| CTRI Number |
CTRI/2024/08/071994 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to investigate the Efficacy, Safety, Acceptability of Essilor® Stellest® Spectacle Lenses along with the testing of Quality of Life implications in slowing down Myopia progression, in children and adolescents in India. |
|
Scientific Title of Study
|
A Multi-Centric, Retrospective, Real World Clinical follow-up study to demonstrate the Efficacy of Essilor® Stellest® Spectacle Lenses in slowing down Myopia progression in children and adolescents in India |
| Trial Acronym |
SOLIDITY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WS-10394, PRPL-SOLIDITY-01-2024, Ver 1.0 Dated 03-Jun-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Rohit Saxena |
| Designation |
Professor of Ophthalmology |
| Affiliation |
AIIMS |
| Address |
Room 135, First floor, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9868155230 |
| Fax |
|
| Email |
rohitsaxena80@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaya Vasanthakumar |
| Designation |
Medical & Professional Affairs Director |
| Affiliation |
Essilor® India Private Limited |
| Address |
45/14, Industrial Suburb, Opp. Tumkur Road, Yeshwanthpur
Bangalore
KARNATAKA
560022
India |
| Phone |
8197529017 |
| Fax |
|
| Email |
vijaya.v@essilorindia.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukul Maurya |
| Designation |
Director, ProClin Research Pvt Ltd |
| Affiliation |
ProClin Research Pvt Ltd |
| Address |
2nd floor, Plot no. 1, Nevri Hills, Gufa Mandir Road, Lalghati
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7032802286 |
| Fax |
|
| Email |
mukul@proclinresearch.com |
|
|
Source of Monetary or Material Support
|
| Essilor® India Private Limited, #45/14, Industrial Suburb, Opp.Tumkur Road, Yeshwanthpur, Bangalore, 560022 |
|
|
Primary Sponsor
|
| Name |
Essilor® India Private Limited |
| Address |
#45/14, Industrial Suburb, Opp.Tumkur Road, Yeshwanthpur, Bangalore, 560022 |
| Type of Sponsor |
Other [Opthalmic- Essilor® India Private Limited] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Rohit Saxena |
All India Institute of Medical Sciences |
Room 135, First floor, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, Delhi 110029
New Delhi
DELHI |
01126593182
rohitsaxena80@yahoo.com |
| Dr Sandra Ganesh |
Arvind Eye Hospital |
Myopia Clinic, Room no. 21 C, Basement floor, Civil AErodrome post Sitra,Avinashi Road, Coimbatore 641 014
Coimbatore
TAMIL NADU |
9894557363
drsandra77@gmail.com |
| Dr Jitendra Jethani |
Baroda Children Eye Care and Squint Clinic |
Second Floor, 212-213, Panorama Complex, RC Dutt Road, Alkapuri, Baroda, Gujarat 390007
Vadodara
GUJARAT |
9825560870
xethani@rediffmail.com |
| Dr Lipika Roy |
Centre for Vision & Eye Surgery |
1/398, 1st floor, Room No. 01, OMR Navalur, BMR Mall, Chennai 600130
Chennai
TAMIL NADU |
9566004668
lrlipikaroy@gmail.com |
| Dr Akshya |
Dr Agarwals Eye Hospital |
Chromepet No. 201, 1st Floor, GST Road, Chromepet, Chennai 600044
Chennai
TAMIL NADU |
9677036360
akshya07med@gmail.com |
| Dr Pavan Kumar Verkicharla |
L V Prasad Eye Institute |
Room No. 222A, GPR Building, 2nd Floor,Myopia Lab, Banjara Hills Road no. 2, Hyderabad 500034
Hyderabad
TELANGANA |
9573465443
pavanverkicharla@lvpei.org |
| Monica Chaudhry |
MC Vision Institute |
125/22 , Lower Ground, Mehrauli - Gurgaon Road , Block - C , Old DLF Colony, Sector 14, Gurugram 122001
Gurgaon
HARYANA |
9868762726
monica.rchaudhry@gmail.com |
| Dr Jyoti Matalia |
Narayana Netralaya |
G 11, OPD 3, Ground floor, Narayana Health City, Bangalore
Bangalore
KARNATAKA |
9341996565
jyotimatalia@gmail.com |
| Dr Prajna Ghosh |
Narayana Netralaya |
Ground floor,
No.63, Next to Royal Meenakshi Mall,
Bannerghatta Road, Hulimavu
Bangalore – 560 076
Bangalore
KARNATAKA |
7908745734
ghoshprajna@gmail.com |
| Dr Sumitha Muthu |
Narayana Netralaya |
B Block, 2nd Floor, 121/C, Chord Road, Rajaji Nagar 10th R Block, Bangalore 560 010
Bangalore
KARNATAKA |
8884550075
muthusumitha03@gmail.com |
| Dr Suraj Nayak |
Rajan Eye Care Hospital |
G-14(b), Ground floor, Room No. 5, Vidyodaya East 2nd street, T. Nagar, Chennai- 600 017
Chennai
TAMIL NADU |
8056109587
drsuraj25nayak@gmail.com |
| Dr Shalini Jain |
Samayk Eye Care Clinic |
First floor, Gaur Gravity Business Complex, Sec-4, Opp Chandra Laxmi Hospital, Vaishali, Ghaziabad 201010
Ghaziabad
UTTAR PRADESH |
9899960700
shalini59.sj@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee- Dr Akshya |
Submittted/Under Review |
| ACE Independent Ethics Committee- Dr Jitendra |
Submittted/Under Review |
| ACE Independent Ethics Committee- Dr Jyoti |
Approved |
| ACE Independent Ethics Committee- Dr Lipika |
Submittted/Under Review |
| ACE Independent Ethics Committee- Dr Prajna |
Approved |
| ACE Independent Ethics Committee- Dr Shalini |
Submittted/Under Review |
| ACE Independent Ethics Committee- Dr Sumitha |
Approved |
| ACE Independent Ethics Committee- Dr Suraj |
Submittted/Under Review |
| ACE Independent Ethics Committee-Dr Monica |
Submittted/Under Review |
| ACE Independent Ethics Committee-Dr Sandra |
Submittted/Under Review |
| AIIMS, New Delhi- Dr Rohit |
Approved |
| LV Prasad Eye Institute - Dr Pavan K Verkicharla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
1. Inclusion should be progressive myopia based on change in RE in the previous year
2. Information on progression of myopia prior to treatment should be available
3. All participants wearing Essilor® Stellest® Lenses |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare with change in SER over 1 year prior to use of Stellest lenses and Change in cycloplegic autorefraction (SER) from baseline upto 12 months |
Up to 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="395"
Sample Size from India="395"
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)
|
19/08/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Considering that, Myopia prevalence in urban India has been projected to spike to 48% by 2050. Myopia currently is widely recognized as a significant public health issue causing significant visual loss and a risk factor for a range of other serious ocular conditions. The prevalence of this condition is increasing on a global basis, for reasons that still are not understood. Although partial reductions in progression rates have been observed from pharmacologic therapies, optical treatments, and behavioural modifications (Interventions for Controlling Myopia Onset and Progression Report), we are a long way from being able to reverse the temporal trends of the last few decades. This makes myopia, and its associated complications, a high research priority. Many prospective studies have been done with Stellest® spectacle in other countries, which shows promising results in control of myopia progression. Therefore, it is imperative to determine whether Stellest® spectacle lenses can effectively reduce the progression of myopia in Indian children. In best of our knowledge, there has been no study done on Stellest® spectacle in Indian children. As the study is retrospective, consenting procedure is waived off. |