| CTRI Number |
CTRI/2025/03/082782 [Registered on: 19/03/2025] 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 of two types blocks during eye operation. |
|
Scientific Title of Study
|
Comparative study To evaluate pain And surgical outcomes between topical Vs sub Tenons Anaesthesia In Manual Small Incision Cataract Surgery At Tertiary Rural Care Hospital |
| 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 Suyash Singh |
| 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 |
9222729075 |
| Fax |
|
| Email |
suyashsingh9990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Tidake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, ground floor, AVBRH building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887476011 |
| Fax |
|
| Email |
drpravinktidake75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravin Tidake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Ophthalmology, ground floor, AVBRH building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887476011 |
| Fax |
|
| Email |
drpravinktidake75@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 Suyash Singh |
Acharya Vinobha Bhave Rural Hospital |
Department of Ophthalmology, ground floor, AVBRH building, Sawangi, Meghe
Wardha
MAHARASHTRA |
9222729075
suyashsingh9990@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: O||Medical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sub tenon anaesthesia |
A blunt cannula will used to administer anesthetic agent in sub tenons space, so as to provide anesthesia for a period of 30 minutes surgery. |
| Intervention |
Topical anaesthesia |
A anesthetic drops will used to directly over the eye so as to provide anesthesia for a period of 30 minutes surgery. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having uncomplicated bilateral or unilateral Senile Cataract with grade 2 to 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 surgery in the operating eye.
4. Patients who gave their consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with other ocular pathologies including Complicated, Congenital and Traumatic cataracts, Retinal diseases.
2. Patients having immature cataracts associated with other ocular comorbidities, injury, or surgery
3. Patients having operative complications like nucleus drop, PCR or any systemic disorders.
4. Cases with premature entry or where valve could not be formed properly.
|
|
|
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 findings between the pain & surgical outcomes between the topical v/s Sub tenon’s anaesthesia in the MSICS is expected. |
Assessment will be done after one and half months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 researchers here describe the evaluation of pain & surgical outcomes in the Manual Small Incision Cataract Surgery between the topical versus SubTenon’s anaesthesia. The current study will be conducted for 2 years in the tertiary rural care hospital, Wardha, which is a 2-arm parallel interventional study which will included 56 patients in total (Group topical and Group Sub-Tenon’s anaesthesia). Before the patients undergo the intervention trail the demographic details, will be collected on the proforma & after the surgery the later data (VAS score and the Post surgery counselling checklist- Cataract surgery) will be collected on the EXCEL sheet & required statistical analysis will be done. A significant findings between the pain & surgical outcomes between the topical v/s Sub tenon’s anaesthesia in the MSICS is expected. |