| CTRI Number |
CTRI/2025/07/091396 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare the efficacy of myopia control spectacle lenses and low dose atropine eye drops as monotherapy and in combination in arresting the progression of near sightedness (myopic spectacle power) in Indian children. |
|
Scientific Title of Study
|
Defocus Spectacles with 0.01 percent atropine eye drops for slowing myopia, a randomized controlled trial. |
| 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 Rimsha Parvez |
| Designation |
Postgraduate resident |
| Affiliation |
Jupiter Hospital |
| Address |
Department of Ophthalmology, Jupiter Hospital, Service road, Eastern Express Highway, next to Viviana mall, Thane
Thane
MAHARASHTRA
400601
India |
| Phone |
9011559786 |
| Fax |
|
| Email |
rimshaparvez2701@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mihir Kothari |
| Designation |
Pediatric Ophthalmologist |
| Affiliation |
Jupiter Hospital |
| Address |
Department of Ophthalmology, Jupiter Hospital, Service road, Eastern Express Highway, next to Viviana mall, Thane
Thane
MAHARASHTRA
400601
India |
| Phone |
9324037173 |
| Fax |
|
| Email |
drmihirkothari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mihir Kothari |
| Designation |
Pediatric Ophthalmologist |
| Affiliation |
Jupiter Hospital |
| Address |
Department of Ophthalmology, Jupiter Hospital, Service road, Eastern Express Highway, next to Viviana mall, Thane
MAHARASHTRA
400601
India |
| Phone |
9324037173 |
| Fax |
|
| Email |
drmihirkothari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Essilor® India Private Limited, #46, 10th floor, Prestige Trade Tower, Palace road, High Grounds, Sampangi Rama Nagar, Bengaluru, Karnataka, India-560001
|
|
|
Primary Sponsor
|
| Name |
Dr Rimsha Parvez |
| Address |
Department of Ophthalmology, Jupiter Hospital, Service road, Eastern Express Highway, next to Viviana mall, Thane, Maharashtra- 400601 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rimsha Parvez |
Jupiter Hospital |
Jupiter Netralay, Service road, Eastern Express Highway, next to Viviana mall, Thane, Maharashtra
Thane
MAHARASHTRA |
9011559786
rimshaparvez2701@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JH Institutional Ethics Committee |
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 |
HALT spectacles |
Stage 1: The patient after fulfilling the inclusion criteria is recruited
One of his/her eyes will be randomized using block randomization of block size 6 To receive combination therapy (defocus spectacles spectacles
+ atropine eye drops)
The other eye will receive monotherapy (defocus spectacles)
Stage 2: After 4 months, a cross-over in the treatment methods between the two eyes will be done.
In the eye with combination therapy, atropine eye drops will be tapered and stopped according to the universal guidelines. In the eye with monotherapy will now receive combination therapy.
Stage 3: After further 4 months, both the eyes will only be treated with defocus
spectacles.
Stage 4: After further 4 months, the treatment with defocus spectacles will also be stopped to evaluate for rebound myopia.
|
| Comparator Agent |
low dose atropine eye drops (0.01 percentage concentration) |
Stage 1: The patient after fulfilling the inclusion criteria is recruited One of his/her eyes will be randomized using block randomization of block size 6 To receive combination therapy (defocus spectacles spectacles + atropine eye drops) The other eye will receive monotherapy (defocus spectacles) Stage 2: After 4 months, a cross-over in the treatment methods between the two eyes will be done. In the eye with combination therapy, atropine eye drops will be tapered and stopped according to the universal guidelines. In the eye with monotherapy will now receive combination therapy. Stage 3: After further 4 months, both the eyes will only be treated with defocus spectacles. Stage 4: After further 4 months, the treatment with defocus spectacles will also be stopped to evaluate for rebound myopia |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Magnitude of myopia ranging from -1d to -8d ser in each eye.
Astigmatism less than -4d in each eye.
Documented progressive myopia with an increase of more than or equal to 0.5d ser in each eye in the previous year.
Children whose parents or guardian are willing to give a written informed consent.
|
|
| ExclusionCriteria |
| Details |
Children with any ocular or systemic co-morbidities.
Children with history of frequent eye rubbing.
Children who have best corrected visual acuity of less than or equal to 6 by 12 on Snellens chart.
Children having an inter-acuity difference of more than or equal to 2 lines on Snellens chart.
Myopia progression in the last year of less than -0.5d ser in either eye.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Spherical Equivalent Refraction |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Axial length |
4 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/08/2025 |
| 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="4"
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
|
This is a prospective, randomized controlled cross-over trial evaluating the efficacy of Highly Aspherical Lenslet Target (HALT) defocus spectacles, both as monotherapy and in combination with low-dose atropine (0.01 percentage) eye drops, in controlling childhood progressive myopia in Indian children aged 6–14 years. The study follows a four-phase sequential design over 24 months:
Phase 1: One eye receives combination therapy (HALT + atropine), the other receives monotherapy (HALT).
Phase 2: Cross-over; monotherapy eye starts atropine, combination eye undergoes tapering.
Phase 3: Both eyes continue with HALT spectacles only.
Phase 4: Complete cessation of treatment in both eyes to assess for rebound myopia.
The primary outcome measures include change in axial length and cycloplegic spherical equivalent refraction. This study will help determine the relative effectiveness and sustainability of combination versus monotherapy in myopia control.
Primary Purpose of the Study:
To compare the effectiveness of HALT defocus spectacles alone versus in combination with low-dose atropine eye drops (0.01 percentage) in slowing childhood myopia progression, and to assess the short-term rebound effects after treatment cessation.
Study Hypothesis:
Combination therapy using HALT spectacles and low-dose atropine is more effective than HALT monotherapy in reducing myopia progression. Additionally, rebound myopia following withdrawal is expected to be less significant in eyes previously treated with combination therapy. |