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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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