| CTRI Number |
CTRI/2025/03/081813 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two types cuts made in eye operation |
|
Scientific Title of Study
|
Efficacy of chevron versus frown incisions and surgically induced astigmatism in Small Incision Cataract Surgery |
| 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 Kunal Bhat |
| Designation |
Postgraduate student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology,Ground floor,AVBRH building,Sawangi,Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9205307787 |
| Fax |
|
| Email |
kunal.bhat020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Daigavane |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology,Ground floor,AVBRH building,Sawangi,Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021736568 |
| Fax |
|
| Email |
drsachin391977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Daigavane |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology,Ground floor,AVBRH building,Sawangi,Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9021736568 |
| Fax |
|
| Email |
drsachin391977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research,Sawangi,Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi,Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Kunal Bhat |
Acharya Vinobha Bhave Rural Hospital |
Room number 24,Department of Ophthalmology, ground floor,
AVBRH building, Sawangi,Meghe
Wardha
MAHARASHTRA |
9205307787
kunal.bhat020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Research Committee |
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 |
Chevron incision |
A Chevron incision will be made for scleroconreal tunnel in SICS. Visual acuity will be assessed after 1 month. |
| Comparator Agent |
Frown incision |
A frown incision will be made for scleroconreal tunnel in SICS. Visual acuity will be assessed after 1 month. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having uncomplicated bilateral or unilateral senile cataract with grade 2-5 nuclear sclerosis or white cataracts.
2.Patients with no other cause for defective vision other than cataract
3.Patients with no history of previous ocular surgeries in the operating eye.
4.Patients with preoperative astigmatism less than 1 D. |
|
| ExclusionCriteria |
| Details |
1.Patients with ocular pathologies including complicated, congenital and traumatic cataracts.
2.Patients with astigmatism with more than 1 D.
3.Patients having immature cataracts associated with ocular comorbidities,injury or surgery.
4.Patients having operative complications(nucleus drop,PCR) or any systemic disorder(Diabetes, Hypertension).
5.Cases with premature entry or where valve cannot be formed properly.
6.Patients unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A significant difference is expected in the efficacy of the chevron v/s frown incisions & the resultant surgically induced astigmatism in the small incision cataract surgery. |
15 days and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="2"
Months="0"
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
|
The purpose of the study is to know the efficacy of Chevron v/s Frown incision along with the surgically induced astigmatism in the small incision cataract surgery (SICS). 116 patients (58 in each group) [Group C & Group F] who reported to the Department of Ophthalmology, Acharya Vinobha Bhave Rural Hospital, Sawangi taken up in a two-arm parallel interventional study which will be conducted for a time duration of 2 years. The demographic data along with other pre-clinical data will be collected on the proforma. The surgical intervention will be done & the data will be collected on the EXCEL sheet & required statistical test will be carried out. A significant difference is expected in the efficacy of the chevron v/s frown incisions & the resultant surgically induced astigmatism in the small incision cataract surgery. |