| CTRI Number |
CTRI/2024/04/066389 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study is undertook to see effects of conventionally used trypan blue dye over corneal endothelial cells by comparing between corneal endothelial cell densities after phacoemulsication performed with and without use of trypan blue dye.
|
|
Scientific Title of Study
|
Comparison of corneal endothelial cell Density,with and without use of Trypan blue dye for staining of anterior lens capsule after 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. Shreya Patel |
| Designation |
resident doctor |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Ophthalmology department , Sir T hospital , jail road Kalanala Bhavnagar, Gujarat.
Bhavnagar
GUJARAT
364001
India |
| Phone |
7972133263 |
| Fax |
|
| Email |
shrey8007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shreya Patel |
| Designation |
resident doctor |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Ophthalmology department , Sir T hospital , jail road Kalanala Bhavnagar, Gujarat.
Bhavnagar
GUJARAT
364001
India |
| Phone |
7972133263 |
| Fax |
|
| Email |
shrey8007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shreya Patel |
| Designation |
resident doctor |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE BHAVNAGAR |
| Address |
Ophthalmology department , Sir T hospital , jail road Kalanala Bhavnagar, Gujarat.
Bhavnagar
GUJARAT
364001
India |
| Phone |
7972133263 |
| Fax |
|
| Email |
shrey8007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and sir t hospital, bhavnagar, gujarat |
|
|
Primary Sponsor
|
| Name |
SIR T GENERAL HOSPITAL |
| Address |
Department Of ophthalmology, Sir T hospital, Bhavnagar, Gujarat |
| Type of Sponsor |
Government 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 Shreya N Patel |
Sir Takhtasinhji general hospital |
Department of Ophthalmology, Sir Takhtasinji General Hospital, Bhavnagar.
Bhavnagar
GUJARAT |
7972133263
shrey8007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, (2) ICD-10 Condition: H259||Unspecified age-related cataract, (3) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
trypan blue dye |
capsulotomy performed with and without use trypan blue dye for staining of anterior lens capsule |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) patients of immature senile cataract grade 1,2,3(by LOCS classification) with good retropupillary glow
2) uncomplicated cataract |
|
| ExclusionCriteria |
| Details |
1.tear film abnormalities
2.any corneal pathology
3.pupillary disorders
4.traumatic cataract
5.mature cataract
6.grade 4 cataract
7.vitreous and retinal pathology
8.history of ocular surgery in study eye
9.known case of diabetes mellitus
10.uncontrolled hypertension
11.uncooperative patients |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare corneal endothelial cell density between patients with and without use of trypan blue dye for staining of anterior lens capsule during phacoemulsification. |
at the end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare central corneal thickness between patients with & without use of trypan blue dye for staining of anterior lens capsule during phacoemulsification. |
at the end of 12 months |
| To compare central corneal thickness between patients with & without use of trypan blue dye for staining of anterior lens capsule during phacoemulsification |
at the end of 12 months |
|
|
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)
|
10/05/2024 |
| 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="1"
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
|
trypan blue is a vital dye that is used in a concentration of 0.06% 1ml to stain the anterior lens capsule in cataract surgeries for better visualization during capsulotomy study is being undertaken to asses the effects of trypan blue over corneal endothelial cells by comparing corneal endothelial cell density and central corneal thickness between patients with and without use of trypan blue dye for staining of anterior lens capsule during phacoemulsification |