| CTRI Number |
CTRI/2025/08/092220 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
To detect dry eye problems among the patients with non squint binocular vision anomalies |
|
Scientific Title of Study
|
Dry Eye Disease among the patients with Non Strabismic Binocular Vision Anomalies |
| 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 Namratha |
| Designation |
Associate Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Dept. of optometry, Sankara eye hospital, Varthur main road, Kundanhalli Signal, Bangalore.
Dept. of Optometry, Sankara eye hospital, Varthur main road, Kundanhalli signal, Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namratha |
| Designation |
Associate Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Dept. of optoemtry,Sankara College of Optometry, Sankara eye hospital, Varthur main road, Kundalahalli, Bangalore.
Dept. of Optometry, Sankara College of Optometry, Sankara eye hospital, Varthur main road, Kundalahalli, Bangalore
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha |
| Designation |
Associate Professor |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara eye hospital, Varthur main road, Lakshminarayanapura, Kundanhalli, Bangalore.
Sankara eye hospital, Varthur main road, Lakshminarayanapura, Kundanhalli, Bangalore.
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Varthur main road, Lakshminarayanapura, Kundanhalli
Bangalore 560037, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Varthur main road, Lakshminarayanapura, Kundalahalli
Bangalore 560037 Karnataka India |
| 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 |
| Namratha |
Sankara Eye Hospital |
Sankara Eye Hospital, Varthur main road, Lakshminarayanapura, Kundanhalli
Bangalore
Bangalore
KARNATAKA |
9986266576
namratha.hegde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H049||Disorder of lacrimal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
BCVA of 0.00 log Mar for distance and N6 for near
Patients diagnosed with NSBVA |
|
| ExclusionCriteria |
| Details |
Known case of Dry eye on treatment
Known case of MGD on treatment
Patients with history of ocular surgeries - refractive, post cataract and squint surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between severity of NSBVA and Dry eye Symptoms |
At baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation the Clinical test results & questionnaire between NSBVA & Dry Eye |
At baseline only |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
14/08/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study includes the patients with age group of 19- 40 years having best corrected vision of 0.00 logMar for distance and N6 for near, It excludes patients having dry eye and MGD on treatment and any kind of ocular surgery (refractive, post cataract, and squint) . The base line evaluation is done which includes history, visual acuity and refraction following the NSBVA work up evaluating sensory ,motor, accommodative and vergence test. The dry eye evaluation includes keratograph, schimer’s , anterior chamber and TBUT. The study participants will be given a questionnaire of NSBVA and Dry Eye (COVD and OSDI). Dry eye symptoms among NSBVA patients are correlated through clinical test results and symptom score for better intervention and speed recovery. |