| CTRI Number |
CTRI/2024/09/073247 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [spectacles] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
New Spectacle glass films with S.T.O.P technology to help slow down near sightedness (Myopia)in kids aged 6 to 14 years |
|
Scientific Title of Study
|
Spectacle films utilizing S.T.O.P.® technology for slowing down myopia progression in children: A prospective, masked, controlled, randomized, clinical trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nthal2021-04,version 1, 14 April 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPavan Verkicharla |
| Designation |
scientist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg, GPR Building, 2nd floor, Room No: 222A, Myopia Research Lab,Banjara Hills, Road No:02, Hyderabad 500034, Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9573465443 |
| Fax |
|
| Email |
pavanverkicharla@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPavan Verkicharla |
| Designation |
scientist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg, GPR Building, 2nd floor, Room No: 222A, Myopia Research Lab,Banjara Hills, Road No:02, Hyderabad 500034, Telangana
TELANGANA
500034
India |
| Phone |
9573465443 |
| Fax |
|
| Email |
pavanverkicharla@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Maanila Pajanivelou |
| Designation |
Project Optometrist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg, Banjara Hills, Road No:02, Hyderabad 500034, Telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9489807636 |
| Fax |
|
| Email |
maanila.pajanivelou@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute
L V Prasad Marg,
Banjara Hills, Road No:02,
Hyderabad 500034,
Telangana, India |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg, Banjara Hills, Road No:02, Hyderabad 500034, Telangana |
| Type of Sponsor |
Other [Not for profit] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrUday Gajiwala |
Divyajyoti Trust Tejas Eye Hospital |
Suthar Falia, Opposite to hanuman temple, At&Po, Mandvi district, surat, Gujarat
Surat
GUJARAT |
9979461646
divyajyoti.icare@gmail.com |
| DrPavan Verkicharla |
L V Prasad Eye Institute |
L V Prasad Eye Institute
L V Prasad Marg,Myopia Research lab, Room No: 222A,2nd floor,GPR Building, Banjara Hills, Road No:02, Hyderabad 500034, Telangana
Hyderabad
TELANGANA |
9573465443
pavanverkicharla@lvpei.org |
| DrCJagadesh Reddy |
Pristine Eye Hospital |
Summit Space, Opposite to mind space, Next to HP fuel station, Madhapur, Hyderabad
Hyderabad
TELANGANA |
9885696678
jagadeshreddy@pristineeyehospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Aster Prime Hospital |
Submittted/Under Review |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
| Institutional Ethics Committee,Divya Jyoti Trust |
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 |
| Comparator Agent |
Active_Comparator- intervention 1 |
Single vision spectacle lens |
| Comparator Agent |
Active_comparator-Intervention 4 |
Static optical signal_single vision spectacle lens + S.T.O.P spectacle film in between approximately 2 months |
| Intervention |
Experimental- Intervention 5 |
Dynamic Optical Signal_Single vision Spectacle lens+S.T.O.P kit 1 or Kit 2 for last 18 months |
| Intervention |
Experimental-Intervention 2 |
Single vision spectacles plus S.T.O.P kit 1 for first 6 months |
| Intervention |
Experimental-Intervention 3 |
single vision spectacle + S.T.O.P kit 2 for first 6 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 6 – 14 years inclusive at time of enrolment
2.Interested in wearing spectacles for 5 days/week and 6 hours/day
3.Best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye.
4.Willing to swap the spectacle lenses as per the study requirements.
5.-5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS.
6.-1.50 DC ≤ astigmatic component ≤ 0 DC.
7.Spherical equivalent anisometropia ≤ 1.00 D
|
|
| ExclusionCriteria |
| Details |
1.Current or prior use of any form of myopia control strategy.
2. Participant born earlier than 30 weeks or weighed less than 1500gm at birth.
3.Any ocular, systemic or neuro developmental conditions that may influence refractive error.
4.Manifest strabismus.
5.Any known ocular inflammation or infection. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Stage 1: To demonstrate superiority in reducing the rate of myopia progression as measured by the change axial length between each test and the control.
Stage 3: To compare the rate of myopia progression as measured by axial length between S.T.O.P.® films used with a dynamic optical signal against a static optical signal.
|
1 month, 4 months, 6 months, 12 months and 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stage 1: To compare the change in cycloplegic spherical equivalent autorefraction and visual performance (subjective data and visual acuity) between each test and control.
Stage 3: To compare the change in cycloplegic spherical equivalent autorefraction and visual performance between S.T.O.P.® films used with a dynamic optical signal against a static optical signal.
|
42 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/09/2024 |
| 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="3"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This prospective randomized controlled clinical
trial will be conducted in Myopia Research Lab, L V Prasad Eye Institute, Hyderabad,
and the study protocol will adhere to the tenets of Declaration of Helsinki. This
study will be conducted in 3 stages. Participants will be recruited based on
the inclusion and exclusion criteria either from The Infor Myopic Clinic, L V
Prasad Eye Institute, Hyderabad or by advertisement in local media (newspaper),
or approaching schools for referrals. An informed consent will be obtained from
each participant (parent/guardian of participating child) after explaining the
nature of the study. Assent will be obtained from the participating children.
Detailed ocular and medical history will be elicited followed by comprehensive
examination (visual acuity, slit lamp examination, open-field autorefraction,
subjective refraction), pupillometry, specialty tests such as binocular vision
assessments, axial length measurement, peripheral refraction, optical coherence
tomography, corneal topography. All participants will undergo cycloplegic
refraction after instillation of Tropicamide 1% eye drops. Eligible and willing
participant will be sequentially randomized into either one of the two test
groups or control group: Control (Single Vision Spectacles); S.T.O.P.®® Kit 1 (AF+30/AF+30
& AF-30/AF-30); S.T.O.P.® Kit 2 (AF+30/AF+30
& AE-30/AE-30). Each S.T.O.P.® kit comprises two
pairs of spectacles and each pair of spectacles of each S.T.O.P.® kit has a
different pair of spectacle films, i.e., varying in design and/or orientation,
applied to them. The participant will then be called for dispensing visit and
then following study visits at 1 month, 4 months and 6 months. Stage 2 will
commence at the conclusion of the Stage 1 at 6 months visit, and participants
will wear lenses with AF180 bilaterally. Stage 3 will commence when the Stage 1
analysis is complete, and the participant is re-randomized into one of two
interventions: Dynamic (Best performer: S.T.O.P.® Kit 1 or S.T.O.P.® Kit
2) and Static (AF+30/AF+30). The participant will then be called for study
visits at 6 months, 12 months, and 18 months. In each follow-up visits, the
required ocular parameters such as visual acuity, slit lamp examination, axial
length, peripheral refraction, open field autorefraction, subjective refraction
(if change in spectacle power is indicated), pupillometry, optical coherence
tomography, corneal topography along with participant’s compliance to the
spectacles provided will be assessed to analyze the efficacy of these
spectacles in controlling myopia progression. |