| CTRI Number |
CTRI/2025/08/092435 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Ripasudil eye drops on cornea in post- operative cataract patients. |
|
Scientific Title of Study
|
A comparative study of the effect of Ripasudil (Rho-kinase inhibitor) on Corneal Endothelial Cell Density (ECD) and Central Corneal Thickness (CCT) in post-operative cataract patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumedha |
| Designation |
PG traniee |
| Affiliation |
Hindu Rao Hospital |
| Address |
Ophthalmology Department,
Hindu Rao Hospital,
Malkaganj
North
DELHI
110007
India |
| Phone |
8100296019 |
| Fax |
|
| Email |
sumedharoy1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navin Neeraj |
| Designation |
CMO (SAG) |
| Affiliation |
Hindu Rao Hospital |
| Address |
Ophthalmology Department,
Hindu Rao Hospital
Malkaganj
North
DELHI
110007
India |
| Phone |
9810722991 |
| Fax |
|
| Email |
drneeraj.sdnh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navin Neeraj |
| Designation |
CMO (SAG) |
| Affiliation |
Hindu Rao Hospital |
| Address |
Ophthalmology Department,
Hindu Rao Hospital
Malkaganj
North
DELHI
110007
India |
| Phone |
9810722991 |
| Fax |
|
| Email |
drneeraj.sdnh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anand P Narnoliya |
| Address |
Medical superintendent,
Room no-107, 1st floor, G- block, Hindu Rao Hospital,
Sabji Mandi, Malkaganj, Delhi,India 110007 |
| 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 Sumedha |
Hindu Rao Hospital |
Room no. 311, Eye OPD,Ophthalmology Department,OPD BLOCK, Hindu Rao Hospital, Sabji Mandi, Malkaganj,Delhi 110007
North
DELHI |
8100296019
Sumedharoy1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, North DMC Medical College and Hindu Rao Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H590||Disorders of the eye following cataract surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Comparator Agent |
No extra drug/ sham |
Standard regimen of post-operative cataract care |
| Intervention |
Ripasudil eye drops |
Ripasudil eye drops (0.4% w/v) along with standard post-operative cataract care for all patients |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Senile uncomplicated cataract of up to NS grade III
2.No previous history of intraocular surgery
3.Pre-operative endothelial cell count at least greater than 1500 cells/mm2
|
|
| ExclusionCriteria |
| Details |
1.History of previous ocular trauma, surgery, intra-ocular inflammation
2.Diagnosed case of glaucoma
3.Corneal opacity
4.Traumatic cataract
5.Ocular surface disorders (eg. Pterygium)
6.Adenexal diseases (eg. Ectropion, trichiasis)
7.Contact lens wear
8.Pseudo-exfoliation
9.Diabetes
10.Complicated cataract surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| corneal endothelial cell density (ECD) and central corneal thickness (CCT) |
Pre-operatively
Post-operative 1 week
Post-operative 1 month
Post-operative 3 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of hexagonal cells (HEX) |
Pre-operatively
Post-operative 1 Week
Post-operative 1 month
Post-operative 3 month
|
| Coefficient of variation (CV) |
Pre-operatively
Post-operative 1 week
Post-operative 1 month
Post-operative 3 month |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
16/08/2025 |
| 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="0"
Months="9"
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
|
This study will be done on 78 patients attending ophthalmology OPD in Hindu Rao Hospital, for cataract surgery. The patients will be divided into 2 groups- group A - where Ripasudil eye drop was given post-operatively with standard post operative care for cataract surgery and group -B- where Ripasudil eye drop was not given post-operatively though standard post operative care for cataract surgery was given. All patients will undergo pre-operative and post-operative specular microscopy for endothelial cell density, CCT, HEX and CV {using Topcon Specular Microscope(SP-1P model)} along with complete eye examination. All patients will be examined post-operatively at 1 week, 1 month and 3 month. in follow-up visits, patient will undergo BCVA assessment, NCT, slit-lamp examination, specular microscopy and fundoscopy, which will be documented in preset proforma.
|