| CTRI Number |
CTRI/2023/07/055136 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [biosynthetic cornea] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of synthetic cornea for treatment of Keratoconus |
|
Scientific Title of Study
|
To study the Outcomes of Intrastromal keratoplasty with
Biosynthetic corneas Versus Biolenticules from donor corneas in cases of Keratoconus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vidit Bansal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Rajendra prasad centre for Ophthalmic Sciences, AIIMS, New Delhi, Department of ophthalmology room no 106
South
DELHI
110027
India |
| Phone |
9871605473 |
| Fax |
|
| Email |
vidit.bansal95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAMRATA SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
AIIMS, New Delhi |
| Address |
Rajendra Prasad Centre for Opthalmic sceinces , Department of Ophthalmology, AIIMS
South
DELHI
110029
India |
| Phone |
01126593144 |
| Fax |
|
| Email |
office.drnamratasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vidit Bansal |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Ophthalmology, Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS
South
DELHI
110027
India |
| Phone |
9871605473 |
| Fax |
|
| Email |
vidit.bansal95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Prasad Institute for Ophthalmic Sciences,AIIMS ,Delhi |
|
|
Primary Sponsor
|
| Name |
Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
AIIMS, NEW DELHI |
| 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 Vidit Bansal |
Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi |
Rajndra Prasad Centre for ophthamlic Sciences, Department of Ophthalmology, room 102, AIIMS, DELHI
South
DELHI |
9871605473
vidit.bansal95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutute 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 |
| Comparator Agent |
intrsastromal lamellar keratoplasty using Biolenticule from Human Donor Cornea |
lamllar keratoplasty using femtosecond laser with human donor lenticule |
| Intervention |
intrsastromal lamellar keratoplasty using Bioynthetic cornea |
Intrasromal lamellar keratoplasty using femtosecond laser and biosynthetic cornea made from crosslinked collagen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Keratoconus
Age more than 18 years
Contact lens intolerant
Thinnest Pachymetry > 250 microns
Patients giving informed consent for surgery and willing for follow up |
|
| ExclusionCriteria |
| Details |
Healed hydrops
Diabetes, connective tissue disease or atopy
Pregnant or lactating patients
Patient not willing to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| tectonic support to cornea, change in astigmatism |
changes seen at Post operative day 1, day 7, at 4 weeks and 3month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in lower order aberrations and higher order aberrations of cornea |
changes seen at Post operative day 1, day 7, at 4 weeks and 3month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/08/2023 |
| 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="1"
Months="6"
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
|
Written informed consent will be taken from the patient. A detailed history and clinical examination will be done according to the above-mentioned parameters which will include visual acuity testing of both uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) measured using Snellen’s Chart. A detailed slit lamp examination will be done by an expert cornea specialist, a dilated fundoscopy to rule out any coexistent ocular disorders, non-contact Tonometry for Intra Ocular Pressure measurement and Central Corneal Thickness will also be done. High-Definition Anterior segment OCT, optical biomechanics and corneal wavefront aberrometry will be performed. A single surgeon, Prof. Namrata Sharma, will be performing all the surgeries under topical anesthesia. Under topical anesthesia, a corneal intrastromal pocket will be created using Femtosecond LASER system which will be extended by 0.75 to 1.0mm more than the base of cone of keratoconus cornea. Under microscope visualization intrastromal pocket will be opened using blunt lamellar dissection. Next, the biosynthetic cornea will be trephined using handheld trephine to 0.5mm oversize the base of the cone and will be placed in the intrastromal pocket. Entry wound will then be sealed with the help of fibrin glue. The patient will be evaluated at day 1, 1 week, 1 month and 3 months for visual acuity (uncorrected distance visual acuity, corrected distance visual acuity), Intraocular pressure by Non-contact Tonometry, Slit lamp bio microscopic examination, Fundus examination, High-Definition Anterior Segment Optical Coherence Tomography, corneal biomechanics and Tomography. |