| CTRI Number |
CTRI/2023/11/059906 [Registered on: 16/11/2023] Trial Registered Prospectively |
| Last Modified On: |
15/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to see the benefit of especially designed video game for the treatment of Children having Lazy Eyes and compare with the Standard Treatment. |
|
Scientific Title of Study
|
A Prospective, Randomized, Multicenter, Masked, Pivotal Study to Assess the Safety and Effectiveness of BYNOCS DAT (Dichoptic Amblyopia Training) Game in Treating Children with Amblyopia. |
| Trial Acronym |
N/A |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Virender Sachdeva |
| Designation |
Pediatric Ophthalmologist, Strabismus, Neuro- Ophthalmology |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute, GMRV Campus, Visakhapatnam, Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH
530040
India |
| Phone |
919605920647 |
| Fax |
|
| Email |
drvsachdeva29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virender Sachdeva |
| Designation |
Pediatric Ophthalmologist, Strabismus, Neuro- Ophthalmology |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute, GMRV Campus, Visakhapatnam, Andhra Pradesh, India.
Visakhapatnam
ANDHRA PRADESH
530040
India |
| Phone |
919605920647 |
| Fax |
|
| Email |
drvsachdeva29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Oliullah Abdal |
| Designation |
Director |
| Affiliation |
Kanohi Eye Private Limited |
| Address |
Kanohi Eye Private Limited,
Maryland Corner, TV Chidambaram Marg, Sion, Mumbai, Maharashtra, India.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
917498751001 |
| Fax |
|
| Email |
abdaloliullah@bynocs.com |
|
|
Source of Monetary or Material Support
|
| Kanohi Eye Private Limited |
|
|
Primary Sponsor
|
| Name |
Kanohi Eye Private Limited |
| Address |
Maryland Corner, TV Chidambaram Marg, Sion, Mumbai, Maharashtra, India. |
| Type of Sponsor |
Other [Device Manufacturer] |
|
|
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 |
| Dr Debasmita Majhi |
L V Prasad Eye Institute |
Mithu Tulsi Chanrai Campus, Patia
Khordha
ORISSA |
91-7978858456
drdebasmita@lvpei.org |
| Dr Sampada Kulkarni |
L V Prasad Eye Institute |
Kallam Anji Reddy Campus, L V Prasad Marg, Opposite PVR, Park View Enclave, Banjara Hills
Hyderabad
TELANGANA |
91-9916149164
sampada@lvpei.org |
| Dr Virender Sachdeva |
L V Prasad Eye Institute |
GMR Varalakshmi Campus,
Visakhapatnam
ANDHRA PRADESH |
91-9605920647
drvsachdeva29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Submittted/Under Review |
| L V Prasad Eye Institute Ethics Committee |
Submittted/Under Review |
| L V Prasad Eye Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H530||Amblyopia ex anopsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bynocs DAT (Dichoptic Amblyopia Training) Game |
Bynocs Dichoptic Amblyopia Training Game is a computer-based game with ability to adjust contrast of the stimulus of each eye, spatial frequency, temporal frequency, and the size of the target. Participant can play video games from his/her place of residence. |
| Comparator Agent |
Occlusion Therapy - Adhesive patch treatment |
Traditionally, the treatment for amblyopia involves patching the stronger eye to encourage the weaker eye to develop better vision. This method, known as occlusion therapy, has been the standard approach for many years. Participants in the standard of care treatment arm will wear an adhesive patch treatment. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 4 to less than 9 years boys and girls
2. Amblyopia associated with anisometropia (previously treated or untreated)
a) Criteria for anisometropia: At least one of the following criteria must be met:
Greater than or equal to 1.00 D difference between eyes in spherical equivalent.
Greater than or equal to 1.50 D difference in astigmatism between corresponding meridians in the two eyes.
b) Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
Greater than or equal to 1.00 D difference between eyes in spherical equivalent OR
Greater than or equal to 1.50 D difference in astigmatism between corresponding meridians in the two eyes.
3. Amblyopia associated with anisometropia, meeting at least one of the following conditions:
Newly diagnosed amblyopia (i.e., no prior treatment)
If there had been prior amblyopia treatment, it must have been discontinued with no treatment administered for not a minimum of 8 weeks prior to the Screening Visit.
4. Must have refractive error correction (based on a cycloplegic refraction completed within the last 7 months) if any of the following are true:
Hypermetropia of 2.50 D or more by spherical equivalent (SE)
Myopia of amblyopic eye of 0.50D or more SE
Astigmatism of 1.00D or more
Anisometropia of more than 0.50D SE.
