| CTRI Number |
CTRI/2025/11/097511 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Binasal Occlusion] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Binasal Occlusion effect on Refractive Errors Among Young Adult |
|
Scientific Title of Study
|
Effect of Binasal Occlusion on Refractive Errors Among Young Adult: A Comparative Study. |
| 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 |
Leas Institutional Research |
| Affiliation |
Sankara Eye Foundation |
| Address |
Sankara Eye Hospital Kundalahalli Signal, Varthur Main Road Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namratha |
| Designation |
Leas Institutional Research |
| Affiliation |
Sankara Eye Foundation |
| Address |
Sankara Eye Hospital Kundalahalli Signal, Varthur Main Road Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namratha |
| Designation |
Leas Institutional Research |
| Affiliation |
Sankara Eye Foundation |
| Address |
Sankara Eye Hospital Kundalahalli Signal, Varthur Main Road Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
9986266576 |
| Fax |
|
| Email |
namratha.hegde@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
KUNDALAHALLI SIGNAL, VARTHUR MAIN ROAD, BANGALORE 560037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Namratha |
Sankara Eye Hospital |
Department of Optometry, Sankara Eye Hospital Kundalahalli Signal, Varthur Main Road Bengaluru
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 |
| Healthy Human Volunteers |
REFRACTIVE ERROR |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BINASAL OCCLUSION |
BASELINE, 2 WEEKS AND 1 MONTH |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Spectacle wearer
Myopia (SE:less than -0.50D to -6.00D)
Hypermetropia (SE:more than +1.0D to +6.0D) |
|
| ExclusionCriteria |
| Details |
Strabismus
Diplopia
Neurological disease(TBI)
Amblyopia
Nystagmus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The quantitative change in refractive error (myopia or hyperopia) before and after the period of binasal occlusion, stratified by baseline refractive error type through retinoscopy and subjective acceptance.
|
baseline
2 weeks
1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze variations in visual symptoms before and after binasal occlusion therapy in individuals with different refractive errors post BNO.
To Analyze whether the magnitude or direction of refractive change differs between cohorts (myopia versus hyperopia).
|
baseline
2 weeks
1 month |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
28/11/2025 |
| 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)
|
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
|
Binasal
occlusion is a method of partial covering of the visual field of the two eyes
by placing of opaque tape on the nasal portion of the lenes. Peripheral awareness is ability to
simultaneously perceive what is center and appreciate what may or may not be
off to the sides. The aim of this study is to evaluate the effect of binasal
occlusion on changes in refractive status among young adults with varying
baseline refractive errors. Baseline evaluation included visual
acuity (VA), refraction, binocular vision (BV) evaluation, peripheral
awareness, and the Visual Symptom Questionnaire (COVD-QOL-19). Binasal
occlusion was applied for two weeks using micropore tape positioned just touching
the nasal limbus. After two weeks of binasal occlusion, post-occlusion
evaluation was performed, including VA, refraction, BV evaluation, peripheral
awareness, and the Visual Symptom Questionnaire (COVD-QOL-19). Follow-up
evaluation was conducted two weeks after discontinuing binasal
occlusion, using the same assessment parameters. Finally, data entry, analysis
and interpretation were carried out.
|