| CTRI Number |
CTRI/2025/09/095306 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
OPTICAL BIOMETERY IN CATARACT SURGERY:A COMPARATIVE STUDY OF AXIAL LENGTH MEASUREMENTS PRE AND POST CATARACT SURGERY |
|
Scientific Title of Study
|
COMPARISION OF AXIAL LENGTH MEASURMENT PRE AND POST CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION USING OPTICAL BIOMETER |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hardi pathak |
| Designation |
Post DO DNB |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
Sankara eye hospital sathy road near prozone mall saravanampatti siranandhapuram coimbatore tamil nadu
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9408998312 |
| Fax |
|
| Email |
hardi.pathak12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hardi pathak |
| Designation |
Post DO DNB |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
Sankara eye hospital sathy road near prozone mall saravanampatti siranandhapuram coimbatore tamil nadu
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9408998312 |
| Fax |
|
| Email |
hardi.pathak12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hardi pathak |
| Designation |
Post DO DNB |
| Affiliation |
Sankara Eye Hospital Coimbatore |
| Address |
Sankara eye hospital sathy road near prozone mall saravanampatti siranandhapuram coimbatore tamil nadu
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9408998312 |
| Fax |
|
| Email |
hardi.pathak12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hardi pathak |
| Address |
Sankara eye hospital sathy road near prozone mall saravanampatti siranandhapuram coimbatore tamil nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Hardi pathak |
Sankara Eye Hospital |
16-A, Sathy Rd, near Prozone Mall, Saravanampatti, Siranandha Puram, Coimbatore, Tamil Nadu 641035
Coimbatore
TAMIL NADU |
9408998312
hardi.pathak12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
patients aged above 18 years undergoing uncomplicated cataract surgery with iol implantation and willing to comply with follow up visitis |
|
| ExclusionCriteria |
| Details |
Eyes with previous intraocular surgery or trauma any posterior segment pathology or any complication during phacoemulsification |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative axial length measurments with preoperative values to determine any statistically significant changes |
To compare the postoperative axial length measurments with preoperative values to determine any statistically significant changes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/10/2025 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is comparision of axial length measurments obtained using an optical biometer before and after cataract surgery with intraocular lens implantation above 18years of age patients |