| CTRI Number |
CTRI/2025/05/087401 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic Screening Other (Specify) [Quasi Experimental] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Study on the Effectiveness of Traditional vs. Online Eye Therapy for Adults with Focusing Difficulties |
|
Scientific Title of Study
|
Comparative Efficacy of Conventional Vision Therapy and Web-Based Vision Therapy in Managing Accommodative Inertia in Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niranjan Kumar |
| Designation |
Ph.D. Scholar |
| Affiliation |
Galgotias University |
| Address |
Room no- E-002, Department of Optometry, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
8826345789 |
| Fax |
|
| Email |
niranjankumar@galgotiasuniversity.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Partha Chowdhury |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room no- E-002, Department of Optometry, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9456771714 |
| Fax |
|
| Email |
partha.chowdhury@galgotiasuniversity.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Partha Chowdhury |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Room no- E-002, Department of Optometry, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 203201 India |
| Phone |
9456771714 |
| Fax |
|
| Email |
partha.chowdhury@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Galgotias University
Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh, India 203201 |
|
|
Primary Sponsor
|
| Name |
Niranjan Kumar |
| Address |
Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
| 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 Partha Chowdhury |
Eye OPD, Galgotias University |
Room no.- E-002, Department of Optometry, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 Gautam Buddha Nagar UTTAR PRADESH |
9456771714
partha.chowdhury@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H525||Disorders of accommodation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computer-Based Vision Therapy |
Participants will perform guided accommodative exercises through vision therapy software on a computer for 26 days. Exercises simulate accommodative challenges and track progress. Remote supervision/check-ins will be conducted weekly. |
| Comparator Agent |
Conventional Vision Therapy |
Participants will undergo supervised, clinic-based conventional vision therapy focused on accommodative training for 26 days, including lens flipper exercises, near-far charts, accommodative rock, and Hart chart tasks.
Conventional in-office vision therapy is the standard treatment modality for accommodative dysfunction and is being used as the reference arm to compare the efficacy and feasibility of computer-based and mobile app-based therapy interventions. |
| Intervention |
Mobile App-Based Vision Therapy |
Participants will use a mobile application designed for accommodative training, including gamified and interactive focusing tasks for 26 days. Weekly telephonic follow-up will be done to support adherence. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Young adults aged 18-30 years.
2. 6/6 Visual Acuity after correction
3. Diagnosed with accommodation dysfunctions based on clinical tests.
4. No prior vision therapy within the last six months.
|
|
| ExclusionCriteria |
| Details |
1. Significant ocular or systemic conditions affecting accommodation function.
2. History of ocular surgery or trauma affecting binocular vision.
3. Inability to provide informed consent or adhere to the study protocol.
4. Amblyopia or Suppression
5. Irlen Syndrome
6. Sjogren syndrome, Down syndrome |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Accommodative Facility |
At Baseline
Week 5
week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Accommodative Amplitude |
At Baseline
Week 5
Week 8 |
| Reduction in Visual Discomfort |
Baseline
Week 5
Week 8 |
| Adherence to Therapy Regimen |
Week 1 to Week 5
Final Adherence score- At end of Week 5 |
| User Satisfaction & Usability |
Week 5 only
|
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
14/06/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 quasi-experimental study aims to compare the efficacy of three different modes of vision therapy—conventional in-office therapy, computer-based therapy, and mobile app-based therapy—in improving accommodative facility and reducing visual discomfort in adults diagnosed with accommodative inertia. A total of three groups will receive structured vision therapy over a 6-week period, with each group undergoing a different mode of delivery. The conventional group will receive therapist-guided, in-person therapy using standard clinical techniques. The computer-based group will perform vision exercises via desktop software at home, while the mobile app group will use a smartphone-based platform designed for accommodative training.
Primary outcomes will include changes in accommodative facility, while secondary outcomes will assess improvements in accommodative amplitude, visual symptoms, therapy adherence, and user satisfaction. The study will also analyze compliance rates and user feedback to understand the feasibility and acceptability of digital therapy solutions. The findings are expected to guide clinicians in selecting personalized, effective, and scalable vision therapy modalities—particularly for individuals with lifestyle constraints or limited access to in-office therapy. This research supports the broader integration of digital therapeutics and tele-optometry into routine eye care. |