| CTRI Number |
CTRI/2025/02/080364 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Topical Ripasudil in patients with corneal edema post-cataract surgery |
|
Scientific Title of Study
|
Role of Ripasudil in faster resolution of corneal edema in patients post cataract surgery
|
| 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. Shubashree Karat |
| Designation |
Assistant professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of OPhthalmology,
Room No 20,
St Johns medical college and hospital,
Sarjapur main road
Kormangala
sarjapur main road,
Koramangla , Bangalore 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
9900325184 |
| Fax |
|
| Email |
shubashree.karat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubashree Karat |
| Designation |
Assistant professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of OPhthalmology,
Room No 20,
St Johns medical college and hospital,
Sarjapur main road
Kormangala
sarjapur main road,
Koramangla , Bangalore 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
09900325184 |
| Fax |
|
| Email |
shubashree.karat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubashree Karat |
| Designation |
Assistant professor |
| Affiliation |
St Johns Medical College and Hospital |
| Address |
Department of OPhthalmology,
Room No 20,
St Johns medical college and hospital,
Sarjapur main road
Kormangala
sarjapur main road,
Koramangla , Bangalore 560034
Bangalore
KARNATAKA
560034
India |
| Phone |
09900325184 |
| Fax |
|
| Email |
shubashree.karat@gmail.com |
|
|
Source of Monetary or Material Support
|
| St Johns medical college and hospital,
Sarjapur main Road
Koramangala
Bangalore- 560034 |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College |
| Address |
Sarjapur main road
Koramangla, Bangalore 560034 |
| 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 Shubashree |
st johns medical college hospital |
Department of Ophthalmology,
Room No 20,
St Johns medical college and hospital,
Sarjapur main road
Koramangla, Bangalore 560034
Bangalore
KARNATAKA |
9900325184
shubashree.karat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St. Johns Medical College Hospital, Bangalore 560034, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H181||Bullous keratopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
hypertonic saline 5% |
instilled twice a day for 2 weeks.
|
| Intervention |
ripasudil eyedrops 0.4% |
Ripasudil eyedrops will be instilled twice a day for 2weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing cataract surgery- Phacoemulsification and small incision cataract surgery with any grade of corneal edema on post-operative Day 1 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the potential of Ripasudil 0.4% in resolution of corneal edema postoperatively, to obtain corneal transparency. |
every subject is followed up at the end of 1st week, 2nd week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of ripasudil versus standard of care in treatment of postoperative corneal edema |
all participants of the trial are followed up over 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Research indicates that ripasudil may improve the healing of corneal endothelial wounds in rabbit models(4), highlighting its potential for safeguarding the corneal endothelium during eye surgeries. Despite this, there is still no clear agreement on using ripasudil in human subjects to protect the cornea following intraocular surgeries. Recent findings (5) suggest that ripasudil could help maintain the functional integrity of the corneal endothelium and reduce cell loss after cataract surgery in patients with low endothelial cell density (ECD). These observations point to the possibility of employing ripasudil more broadly to protect the corneal endothelium after such procedures. The purpose of this study is to assess the effectiveness of ripasudil in preserving corneal ECD after standard cataract surgery.
|