| CTRI Number |
CTRI/2025/10/095901 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [OFFICE BASED VISION THERAPY] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of manual versus software - based vision therapy in young adults having vision problems without squint. |
|
Scientific Title of Study
|
Efficacy of manual versus software - based vision therapy in young adults (aged 18-35 years) with non-strabismic binocular vision disorders- A Randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehil Sharma |
| Designation |
Junior Resident 1 |
| Affiliation |
Kalinga Institute Of Medical Sciences , Bhubaneswar |
| Address |
Department Of Ophthalmology , Kalinga Institute Of Medical Sciences , Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8209531472 |
| Fax |
|
| Email |
snehilsharma214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrutakirty Parida |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences , Bhubaneswar |
| Address |
Department Of Ophthalmology , Kalinga Institute Of Medical Sciences , Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8114918858 |
| Fax |
|
| Email |
shruti.bunty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shrutakirty Parida |
| Designation |
Assistant Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences , Bhubaneswar |
| Address |
Department Of Ophthalmology , Kalinga Institute Of Medical Sciences , Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
8114918858 |
| Fax |
|
| Email |
shruti.bunty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eye OPD , Department Of Ophthalmology , PBM Hospital , Kalinga Institute Of Medical Sciences , Campus-5 , KIIT Road , Patia , Bhubaneswar - 751024 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Snehil Sharma |
Ophthalmology department ,PBM Hospital , Kalinga Institute Of Medical Sciences, Bhubaneswar |
KIMS , Campus-5 , KIIT Road , Patia , Bhubaneswar
Khordha
ORISSA |
8209531472
snehilsharma214@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE , KIMS , BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H525||Disorders of accommodation, (2) ICD-10 Condition: H533||Other and unspecified disorders ofbinocular vision, (3) ICD-10 Condition: H511||Convergence insufficiency and excess, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
OFFICE BASED VISION THERAPY (MANUAL) |
Manual orthoptics therapy will be given for 10 consecutive days in phase 1 and then for another 10 consecutive days in phase 2 for 1hour/day with the help of accommodative flipper, life saver card, tranaglyph, loose lens rack, brockstring, aperture ruler and Synoptophore. We will assess the outcomes initially after 10 sessions (phase 1), then after 20 sessions (phase 2) and compare the outcomes in these two groups after each phase. |
| Intervention |
OFFICE BASED VISION THERAPY (SOFTWARE BASED) |
Software based vision therapy will be given for 10 consecutive days in phase 1 and then for another 10 consecutive days in phase 2 for 1hour/day with the help of VTS-4 software & its tool.We will assess the outcomes initially after 10 sessions (phase 1), then after 20 sessions (phase 2) and compare the outcomes in these two groups after each phase. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Young adults (aged 18-35 years) with non-strabismic binocular vision disorders
BCVA 6/6, N6
Good compliance with glasses or contact lenses
|
|
| ExclusionCriteria |
| Details |
Amblyopia (any form)
Presence of manifest/latent strabismus
History of prior ocular surgery or laser therapy
Any systemic disorder that affects accommodation and convergence
Nystagmus (manifest or latent)
Usage of medications that may impair accommodation or convergence
Patients lost to follow up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
We expect that software-based vision therapy will give better outcomes and better patient compliance as compared to manual vision therapy in young adults (18-35 years) with Non strabismic binocular vision disorders.
1. Subjective outcome based on CISS score
2. Objective outcomes based on accommodation and convergence facilities
|
The patients will be followed up after 1month, 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cost-effectiveness of each modality of vision therapy based on cumulative cost of each modality of therapy for 20 sessions in relation to the desired outcomes achieved. |
The patients will be followed up after 1month, 3 months & 6 months. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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="2"
Months="0"
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
|
Non-strabismic binocular
vision disorders (NSBVDs) encompass a group of visual disorders that affect how
the two eyes work together, leading to difficulties with binocular vision and
visual performance, especially when focusing on near objects, without any
misalignment of the eyes. Vision
therapy helps in improving the binocular vision parameters and provides
symptomatic relief to the patient. This is a RCT planned to be carried out in
the department of ophthalmology, PBMH, KIMS, Bhubaneswar for a period of 2
years to compare the efficacy of manual versus software - based vision therapy
in young adults (aged 18-35 years) with non-strabismic binocular vision
disorders. After
a detailed orthoptic assessment, one group will be treated with manual vision
therapy and the other group with software - based vision therapy for 10
consecutive days and then again for another 10 consecutive days for 1hour/day.
Assessment will be done at the end of each phase and outcomes will be compared. |