| CTRI Number |
CTRI/2023/08/056022 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the diffrence in postoperative astigmatism caused by phacoemulsification performed with 2.2mm and 2.8mm clear corneal corneal incision |
|
Scientific Title of Study
|
A Comparative study of post-operative astigmatism between 2.2mm and 2.8mm clear corneal incision in phacoemulsification |
| 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 Akshay Agarwal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Aarun Medical College And Rohilkhand Hospital |
| Address |
Department Of Ophthalmology Room No.227,Varun Arjun Medical College And Rohilkhand Hospital,Banthara,Shahjahanpur,Uttarpradesh-242307
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9674150636 |
| Fax |
|
| Email |
akshay.perfect087@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gireesh Mishra |
| Designation |
Head of Department |
| Affiliation |
Varun Arjun Medical College And Rohilkhand Hospital |
| Address |
Department Of Ophthalmology RoomNo.223 Varun Arjun Medical College And Rohilkhand Hospital,Banthara,Shahjahanpur,Uttarpradesh-242307
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9309825171 |
| Fax |
|
| Email |
gireeshmishra1960@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Agarwal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College And Rohilkhand Hospital |
| Address |
Room No. 50,Boys Resident Hostel Varun Arjun MEDICAL College And Rohilkhand Hospital,Banthara,Shahjahanpur,Uttarpradesh-242407
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9674150636 |
| Fax |
|
| Email |
akshay.perfect087@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College And Rohilkhand Hospital, Banthara,Shahjahanpur |
|
|
Primary Sponsor
|
| Name |
Dr Akshay Agarwal |
| Address |
Department Of Ophthalmology Room No.227 Varun Arjun Medical College And Rohilkhand Hospital,Banthara,Shahjahanpur,Uttarpradesh |
| 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 Akshay Agarwal |
Varun Arjun Medical College And Rohilkhand Hospital |
Room No. 227 OPD department of ophthalmology Varun Arjun Medical College And Rohilkhand Hospital,Banthara,Shahjahanpur Uttarpradesh
Shahjahanpur
UTTAR PRADESH |
9674150636
akshay.perfect087@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Varun Arjun Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H250||Age-related incipient cataract, (2) ICD-10 Condition: H259||Unspecified age-related cataract, (3) ICD-10 Condition: H259||Unspecified age-related cataract, (4) ICD-10 Condition: H259||Unspecified age-related cataract, (5) ICD-10 Condition: H269||Unspecified cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
postoperative astigmatism by 2.2mm clear corneal incision in phacoemulsification. |
postoperative astigmatism by 2.2mm clear corneal incision in phacoemulsification for wound stability and for speedier recovery |
| Intervention |
postoperative astigmatism by 2.8mm clear corneal incision in phacoemulsification |
postoperative astigmatism by 2.8mm clear corneal incision in phacoemulsification to reduce regular and irregular astigmatism. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
.Age Related Cataract
.Patient With No Systemic Illness
.Patient Without Any Corneal Abnormalities
.Patient With No Other Cause For Defective Vision,other Than Cataract
.Patient With No History Of Previous Ocular Surgery
|
|
| ExclusionCriteria |
| Details |
.Traumatic And Other Complicated Cataract
.Patient With SYSTEMIC Illness
.Patient With Defective Vision Other Than Catact
.PCIOL Implanted In Sulcus
.ACIOL Implantation
.Pre-Exsisting Significant Astigmatism Error
.Chronic Anterior Uveitis
.Glaucoma Filtration Surgery |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Differences In Postoperative Astigmatism Caused By Phacoemulsification Performed With 2.2mm And 2.8mm Clear Corneal Incision |
Day1,1 Week,1Month,3Month,6Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Outcome And Astigmatic Error Are Compared By Phacoemulsification With 2.2mm And 2.8mm Clear Corneal Incision |
Day1,1Week,1Month,3Month,6Month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/08/2023 |
| 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="0"
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
|
The Study " A Comparative Study Of Post-Operative Astigmatism Between 2.2mm And 2.8mm Clear Corneal Incision In Phacoemulsification" Will Be Conducted At The Department Of Ophthalmology,Varun Arun Medical College And Rohilkhand Hospital,Banthara,Shahjahanpur,Uttarpradesh Based On The Inclusion And Exclusion Criteriaa. A Total Of 100 Eyes Were Recruited And Then Seperated Into Two Groups Of 50 According To The Following Criteria: Group 1- Patient Underwent Phacoemulsification Through 2.8mm Clear Corneal Incision Group 2- Patient Underwent Phacoemulsification Through 2.2mm Clear Corneal Incision |