvt Ltd
Room 116, First Floor,
Glaucoma department,
No 222 TTK Road Alwarpet,
Chennai - 600018 |
|
|
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Soundari |
Dr Agarwals Eye Hospital, Tamabaram |
Room No 10, Scan Room,
T.D.K Tower, No 6, Duraiswamy Reddy Street, West Tambaram, Near Tambaram Bus Stop, Chennai, Tamil Nadu 600045
Chennai
TAMIL NADU |
9840339659
soundari404@gmail.com |
| Dr S Soundari |
Dr Agarwals Eye Hospital, Velachery |
Room No.3, Scan Room,
Old Survey No.465/2,
R.S. 465/8, 150 Feet Bypass Road, Next to NAC Jewellers, Velachery,
Chennai
TAMIL NADU |
9840339659
soundari404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr Agarwals Eye Hospital IEC |
Approved |
| 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Visual acuity as tested within one week of the trial should be better than 6/18 will be selected for the study.
2. One eye of each patient should be selected by either randomly or the eye operated first.
Inclusion for Controls
1. Patients said to be clinically normal by ophthalmologist.
Inclusion for Cataract
1. Patients diagnosed with cataract graded using the LOCS grading method by ophthalmologist.
2. Eyes that are undergoing cataract surgery candidates in the clinic |
|
| ExclusionCriteria |
| Details |
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.
3. Patients with corneal pathology, previous refractive surgery or abnormalities in the anterior segment. |
|
|
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 ocular biometry measurements captured by Elisar NOA and IOLMaster 500 device. The measured values will be compared with the limits indicated in the protocol. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary endpoint of this study is to compare the predicted refractive error for the calculated IOL power of each patient in both Elisar NOA and IOLMaster 500 where the difference in the error is not more than 1D. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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)
|
15/05/2024 |
| 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 the eye for artificial IOL power calculation
and performing imaging of retinal layers. NOA is a versatile device that performs both
the functions of Ocular biometry and OCT measurements of Retina. Normal and Cataract eyes will be diagnosed by the ophthalmologist based on the
following tests
1. Slit-lamp examination
Presence of cataracts will be judged by an ophthalmologist and marked
against the LOCS grading method. Also, to make sure that no other
abnormal findings are present in the anterior segment of the eye.
2. Fundus examination
The presence of normal posterior segment and with normal cup-disc ratio will
be defined by the ophthalmologist and the patient will be recruited under
Normals and Cataract eyes. The objective of this study is to evaluate the comparison of the ocular biometry measurements
and the effectiveness of the Elisar NOA device against the existing device in the market (IOLMaster
500). The study includes Cataract eyes of 200 and 75 eyes of Healthy Controls for comparison of the biometry measurements. To show the agreement between Elisar’s NOA and IOLMaster 500, bland-altman plots will be plotted against the measured values, and the values are expected to be within the indicative limits that are captured from the similar studies. |