| CTRI Number |
CTRI/2025/12/099523 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
How psychological factors influence patients’ experience during vision therapy for binocular vision problems |
|
Scientific Title of Study
|
Psychological Mediators of Perceived versus Clinical Improvement in Non-Strabismic Binocular Vision Disorders (NSBVD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjani Raman |
| Designation |
Psychology Intern |
| Affiliation |
Sankara Eye Hospital |
| Address |
Psychology Department, First Floor, Room 4
Sankara Eye Hospital
Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura,
Kundalahalli, Munnekollal, Bengaluru, Karnataka – 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
7349103090 |
| Fax |
|
| Email |
ranjani.raman.01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranjani Raman |
| Designation |
Psychology Intern |
| Affiliation |
Sankara Eye Hospital |
| Address |
Psychology Department, First Floor, Room 4
Sankara Eye Hospital
Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura,
Kundalahalli, Munnekollal, Bengaluru, Karnataka – 560037
KARNATAKA
560037
India |
| Phone |
7349103090 |
| Fax |
|
| Email |
ranjani.raman.01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranjani Raman |
| Designation |
Psychology Intern |
| Affiliation |
Sankara Eye Hospital |
| Address |
Psychology department, First Floor, Room 4
Sankara Eye Hospital
Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura,
Kundalahalli, Munnekollal, Bengaluru, Karnataka – 560037
KARNATAKA
560037
India |
| Phone |
7349103090 |
| Fax |
|
| Email |
ranjani.raman.01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura,
Kundalahalli, Munnekollal, Bengaluru, Karnataka – 560037 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Gokul Ratakonda Chintamani |
Sankara Eye Hospital Bangalore |
Varthur Main Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA |
91 8069038900
bangalore@sankaraeye.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee of Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H511||Convergence insufficiency and excess, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 - 35 diagnosed with Non-Strabismic Binocular Vision Disorders (NSBVD)
Best corrected visual acuity: 6/6 (distance) and N6 (near) in each eye
Ability to understand and respond to self-report questionnaires in English
No history of strabismus, amblyopia, ocular/systemic pathology, or surgery affecting binocular vision
No significant anisometropia or medications influencing accommodation |
|
| ExclusionCriteria |
| Details |
Amblyopia, nystagmus, or ocular diseases (e.g., glaucoma, retinal pathology)
Neurological or systemic conditions affecting vision
Current or past psychiatric diagnosis that may impair questionnaire response |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To test a mediation model assessing how emotion regulation, rumination, and stress appraisal influence the link between objective clinical outcomes and patients’ perceived improvement after vision therapy. |
Baseline (pre-vision therapy) and post-therapy at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To quantify & describe levels of emotion regulation difficulties, rumination, & stress appraisal in patients with NSBVD using validated psychometric instruments. |
Baseline, pre vision therapy & post therapy at 8 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
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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="8"
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 is a prospective observational pre and post study conducted among adults diagnosed with Non Strabismic Binocular Vision Disorders. The study aims to understand why perceived improvement after routine vision therapy does not always match clinical improvement. Participants aged 18 to 35 years will undergo vision therapy as part of standard clinical care. They will complete questionnaires measuring perceived visual discomfort, emotion regulation, rumination and stress appraisal at baseline and or post therapy. Clinical procedures are not part of the research. The study will analyse whether psychological factors mediate the relationship between clinical improvement and perceived improvement. Findings may help explain individual differences in recovery experience and support a more patient centred approach to vision therapy.
|