| 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
|
|
|
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
|
|
|
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. |