| CTRI Number |
CTRI/2025/08/092491 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
We compare corneal size measured by IOL Master, Pentacam, and calipers, and study its relation to eye length and curvature. This helps identify the most reliable tool to guide lens selection and improve cataract surgery outcomes.
|
|
Scientific Title of Study
|
Comparison of WTW Corneal Diameter by IOL Master500,Pentacam & Digital Calipers & Its Biometric Correlation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEW ID |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chitransha Gaur |
| Designation |
PG Student |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Off GT Road,Amiliha,Post Office-Tatiyaganj,Kanpur Nagar
Off GT Road,Amiliha,Post Office-Tatiyaganj,Kanpur Nagar, Uttar Pradesh,209217
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
8889715647 |
| Fax |
|
| Email |
chitranshagaur24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Johri |
| Designation |
PG Student |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Off GT Road,Amiliha,Post Office-Tatiyaganj,Kanpur Nagar
Off GT Road,Amiliha,Post Office-Tatiyaganj,Kanpur Nagar, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
9839210684 |
| Fax |
|
| Email |
puneetjohri@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chitransha Gaur |
| Designation |
PG Student |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, Off GT Road,Amiliha,Post Office-Tatiyaganj,Kanpur Nagar
Off GT Road,Amiliha,Post Office-Tatiyaganj,Kanpur Nagar, Uttar Pradesh,209217
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
8889715647 |
| Fax |
|
| Email |
chitranshagaur24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital,Off GT Road,Amiliha,Post Office-Tatiyaganj, Kanpur Nagar,Uttar Pradesh,India, 209217 |
|
|
Primary Sponsor
|
| Name |
DrChitransha Gaur |
| Address |
Sankara Eye Hospital Off GT Road,Amiliha,Post Office,Tatiyaganj,Kanpur, Uttar Pradesh,India, 209217 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Chitransha Gaur |
Sankara Eye Hospital |
Room no.17, OPD
Kanpur Nagar
UTTAR PRADESH |
8889715647
chitranshagaur24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE-SANKARA EYE HOSPITAL KANPUR |
Approved |
| INSTITUTIONAL ETHICS COMMITTEESANKARA EYE HOSPITAL KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Comparing interchangeability of 3 modalities to measure wtw corneal diameter |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individual with age 20 and above
Optically clear cornea.
Cooperative subjects able to maintain fixation during all tests. |
|
| ExclusionCriteria |
| Details |
Patients with previous history of ocular surgery or trauma.
Any corneal pathology (e.g., keratoconus, dystrophies, degenerations)
Active contact lens use.
Active ocular infection or inflammation.
Systemic conditions of eye(connective tissue disorders)
Patients with poor fixation due to ocular or neurological causes (e.g., nystagmus, macular disease, advanced cataract, amblyopia, or cognitive impairment), leading to poor-quality scans or inability to complete standardized WTW measurements.
Severe ptosis or lid abnormalities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
WTW corneal diameter using IOL Master, Pentacam and Digital Caliper.
Biometric parameters like k1,k2, axial length and Anterior Chamber Depth using OL Master and Pentacam. |
WTW corneal diameter using IOL Master, Pentacam and Digital Caliper.
Biometric parameters like k1,k2, axial length and Anterior Chamber Depth using OL Master and Pentacam. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/08/2025 |
| 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="6"
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
|
This prospective cross-sectional observational study aims to compare white-to-white(WTW) corneal diameter measurements obtained using three modalities-Pentacam,IOL Master 500, and digital calipers-in healthy adults. The objective is to assess the agreement and correlation among these methods and evaluate their association with ocular biometric parameters such as axial length, anterior chamber depth, keratometry. By validating the accuracy of low-cost digital calipers against advanced imaging systems, the study explores the potential of their interchangeable use in routine clinical practice, especially in resource limited settings. |