| CTRI Number |
CTRI/2023/06/054433 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different endothelial keratoplasties named PDEK (pre-descemets endothelial keratoplasty) and DMEK ( Descemets endothelial keratoplasty) in terms of surgical outcomes. |
|
Scientific Title of Study
|
An interventional study to evaluate surgical outcomes after descemets membrane endothelial keratoplasty(DMEK) and pre-descemets endothelial keratoplasty(PDEK) for corneal endotheliopathies |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharamveer S Choudhary |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College ,Jaipur |
| Address |
Department of ophthalmology,sms medical college,JLN Road jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
09252032662 |
| Fax |
|
| Email |
drdschoudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dharamveer S Choudhary |
| Designation |
Associate Professor |
| Affiliation |
SMS Medical College ,Jaipur |
| Address |
Department of ophthalmology,sms medical college,JLN Road jaipur,Rajasthan
RAJASTHAN
302004
India |
| Phone |
09252032662 |
| Fax |
|
| Email |
drdschoudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeba shaheen |
| Designation |
resident doctor |
| Affiliation |
SMS Medical College ,Jaipur |
| Address |
Department of ophthalmology,sms medical college,JLN Road jaipur,Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
7891626657 |
| Fax |
|
| Email |
drzebashaheen014@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of ophthalmology,S.M.S Medical college,Jaipur |
|
|
Primary Sponsor
|
| Name |
department of OPhthalmology |
| Address |
department of ophthalmology,S.M.S. Medical college,JLN Road Jaipur |
| 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 |
| Dharamveer S Choudhary |
S.M.S. medical college,jaipur |
Department of ophthalmology,S.M.S. Medical college, JLN Road,jaipur
Jaipur
RAJASTHAN |
9252032662
drdschoudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Comittee S.M.S. Medical college and Attached Hospitals,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
descemets membrane endothelial keratoplasty surgery |
a group of patient with endotheliopathies are operated with descemets membrane endothelial keratoplasty surgery and follow up for 3 months for different parameters like visual acuity,endothelial count,central corneal thickness |
| Comparator Agent |
pre-descemets membrane endothelial keratoplasty surgery |
another group of patients with endotheliopathies are operated with pre-descemets membrane keratoplasty and follow up for 3 months for different parameters visual acuity,endothelial count,central corneal thickness and data compared with the patient operated by descemets membrane endothelial keratoplasty surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
•Patients who will give written informed consent.
•All patients of PBK, Corneal Decompensation, Endotheliopathies without any active infection
|
|
| ExclusionCriteria |
| Details |
. Patients with Corneal Scar
. Patient with anterior chamber IOL (ACIOL)
. Patient with iris Scars and large Atrophic Patches
.Patient with Glaucoma Shunt Surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
visual acuity
endothelial count
central corneal thickness
NCT |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
visual acuity
endothelial count
central corneal thickness
NCT |
3 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/06/2023 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response (Others) - can be shared as per law
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - DATA will be available with with authorities at SMS Medical college jaipur as per law
- For how long will this data be available start date provided 01-09-2025 and end date provided 31-08-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Until the last years of last century, Penetrating Keratoplasty (PK) was the
only way to surgically treat endothelial dysfunction. . Since then there has been a major change in medical management of these
pathologies.A technique of EK is Descemet Membrane Endothelial Keratoplasty (DMEK). It involves removal of Descemet’s membrane and
endothelium,but with replacement of only these two layers without posterior
stroma. It claims an even faster visual recovery and better visual outcome than
with DSAEK(Also a technique of EK) Pre‑Descemet’s EK (PDEK) is a newer variant in the arena of EK , is a novel procedure and it
involves the separation of PDL along with DM‑endothelium as
a donor lenticule after performing descemetorrhexis. According
to proponents of the technique PDEK offers the ability to use corneal tissue
from younger donars.
The most significant advantage of PDEK is that it is not
dependent on the corneal donor age, whereas DMEK cannot be done unless the
donor is above 40 years of age, given the increased tendency for graft
scrolling. Additionally, a PDEK graft is advantageous in that it is only 25 µm
to 30 µm thick, minimizing graft-host interface postoperative haze. Notably,
even though the PDEK graft is thin, the pre-Descemet’s layer preservation
within the graft is the critical component that allows for ease of graft
movement within the eye, minimizing the risk of graft tearing. |