| CTRI Number |
CTRI/2025/06/088239 [Registered on: 04/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing the efficacy of lens with highly aspherical lenslet for myopia control. |
|
Scientific Title of Study
|
Myopia control efficacy of Spectacle lenses with Highly aspherical lenslets (HAL) in high myopia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
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,
Room No: 222, Myopia lab, 2nd floor, GPR building,
Banjara Hills
Hyderabad
Telangana
India
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
pavanverkicharla@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Manisha Paudel |
| Designation |
Project Optometrist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Room No:222A, Myopia Research lab,2nd floor, GPR Building
Banjara Hills
Hyderabad
Telangana
India
Hyderabad
TELANGANA
500034
India |
| Phone |
6281845707 |
| Fax |
|
| Email |
manishapaudel32@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Paudel |
| Designation |
Project Optometrist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
Room No:222A, Myopia Research lab,2nd floor, GPR Building
Banjara Hills
Hyderabad
TELANGANA
500034
India |
| Phone |
6281845707 |
| Fax |
|
| Email |
manishapaudel32@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESSILOR International
Essilor R & D Centre
Singapore
201 Kallang Bahru #01-00
Essilor Luxottica Building
Singapore 339338 |
|
|
Primary Sponsor
|
| Name |
Essilor R & D Centre |
| Address |
201 Kallang Bahru #01-00 Essilor Luxottica Building
Singapore
Singapore 339338
|
| Type of Sponsor |
Other [Ophthalmic Optics Company] |
|
|
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 |
| DrPavan Verkicharla |
L V Prasad Eye Institute |
L V Prasad Eye Institute
Room No:222A, Myopia Research lab,2nd floor, GPR Building
Banjara Hills
Hyderabad 500034
Hyderabad
TELANGANA |
9573465443
pavanverkicharla@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
High Myopic children with single vision spectacles |
3 month, 6 months and 12 months |
| Intervention |
highly Aspherical lenslets |
3 month, 6 months and 12 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 6 to 14 years inclusive at time of enrolment
2.Interested in wearing spectacles for 5 days per week and 6 hours in a day
3.Best-corrected high contrast visual acuity based on manifest refraction of 0.18 logMAR
4.spherical equivalent-6.00 D to -11
5. astigmatic component 0 DC to -3.0DC
6.Spherical equivalent anisometropia less than or equal to 2.50 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 1500 gm at birth
3.Any ocular, systemic, or neuro-developmental conditions that may influence refractive error
4.Manifest strabismus (tropia)
5.Any known ocular inflammation or infection
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in axial length |
3 Months, 6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in spherical equivalent refractive error |
Base line, 3,6, 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/06/2025 |
| 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="1"
Months="1"
Days="1" |
|
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
|
This prospective 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.
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. Measurements will be obtained thirty
minutes after instillation of eye drops. Eligible participants will be called
for the dispensing visit and then
following study visits at 3 month, 6 months and 12 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, 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. |