| CTRI Number |
CTRI/2024/06/069209 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy between dwek that is removal of descemet layer of cornea and dwek with topical ripasudil in patients suffering from Fuchs endothelial corneal dystrophy . |
|
Scientific Title of Study
|
Comparison of efficacy between descemetorhexis without endothelial keratoplasty (DWEK) with or without topical rho kinase inhibitor in Fuch’s endothelial corneal dystrophy (FECD). |
| 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 Parul Jain |
| Designation |
Associate Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department Of Ophthalmology, Maulana Azad Medical College,Guru Nanak Eye Centre, New Delhi,
DELHI
110002
India
Central
DELHI
110002
India |
| Phone |
01123234622 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avinash Pradhan |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department Of Ophthalmology, Maulana Azad Medical College,Guru Nanak Eye Centre, New Delhi,
DELHI
110002
Central
DELHI
110002
India |
| Phone |
01123234622 |
| Fax |
|
| Email |
hnapradhan18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash Pradhan |
| Designation |
Post Graduate Resident |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department Of Ophthalmology, Maulana Azad Medical College,Guru Nanak Eye Centre, New Delhi,
DELHI
110002
Central
DELHI
110002
India |
| Phone |
01123234622 |
| Fax |
|
| Email |
hnapradhan18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology ,MAMC , Guru Nanak Eye Centre ,New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
MAULANA AZAD MEDICAL COLLEGE DELHI GATE NEW DELHI 110002 |
| 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 Avinash Pradhan |
Guru Nanak Eye Center |
Room number 207 , second floor ,Cornea services, Department of Ophthalmology ,MAMC , Guru Nanak Eye Centre ,New Delhi-110002
Central
DELHI |
9971979848
hnapradhan18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Maulana Azad medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H185||Hereditary corneal dystrophies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DWEK (Descemetorhexis without endothelial keratoplasty ) |
Patients will undergo phacoemulsification followed by intraocular lens placement . The anterior chamber will be filled with viscoelastic material . Descemet membrane of around 4 mm diameter will be gently torn in a circular fashion. |
| Comparator Agent |
DWEK( Descemetorhexis without endothelial keratoplasty ) |
Patients will undergo phacoemulsification followed by intraocular lens placement . The anterior chamber will be filled with viscoelastic material . Descemet membrane of around 4 mm diameter will be gently torn in a circular fashion. Then patients will be started on topical ripasudil 0.4 percent, four times a day for 2 months . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults with Fuchs dystrophy diagnosed clinically with cataract .
Dense central guttae limited to central 5mm of cornea .
Central stromal edema with visually significant complaints, morning blur .
Clear peripheral cornea with an endothelial cell count of more than 1000 cells / mm square . |
|
| ExclusionCriteria |
| Details |
Advanced corneal edema defined as the presence of bullae or scarring .
Presence of secondary corneal pathology such as infective or autoimmune keratitis .
All patients with any retinal pathology ,advanced glaucoma corneal edema other than FECD.
Patients on hormonal therapy /Oral contraceptive pills. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in central corneal thickness |
Preop ,post op day 1 ,at 1 month ,then monthly till 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in endothelial cell count in central and periphery . |
6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 1 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 Applicable |
| 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 is a randomized, single blinded , clinical trial comparing the efficacy between descemetorhexis without endothelial keratoplasty (DWEK) with or without topical rho kinase inhibitor in fuch’s endothelial corneal dystrophy (FECD) that will be conducted in Guru nanak eye centre comprising 12 per group of sample. Primary outcome is change in Central corneal thickness at 6 months and secondary outcome is change in endothelial cell count at central cornea and periphery at 6 months . |