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CTRI Number  CTRI/2025/10/096095 [Registered on: 15/10/2025] Trial Registered Prospectively
Last Modified On: 14/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Uncorrected Refractive Errors Among Patients in a Tertiary Health Care Centre in Coimbatore. 
Scientific Title of Study   Screening for Pattern of Uncorrected Refractive Errors Among Patients in a Tertiary Health Care Centre in Coimbatore: a Cross-sectional 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  Mathan G  
Designation  MBBS Student 
Affiliation  KMCH Institute of Health Sciences and Research 
Address  Department of Ophthalmology, A block, 3rd floor, Room no: North 8, KMCH Institute of Health Sciences and Research, 99, Civil Aerodrome Avinashi Road, Coimbatore.

Coimbatore
TAMIL NADU
641014
India 
Phone  7339290844  
Fax    
Email  nsgmathan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nithyapriya C  
Designation  MS(Ophthalmology) 
Affiliation  KMCH Institute of Health Sciences and Research 
Address  Assistant Professor, Department of Ophthalmology, A block, 3rd floor, Room no: North 8, KMCH Institute of Health Sciences and Research, 99, Civil Aerodrome Avinashi Road, Coimbatore

Coimbatore
TAMIL NADU
641014
India 
Phone  9994996391  
Fax    
Email  svnithyapriya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nithyapriya C  
Designation  MS(Ophthalmology) 
Affiliation  KMCH Institute of Health Sciences and Research 
Address  Assistant Professor, Department of Ophthalmology, A block, 3rd floor, Room no: North 8, KMCH Institute of Health Sciences and Research, 99, Civil Aerodrome Avinashi Road, Coimbatore

Coimbatore
TAMIL NADU
641014
India 
Phone  9994996391  
Fax    
Email  svnithyapriya@gmail.com  
 
Source of Monetary or Material Support  
KMCH Institute of Health Sciences and Research, Coimbatore. 641014 
 
Primary Sponsor  
Name  Mathan G  
Address  KMCH Institute of Health Sciences and Research, Coimbatore. 641014 
Type of Sponsor  Other [Investigator initiated ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mathan G  KMCH Institute of Health Sciences and Research  Department of Ophthalmology, A block, 3rd floor, Room no: North 8, No:99, Civil Aerodrome Avinashi Road, Coimbatore , TamilNadu, India. 641014 Coimbatore TAMIL NADU
Coimbatore
TAMIL NADU 
7339290844

nsgmathan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H527||Unspecified disorder of refraction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients of age above 18 of both the sexes reporting to OPD at KMCH IHSR 
 
ExclusionCriteria 
Details  Patient with 6/6 best corrected visual acuity (BCVA) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Uncorrected refractive errors among patients are reported  2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Better treatment methodology is suggested in advance and prevents the progression of disease   2 months 
 
Target Sample Size   Total Sample Size="194"
Sample Size from India="194" 
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)   03/11/2025 
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="0"
Months="2"
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  
1.Adult patients reporting with Uncorrected Refractive Errors to the Department of Ophthalmology will be undertaken as subjects for the cross-sectional study.
2.Visual acuity testing will be done for patients using Snellen’s Chart for distant vision and Jaeger’s Chart for near vision, following detailed examination of eye will be done to rule out causes of visual impairment other than refractive errors.
3.Patients who have difficulty reading 6/6 and N/6 will be evaluated under an auto-refractometer, and after cycloplegic instillation they will be examined under a streak retinoscope, followed by slit lamp examination and indirect ophthalmoscope examination to rule out other defects in the anterior and posterior segment, respectively.
4.Following appropriate protocol, ensuring quality control, and assessing through standard calibrated instruments, refractive error findings will be recorded and categorized. Data will be collected and recorded with the help of various statistical tools.
5.Through maintaining confidentiality and following ethical principles, the data will be collected from the patient population and made to analyze, categorize according to varying refractive errors.
6.Refractive errors like myopia, hypermetropia, and astigmatism will be segregated in groups. A proportion of these uncorrected refractive errors in the patient population from a tertiary health care centre will be reported.
 
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