| CTRI Number |
CTRI/2024/06/069094 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare different techniques of nucleotomy in topical phacoemulsification surgery |
|
Scientific Title of Study
|
A comparative study of divide and conquer, stop and chop and direct chop techniques of nucleotomy in topical 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 |
Devwrath Upasani |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department Of Ophthalmology, Acharya Vinobha Bhave Rural Hospital, Jawaharlal Nehru Medical College, Sawangi(Meghe), Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9699249064 |
| Fax |
|
| Email |
devuupasani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pravin Tidake |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Ophthalmology department, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7887476011 |
| Fax |
|
| Email |
drpktidake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devwrath Upasani |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Ophthalmology department, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9699249064 |
| Fax |
|
| Email |
devuupasani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of ophthalmology,JNMC, Sawangi , Wardha |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Sawangi Meghe, Wardha |
| 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 Devwrath Upasani |
Datta Meghe Institute Of Higher Education And Research |
Department Of Ophthalmology, Acharya Vinobha Bhave Rural Hospital, Sawangi(Meghe),Wardha Maharashtra
Wardha
MAHARASHTRA |
9699249064
devuupasani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Central corneal thickness by corneal topography, corneal endothelial cell loss by corneal topography, Visual acuity by snellens chart |
Visual acuity will be measured pre and post operatively and the surgical technique by which best visual acuity is attained post operatively will be the ideal surgery
Corneal endothelial cell count and central corneal thickness will be measured pre and post operatively using specular microscopy |
| Intervention |
Topical phacoemulsification |
3 techniques of nucleotomy will be performed by topical phacoemulsification namely direct chop, stop and chop, divide and conquer
The patients will have a follow up of 4 weeks
The duration of this study is 2 years
At the end of the study we will be able to decide which surgery is best for the patient based on various variables |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients >50 years of age with grade 1-3 Immature Senile Cataract.
2) Patients giving consent |
|
| ExclusionCriteria |
| Details |
1) Hazy cornea
2) Pre operative endothelial cell count < 1000/mm2
3) Very shallow anterior chamber
4) Nuclear sclerosis Grading 4/5
5) Non dilating pupil
6) Subluxated or dislocated lens
7) Patients < 50 years of age
8) Traumatic cataract
9) Complicated cataract
10) Small pupil
11) Patients not giving consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to compare Visual acuity, corneal endothelial cell count, and central corneal thickness after different techniques of topical phacoemulsification |
The variables would be measured in each patient pre operatively then again after post op day 1 and finally after a follow up of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual acuity, Central corneal thickness, Corneal endothelial cell loss after different techniques of topical phacoemulsification |
The variables would be measured pre operatively then after post op day 1 & after follow up of 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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
|
Cataract is the most common cause of preventable blindness in India and all around the world. The only available definitive treatment for cataract extraction is cataract surgery. Phacoemulsification is the latest surgery for cataract surgery. Various phacoemulsification techniques are used to break the nucleus of a cataractous lens. In this study, we will study and compare 3 such techniques based on variables like central corneal thickness, corneal endothelial cell loss, visual acuity and thus we will be able to conclude which surgery is best for the patient. |