| CTRI Number |
CTRI/2021/04/033167 [Registered on: 27/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Vision therapy for amblyopia in older children and adults |
|
Scientific Title of Study
|
Vision therapy for amblyopia in older children and adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Savleen Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Dr Savleen Kaur
Room No 116
Advanced Eye Centre
Post Graduate Institute of Medical Education and Research
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
017227561111 |
| Fax |
|
| Email |
mailsavleen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savleen Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Dr Savleen Kaur
Room No 116
Advanced Eye Centre
Post Graduate Institute of Medical Education and Research
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
27561111 |
| Fax |
|
| Email |
mailsavleen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savleen Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Dr Savleen Kaur
Room No 116
Advanced Eye Centre
Post Graduate Institute of Medical Education and Research
Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
27561111 |
| Fax |
|
| Email |
mailsavleen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research, Research Grant Cell, Sector 12, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research Research Grant Cell |
| Address |
Post Graduate Institute of Medical Education and Research, Research Grant Cell, Sector 12, Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SAVLEEN KAUR |
Post Graduate Institute of Medical Education and Research |
Room no 116
Department of Ophthalmology (Advanced Eye Centre)
Chandigarh
CHANDIGARH |
017227561111
mailsavleen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER |
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 |
Perceptual Learning Therapy |
Treatment arm will receive 40 computerized training sessions. Each session takes approximately 30 minutes to complete. The sessions would be performed in sequence, every 2 days totaling 3-4 sessions per week spanning over 2-3 months. |
| Comparator Agent |
The gold standard treatment for amblyopia that is patching of the sound eye |
All patients will be continued on part-time occlusion of the dominant eye with an adhesive patch; 6 hours/day for moderate to severe amblyopia. There will be followed up at 6 weekly intervals for 3 months for documentation and ensuring compliance. |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
ALL TYPES OF Amblyopic patients presenting between 9 to 30 years will be recruited |
|
| ExclusionCriteria |
| Details |
Patients with diplopia/epilepsy/chronic migraines/pregnancy/attention disorder. Patients who have received any pharmacotherapy in past/present for amblyopia. Patients who fail to complete the required follow up or do not complete therapy will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Best corrected visual acuity |
6 months and one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stereopsis and Contrast Sensitivity testing |
6 months and one year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="21" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2021 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mailsavleen@gmail.com].
- For how long will this data be available start date provided 02-01-2023 and end date provided 07-01-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Amblyopia is a decreased visual acuity without any identifiable
organic cause in the eye. It is the main cause of poor unilateral vision in
children and believed to occur during a period of neural plasticity early in
life. Traditional amblyopia treatment is based on depriving the ‘‘good†eye
while optimizing the visual experience of the amblyopic eye mainly by
occlusion. The benefit of patching fades as the child grows and there is
currently no treatment available to successfully treat amblyopia in a child more
than 9 years. In children more than 10 years only one-quarter–one-half of children responding to
combined treatment of spectacles and patching.
Recent
studies suggest that repetitive practice can improve performance on a variety
of visual tasks in adult humans with normal visual capacities. Studies on
perceptual learning indicate that practice can result in improvement of many
visual tasks in adults, including visual detection or discrimination of
orientation, Vernier offset, stereo information, and contrast sensitivity
function. Our hypothesis is that perceptual learning will modify visual
functions in even adult patients of amblyopia and improve visual acuity,
contrast and stereopsis in these patients. The aim of our study is to assess
the efficacy of perceptual learning exercises in older children and adults with
amblyopia who have failed patching.
|