| CTRI Number |
CTRI/2020/06/026137 [Registered on: 25/06/2020] Trial Registered Prospectively |
| Last Modified On: |
20/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Implantation of donor corneal lenticule in patients with advanced keratoconus using femtosecond laser and collagen cross linking. |
|
Scientific Title of Study
|
Femtosecond Laser Assisted Corneal Intrastromal Lenticule Implantation with Collagen Crosslinking in Advanced Keratoconus - A pilot prospective interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasoon Pradeep |
| Designation |
Junior Resident |
| Affiliation |
Dr R P Center of Ophthalmic Sciences |
| Address |
Ophthalmology,
Dr R.P Center, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9645785084 |
| Fax |
|
| Email |
prasoonpradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sinha |
| Designation |
Professor |
| Affiliation |
Dr R P Center of Ophthalmic Sciences |
| Address |
Ophthalmology,
Dr R.P Center, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
01126546466 |
| Fax |
|
| Email |
sinharaj1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasoon Pradeep |
| Designation |
Junior Resident |
| Affiliation |
Dr R P Center of Ophthalmic Sciences |
| Address |
Ophthalmology,
Dr R.P Center, AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9645785084 |
| Fax |
|
| Email |
prasoonpradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr R P Center for Ophthalmic Sciences |
| Address |
AIIMS New Delhi |
| 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 |
| Prasoon Pradeep |
Dr R P Center of Ophthalmic Sciences |
Room 106, Unit 3, Dr RPCenter, AIIMS, Ansari Nagar East
South
DELHI |
9645785084
prasoonpradeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Corneal Collagen Crosslinking with Riboflavin |
Application of riboflavin drops on cornea and exposing to UV-A light. |
| Intervention |
Femtosecond Intrastromal Lenticule Implantation |
Insertion of a corneal lenticule obtained from patients undergoing Small Incision Lenticule Extraction(SMILE) into Patients cornea in a pocket created using Femtolaser. |
| Comparator Agent |
Not Applicable |
NA |
| Intervention |
Small Incision Lenticule Extraction(SMILE) |
To attain the lenticules |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above 18 Years of age
2.Patients with Keratoconus with corneal thickness between 350 -400 microns
3.Patients intolerant to Contact Lens use
4.Cone size<6mm
5.Patients willing to give consent for the procedure
|
|
| ExclusionCriteria |
| Details |
1.Patients unwilling to give consent
2.Patients with corneal scarring/healed hydrops.
3.Patients with active allergic disease.
4.Patients with co existing posterior segment pathology.
5.Patients with collagen vascular disease or immunocompromised status.
6.One eyed patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Uncorrected visual Acuity |
1week, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Best Corrected Visual Acuity |
1week, 3 months, 6 months |
| Change in Corneal Thickness and Topography |
1week, 3 months, 6 months |
| Change in Corneal biomechanical Rigidity |
1week, 3 months, 6 months |
| Fit and Tolerance to Contact Lens |
1week, 3 months, 6 months |
|
|
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)
|
20/08/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Keratoconus is a progressive disease of cornea where there is progressive thinning and ectasia which leads to change in visual acuity and irregular astigmatism. Treatment involves use of rigid gas permeable contact lenses. However, some are intolerant. In such patients, corneal collagen crosslinking is attempted, however, it is contraindicated in thin corneas. We are attempting to implant a sheet of cornea obtained from patients undergoing small incision lenticule extraction(SMILE) inside the patients cornea to increase its thickness, prior to insertion, we use excimer laser to change the shape of the lenticule from myopic to hyperopic by flattening the center. This is followed by collagen cross linking to halt the progression of the disease. |