| CTRI Number |
CTRI/2024/10/075083 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observation of vision result and problems in microscopic cataract surgery |
|
Scientific Title of Study
|
A observational study of visual outcome and complications of phacoemulsification surgery in Various types of senile cataract at tertiary eye care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramswaroop Harsolia |
| Designation |
Professor |
| Affiliation |
JLN Medical College and Hospital ajmer |
| Address |
Dept of ophthalmology
JLN Medical College and Hospital ajmer
Rajasthan 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414669886 |
| Fax |
|
| Email |
drrsheye@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manvi kawat |
| Designation |
PG Student |
| Affiliation |
JLN Medical College and Hospital ajmer |
| Address |
Dept of ophthalmology
JLN Medical College and Hospital ajmer
Rajasthan 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
7727803225 |
| Fax |
|
| Email |
manvi.kawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramswaroop Harsolia |
| Designation |
Professor |
| Affiliation |
JLN Medical College and Hospital ajmer |
| Address |
Dept of ophthalmology
JLN Medical College and Hospital ajmer
Rajasthan 305001
RAJASTHAN
305001
India |
| Phone |
9414669886 |
| Fax |
|
| Email |
drrsheye@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN Medical college and hospital Ajmer Rajasthan 305001 India |
|
|
Primary Sponsor
|
| Name |
JLN Medical college and hospital Ajmer |
| Address |
JLN Medical college and hospital Ajmer Rajasthan 305001 |
| 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 Ramswaroop harsolia |
JLN Medical college and hospitals |
Room No 04
Department of Ophthalmology
Ajmer
RAJASTHAN |
9414669886
drrsheye@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee JLN Medical college and hospital Ajmer |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Both males & female patients having senile cataract are subjected to
phacoemulsification
2 Age 45 years or above |
|
| ExclusionCriteria |
| Details |
1 Patients below 45 years of age
2 Not willing to give consent for this study
3 Having pre pre-existing corneal disease
4 Having a history of any type of glaucoma
5 Having any retinal diseases
6 Patients affected by Fuchs dystrophy
7 Patients diagnosed with uveitis
8 Patients who are suffering from pseudoexfoliation zonular dehiscenc and subluxated lens
9 Patient who has a history of traumatic events
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual outcome in different types of senile cataracts |
day 0
day 3
day 7
day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
complications during and after
phacoemulsification surgery |
day 0
day 3
day 7
day 30 |
|
|
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)
|
15/10/2024 |
| 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="0"
Months="3"
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 goal of this study is to know the complications during and after
phacoemulsification surgery and visual outcome in different types of senile cataracts at a tertiary care centre |