| CTRI Number |
CTRI/2024/08/072260 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A single-centre study to check the visual performance and reduction in farsightedness in children with use of DIMSHYP spectacle lenses |
|
Scientific Title of Study
|
A single-centre, prospective, randomized, single-masked, controlled clinical trial to evaluate the DIMSHYP spectacle lenses visual performance and reduction of hyperopia in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DIMSHYP-2024-001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Triveni Venkat |
| Designation |
Consultant Ophthalmologist |
| Affiliation |
Dr Agarwals Eye Hospital |
| Address |
Room no. 3, Department of Ophthalmology, Ground Floor, Dr. Agarwal’s Eye Hospital Limited, TT Krishnamachari Road, Near Raj Park Hotel Alwarpet, Chennai, Tamil Nadu, India. 600018.
Chennai
TAMIL NADU
600018
India |
| Phone |
9444703553 |
| Fax |
|
| Email |
trivivenkat@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Triveni Venkat |
| Designation |
Consultant Ophthalmologist |
| Affiliation |
Dr Agarwals Eye Hospital |
| Address |
Room no. 3, Department of Ophthalmology, Ground Floor, Dr. Agarwal’s Eye Hospital Limited, TT Krishnamachari Road, Near Raj Park Hotel Alwarpet, Chennai, Tamil Nadu, India. 600018.
TAMIL NADU
600018
India |
| Phone |
9444703553 |
| Fax |
|
| Email |
trivivenkat@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Triveni Venkat |
| Designation |
Consultant Ophthalmologist |
| Affiliation |
Dr Agarwals Eye Hospital |
| Address |
Room no. 3, Department of Ophthalmology, Ground Floor, Dr. Agarwal’s Eye Hospital Limited, TT Krishnamachari Road, Near Raj Park Hotel Alwarpet, Chennai, Tamil Nadu, India. 600018.
TAMIL NADU
600018
India |
| Phone |
9444703553 |
| Fax |
|
| Email |
trivivenkat@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dr. Agarwal’s Eye Hospital Limited, TT Krishnamachari Road, Near Raj Park Hotel Alwarpet, 600018, Chennai, Tamil Nadu,
India.
|
|
|
Primary Sponsor
|
| Name |
Dr. Agarwal’s Eye Hospital Limited |
| Address |
TT Krishnamachari Road, Near Raj Park Hotel Alwarpet, Chennai, Tamil Nadu, India. 600018 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Triveni Venkat |
Dr.Agarwals Eye Hospital |
Ground Floor, TT Krishnamachari Road, Near Raj Park Hotel Alwarpet, Chennai, Tamil Nadu, India. 600018
Chennai
TAMIL NADU |
9444703553
trivivenkat@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Agarwal’s Eye Hospital-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H533||Other and unspecified disorders ofbinocular vision, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DIMSHYP spectacle lenses |
All study spectacle lenses will be available in +2.00 D to +6.50 D sphere with up to 1.50 D of cylinder. for 24 months |
| Comparator Agent |
Single vision spectacle lens. |
All study spectacle lenses will be available in +2.00 D to +6.50 D sphere with up to 1.50 D of cylinder for 24 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects’ age at time of parent (or guardian) consent and subject assent: 6 -9 years old.
2. Subjects with cycloplegic autorefraction SER between +2.00 D and +6.50 D.
3. Subjects with cycloplegic autorefraction astigmatism of 1.50 D or less.
4. Subjects with cycloplegic autorefraction anisometropia of 1.50 D or less.
5. Subjects with monocular best-corrected distance visual acuity (BCDVA) under cycloplegic equal to or better than logMAR 0.08 (better than 20/25).
6. Subjects in which baseline 3D macula optical coherence tomography (OCT) volume scan can clearly measure sub-foveal choroidal thickness.
7. Subjects and parents (or LAR) are able and willing to provide oral/verbal assent and consent, respectively.
8. Subjects and parents (or LAR) assure to attend required study visits and adhere to participant requirements.
9. The parent (or LAR) understands and accepts random allocation of grouping, and the subject and parent (or LAR) will not know the allocated group.
10. Subjects are willing to wear the study spectacle lens for a minimum of 12 hours per day for the duration of the study
|
|
| ExclusionCriteria |
| Details |
1. Subjects with an allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops.
2. Subjects with any ocular and systemic abnormalities that might be expected to affect visual functions or refractive development.
3. Subjects with prior treatment of hyperopic control six months prior to the screening.
4. Subjects with clinically significant strabismus orbinocular vision abnormalities
5. Subjects with amblyopia or history of amblyopia.
6. Subjects with previous intraocular surgery.
7. Subjects with participation in a clinical trial within 30 days before the study entry into this study.
8. Subjects with presence of any emotional, physiologic or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment, based on the clinical judgment of the investigator.
9. Subjects with any medical treatment or medication which might influence the vision or interfere with study assessments.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of the DIMSHYP spectacle lens on visual performance and in refractive correction in non-diseased, non-amblyopic hyperopic children over a period of up to 24 months. |
Baseline and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the reduction of hyperopia with DIMSHYP spectacle lens in non-diseased, non-amblyopic hyperopic children over a period of up to 24 months. |
Baseline and 24 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/08/2024 |
| 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="3"
Months="0"
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
|
India has a high burden of refractive errors
(REs), including hyperopia, among school-going children. The overall prevalence
of RE per 100 children is 8.0 and in schools it is 10.8. The population-based
prevalence of hyperopia is 4.0%. Uncorrected and under corrected REs can affect
a child’s academic performance, social participation, and future economic productivity. RE correction improves
educational outcomes but has not distinguished the type of RE. Hyperopic
correction improves accommodative performance for sustained reading tasks for
the majority of participants. RE correction with Defocus Incorporated Multiple
Segments (DIMS) spectacle lenses produces significant improvement in Visual
Acuity (VA). DIMS spectacle lenses have good tolerance and acceptability.
Moreover, DIMS spectacle lenses produce significantly better outcomes than
single vision (SV) spectacle lenses and result in sustained long-term
improvement. However, these findings are restricted to children with myopia,
and effect of DIMS spectacle lenses in school going children with hyperopia
remains to be determined. |