| CTRI Number |
CTRI/2022/12/048296 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
19/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Intrastromal Lamellar Keratoplasty with C3R in Keratoconus |
|
Scientific Title of Study
|
Evaluation of Intrastromal Lamellar Keratoplasty with Collagen Cross-linking in Keratoconus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SWATHI M S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS NEW DELHI |
| Address |
DR RP CENTRE, AIIMS NEW DELHI, Sri Aurobindo Marg
Ansari Nagar
Ansari Nagar East
New Delhi
Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8494942610 |
| Fax |
|
| Email |
msswathi.blr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF M VANATHI |
| Designation |
PROFESSOR |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS NEW DELHI |
| Address |
ROOM NO 475, 4TH FLOOR, Dr RP CENTRE, Sri Aurobindo Marg
Ansari Nagar
Ansari Nagar East
New Delhi
Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9891344325 |
| Fax |
|
| Email |
mvanathi.rpc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SWATHI M S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS NEW DELHI |
| Address |
Dr RP CENTRE, Sri Aurobindo Marg
Ansari Nagar
Ansari Nagar East
New Delhi
Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8494942610 |
| Fax |
|
| Email |
msswathi.blr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
AIIMS Campus Temple, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SWATHI M S |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
ROOM 475, 4TH FLOOR,Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS Campus , Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
8494942610
msswathi.blr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of with keratoconus (thinnest pachymetry 350 – 400 microns) who are either not suitable for using contact lenses wear, intolerant to contact lens wear, willing to participate in the study and best corrected Snellen’s visual acuity (BCSVA)< 6/18 with spectacles will be included in the study. |
|
| ExclusionCriteria |
| Details |
1.Age < 18 years
2.BCSVA > 6/18 with spectacle correction
3.Axial myopia > 25.0 mm
4.Not willing to participate in the study
5.Patients with history of hydrops
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of this study will be to evaluate the role of intrastromal lamellar keratoplasty along with collagen cross-linking with riboflavin in keratoconus.
|
Follow up at day 1, month 1,3,6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of corneal biomechanics and improvement in visual acuity |
Follow up at day 1, month 1,3,6 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
25/12/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary objective of this study will be to evaluate the role of intrastromal lamellar keratoplasty along with collagen cross-linking with riboflavin in keratoconus. We aim to study the biomechanical changes in cornea following intrastromal lamellar keratoplasty with collagen cross linking in keratoconus |