| CTRI Number |
CTRI/2025/12/099253 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Eye Changes Seen In People With High Levels Of Nearsightedness |
|
Scientific Title of Study
|
A Clinical Study On Ocular Parameters In High Myopia Patients |
| 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 Anshool Kumbhare |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,sawangi, Wardha |
| Address |
Department of Ophthalmology ,Ground floor,AVBRH building,Sawangi,Meghe wardha, Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9834497650 |
| Fax |
|
| Email |
kumbhareanshool@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Daigavane |
| Designation |
Professor and HOD of Department of Ophthalmology |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,sawangi, Wardha |
| Address |
Department of Ophthalmology ,Ground floor,AVBRH building,Sawangi,Meghe wardha, Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
09021736568 |
| Fax |
|
| Email |
hod.ophthalmologyjnmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Daigavane |
| Designation |
Professor and HOD of Department of Ophthalmology |
| Affiliation |
Datta Meghe Institute of Higher Education and Research,sawangi, Wardha |
| Address |
Department of Ophthalmology ,Ground floor,AVBRH building,Sawangi,Meghe wardha, Maharashtra 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
09021736568 |
| Fax |
|
| Email |
hod.ophthalmologyjnmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,Sawangi,Wardha,India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research,Sawangi,Wardha,Maharashtra,India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Anshool Anil Kumbhare |
Acharya Vinoba Bhave Rural Hospital |
Room number 24,Department of Ophthalomology,groung floor,AVBRH building,Sawangi Meghe ,Wardha ,Maharashtra
Wardha
MAHARASHTRA |
9834497650
kumbhareanshool@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institunal Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
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 |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having high myopia
2.Participants who will give the informed consent |
|
| ExclusionCriteria |
| Details |
1.Patients with hypermetropia
2.Patients with corneal lesions & lens defects.
3.Patients with uveitis & infections of the eye
4.Patients which will not be willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know the multitude of known and emerging ocular changes within the high myopia
patients |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study changes in fundus & axial length in high myopia patients.
2.To evaluate keratometry , corneal thickness & astigmatism in high myopia patients.
|
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/02/2026 |
| 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
|
A cross-sectional study assessing ocular changes in high myopia patients . Conducted at JNMC, Wardha, over 2 years with 140 participants aged 10–50 years. Examinations include refraction, A-scan, pachymetry, keratometry, and fundus evaluation. The study aims to correlate ocular parameters like axial length, corneal thickness, and astigmatism with the degree of myopia to aid in early detection and management of complications |