| CTRI Number |
CTRI/2025/06/088043 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A gentle eye massage can improve eye health and reduce eye problems. |
|
Scientific Title of Study
|
Effect of Manual Eye Massage on Myopic Patients - A Pre-Post 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 Sneha Bharti |
| Designation |
Lecturer |
| Affiliation |
Swami Vivekanand Subharti University, Meerut, U.P. |
| Address |
Maharishi Aurobindo Subharti College & Naturopathy of Naturopathy & Yogic Sciences Swami Vivekanand Subharti University Meerut Uttar Pradesh Hno 13 Kumkum colony Merawal Sindoor Sindur Hazaribagh Jharkhand 825301 Meerut UTTAR PRADESH 250005 India |
| Phone |
9538447592 |
| Fax |
|
| Email |
snehabhartisingh02@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sneha Bharti |
| Designation |
Lecturer |
| Affiliation |
Swami Vivekanand Subharti University, Meerut, U.P. |
| Address |
Maharishi Aurobindo Subharti College & Naturopathy of Naturopathy & Yogic Sciences Swami Vivekanand Subharti University Meerut Uttar Pradesh Hno 13 Kumkum colony Merawal Sindoor Sindur Hazaribagh Jharkhand 825301
UTTAR PRADESH 250005 India |
| Phone |
9538447592 |
| Fax |
|
| Email |
snehabhartisingh02@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sneha Bharti |
| Designation |
Lecturer |
| Affiliation |
Swami Vivekanand Subharti University, Meerut, U.P. |
| Address |
Maharishi Aurobindo Subharti College & Naturopathy of Naturopathy & Yogic Sciences Swami Vivekanand Subharti University Meerut Uttar Pradesh Hno 13 Kumkum colony Merawal Sindoor Sindur Hazaribagh Jharkhand 825301
UTTAR PRADESH 250005 India |
| Phone |
9538447592 |
| Fax |
|
| Email |
snehabhartisingh02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sneha Bharti |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Meerut Uttar Pradesh |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self funded |
Maharishi Aurobindo Subharti College & Hospital of Naturopathy & Yogic Sciences Swami Vivekanand Subharti University Meerut Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sneha Bharti |
Chhatrapati Shivaji Subharti Hospital |
Swami Vivekanand Subharti University Meerut 250005 Meerut UTTAR PRADESH |
9538447592
snehabhartisingh02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethical Committee (Medical) Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Manual Eye Massage |
Procedure of eye Massage Close the patient s eyes then place the thumbs tip
on the upper eyelid while the hands fingers are placed on the temples just
above the orbit Gently rotate while gradually raising the pressure being
careful that it doesnt become too high and hurt Patients with poor eye sight
frequently say that following the application their vision has improved |
| Comparator Agent |
Not Applicable |
pre-post trail |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers with no existing medical conditions except Myopia Subjects who are willing to participate in the study after signing the informed consent form |
|
| ExclusionCriteria |
| Details |
Pathological Myopia Subjects under the influence of any psychoactive substances sedatives anxiolytics anti depressants and consuming alcohol and nicotine Subjects having systemic illness and co morbidity such as epilepsy CVD Cancer Tuberculosis Pyrexia due to any reason |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Retinoscopy
Autorefractometer |
baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
12/06/2025 |
| 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="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
Modification(s)
|
Myopia Short-sightedness is the most common visual disability in the world The definition of myopia is an objective refractive error of at least 0 5 D in either eye corresponding to the spherical equivalent of myopia Two types of myopia are known as simple or school myopia Less than equal to 6 dioptres and high or pathological myopia greater than 6 dioptres Simple myopia can be corrected with spectacles or contact lenses but high myopia can lead to blinding conditions such as macular degeneration retinal detachment and glaucoma In 2010 1 45 billion people or 27 of the world s population were affected by myopia which is the most common cause of distance refractive error globally In India 5 to 15 year old urban children s prevalence of myopia grew from 4 44 in 1999 to 21 15 in 2019 Our forecasts show that the prevalence of myopia will rise to 31 89 in 2030 40 01 in 2040 and 48 14 in 2050 based on the slope of 0 8 every year 4 05 every five years In the following Three decades there will be an overall increase in myopia prevalence across all age groups of 10 53 due to the generational effect induced by the condition s lifetime prevalence 2020 to 2050 The scientific methodical manual or mechanical manipulation of the body s soft tissues for therapeutic purposes is known as massage therapy Prenatal depression preterm infants full term infants autism skin conditions pain syndromes like arthritis and fibromyalgia hypertension autoimmune conditions like asthma and multiple sclerosis immune conditions like HIV and breast cancer and ageing issues like Parkinson s and dementia have all been shown to benefit from massage therapy Although majority of the studies compared massage therapy to control groups receiving conventional care several of them compared various types of massage eg Swedish versus Thai massage Donders was the first to recommend massage for the eyes Eye massage has been reported to be helpful in the early stages of glaucoma hypopyon and corneal ulceration and cloudiness The vascularity and drainage of the eyes are both increased by massage Reimbmayr observed that massaging one eye caused the other to become dilated for the first minute contract for the second and then become smaller than the other eyes pupil in the third demonstrating that massage of the eye affects the controlling nerve centres in addition to the eye itself through reflex action Applying massage to the eyes requires a very high level of touch delicacy Patient eye sight is impaired often remark that they are able to see better after the application However no research paper has been done to see the Effect of Manual Eye Massage on Myopic Patients. Thus this study aims to understand the hypothesis of J H Kellogg MD in his Book the Art of massage Manual eye Massage improve the eye sight So that the mechanism of manual eye massage have to be found Data collection has been started. |