NOTE: Participant with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigators discretion, but must follow the study specified prescribing guidelines, as detailed below.
a) Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:
SE must be within 0.50D of fully correcting the anisometropia.
SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
Axis must be within +/- 10 degrees if cylinder power is Less than or equal to 1.00D, and within +/- 5 degrees if cylinder power is Greater than 1.00D.
Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
b) Spectacle correction meeting the above criteria must be worn:
For at least 16 weeks OR until distance VA stability is documented (defined as Less than 0.1 log MAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
For determining VA stability (non-improvement):
The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
Note: since this determination is a pre study procedure, the method of measuring VA is not mandated.
5. VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ETDRS VA protocol.
a) Visual acuity in the amblyopic eye 20/32 to 20/200 inclusive
b) Best corrected dominant eye VA meeting 20/32 or better as per ETDRS VA protocol.
c) Interocular difference Greater than or equal to 2 log MAR lines.
6. Heterotropia with a near deviation of less than 5Δ (measured by SPCT) in habitual correction (Angles of ocular deviation Greater than 4Δ are not allowed because large magnitudes of the deviation would compromise successful alignment of the dichoptic stimuli.)
7. Participant is able to play Bynocs DAT game.
8. Participant and families eligible for clinic visits over duration of study.
9. Participant in general good health and able, as per investigator decision, to comply with study visits, protocol procedures, and wear refractive correction.
10. Participant has access to internet at home which is able to support the Bynocs DAT game.
11. Signed and dated informed consent form/assent form (if applicable).
12. Parent and participant understand and are willing to comply with study procedures and will be available for the duration of the study. |
|
| ExclusionCriteria |
| Details |
A Participant is excluded for any of the following reasons:
1. Myopia greater than -6.00 D. spherical equivalent in either eye.
2. Known skin reactions to patch or bandage adhesives.
3. Any other condition which could be a potential cause for reduced BCVA according to the investigator.
4. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
5. History of low adherence with amblyopia treatment as assessed informally by the investigator.
6. Participant that do not wear their spectacles. (as assessed by investigator)
7. History of light-induced seizures.
8. Wearing RGP (Rigid Gas Permeable) contact lenses.
9. Any reported anatomic ocular anomaly (e.g., small lens opacity, myelinated nerve fiber layer).
10. Previous intraocular or refractive surgery.
11. Any condition that prevents the Participant from completing a continues 40-60 min. of treatment per day while seating in front of a nearby screen.
12. Heterophoria with a total near deviation of Greater than or equal to 4Δ (measured by Simultaneous Prism Cover Test (SPCT)). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bynocs DAT game treatment to improve the visual acuity of amblyopia eye when compared to baseline as compared to standard of care arm. |
To investigate primary outcome results at 6, 12, 18 and or 24 weeks of BYNOCS DAT game treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether Bynocs DAT treatment leads to improvement in stereopsis and contrast sensitivity and reduce interocular suppression when compared to baseline and as compared to standard of care arm. |
To assess the secondary outcome results at 16 weeks. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
25/11/2023 |
| 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="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
|
This is 18 weeks prospective, randomized, multicenter, masked, pivotal study to investigate performance of Bynocs DAT game for Amblyopia treatment in 120 Participant in the age group of 4 to <9 years. Prospective amblyopic patients will be identified for the study by the study investigator/study team after the screening procedure and qualifying the study in-/exclusion criteria. Upon confirmation of eligibility, Participant will be individually randomized in the ratio 1:1. Participant in the intervention arm will be given Dichoptic Amblyopia Training which is a computer-based game with ability to adjust contrast of the stimulus of each eye, spatial frequency, temporal frequency, and the size of the target. Participant can play video games from his/her place of residence. The Participant will be undertaking a 60-minute session each day for 5 days a week under the supervision of their parents/guardian/care taker.
The total number of sessions to be covered in 18 weeks’ study duration are 90 of One hour each time.
Participant in the standard of care treatment arm will receive the adhesive patch treatment , which will be as follows:
BCVA 20/40 to 20/60: 2-hour patching for 7days a week for 18 weeks BCVA 20/60 to 20/100: 4-hour patching for 7days a week for 18 weeks BCVA worse than 20/100: 6-hour patching for 7days a week for 18 weeks.
The parents, guardian or care taker should supervise and assist the participant for this treatment as per doctor’s advice. On return of the participants for the follow-up visits, there should be a ‘masked observer’ who will assess the endpoint measurements and record the read-outs in the patient file. These readings will then be entered in the Electronic Case Report Forms (e-CRF). |