| CTRI Number |
CTRI/2019/11/021841 [Registered on: 01/11/2019] Trial Registered Prospectively |
| Last Modified On: |
31/10/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A COMPARITIVE STUDY OF TWO DIFFERENT O.1 % VITAMIN B12 DYE FOR STRENGTHENING OF CORNEA IN THIN AND CONICAL CORNEAS |
|
Scientific Title of Study
|
A prospective clinical Study to evaluate the Safety and Efficacy of two different 0.1% Riboflavin used in Corneal Cross-linking treatment for patients with Keratoconus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RIBOFLAVIN-001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr sri ganesh |
| Designation |
chairman and md nethradhama superspeciality eye hospital |
| Affiliation |
nethradhama super speciality eye hospital |
| Address |
Phaco refractive department, 2nd floor, OPD block,# 256/14, Kanakapura Main Road,
7th Block, Jayanagar,
Bangalore-560 082.
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr sri ganesh |
| Designation |
chairman and md nethradhama superspeciality eye hospital |
| Affiliation |
nethradhama super speciality eye hospital |
| Address |
Phaco refractive department, 2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar,
Bangalore-560 082.
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr sri ganesh |
| Designation |
chairman and md nethradhama superspeciality eye hospital |
| Affiliation |
nethradhama super speciality eye hospital |
| Address |
Phaco refractive department, 2nd floor, OPD block, # 256/14, Kanakapura Main Road,
7th Block, Jayanagar,
Bangalore-560 082.
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
|
Source of Monetary or Material Support
|
| BIOTECH OPHTHALMICS PVT. LTD
Block 1, Abhishree Corporate Park,
Opp. Swagat Bunglow BRTS Stop
Bopal - Ambli Road,
Ahmedabad - 380 058,
Gujarat India.
|
|
|
Primary Sponsor
|
| Name |
BIOTECH HEALTHCARE PVT LTD |
| Address |
BLOCK 1, ABHISHREE CORPORATE PARK, OPPOSITE SWAGAT BUNGLOW, BRTS STOP, BOPAL- AMBLI ROAD, AHMEDHABAD 380 058, GUJARAT , INDIA |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr sri ganesh |
nethradhama super speciality eye hospital |
# 256/14, Kanakapura Main Road,
7th Block, Jayanagar,
Bangalore-560 082.
Bangalore
KARNATAKA |
9845129740
phacomaverick@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee for research on humen subjects |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
keratoconus, (1) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.1% Riboflavin (Flavin solution) |
0.1% Flavin dye will be used for conventional cross linking and the safety and efficacy will be compared with the 0.1% riboflavin formulation from an established brand( Peschke) |
| Comparator Agent |
Pescke D [0.1% riboflavin solution] |
Peschke® D Standard Riboflavin Solution with Dextran
(PESCHKE Trade GmbH, Switzerland)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Unilateral/bilateral
2. A diagnosis of keratoconus.
3. Progressing keratoconus.
4. Patients with Keratometric readings ≤ 55 D
5. Patients ≥ 18 years of age
6. Patients with clear central cornea, without apical scarring.
7. Patients with corneal thickness ≥ 400 microns at the thinnest point.
8. Patient willing to participate and sign informed consent
9. Patient willing to come for all post-operative follow-up procedures as defined in study protocol.
|
|
| ExclusionCriteria |
| Details |
1. Eyes classified as either normal, atypical normal (except corneal ectasia), or keratoconus suspect on the severity grading scheme.
2. A history of previous corneal surgery or the insertion of intrastromal ring implantation in the eye(s) to be treated.
3. Previous corneal or Intraocular surgery
4. Pellucid marginal corneal degeneration
5. Eyes which are aphakic or pseudophakic and do not have a UV blocking lens implanted.
6. A history of delayed epithelial healing.
7. Patients with nystagmus or any other condition that would have prevented a steady gaze during the CXL treatment or other diagnostic tests.
8. Pregnancy & Lactation
9. Concurrent participation in another drug or device Study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
•Progression of Keratoconus [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]
•Best Corrected Visual acuity [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]
Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
•Endothelial Cell Count [Time Frame: Pre-operative visit, 1,3, 6 & 12 Months Follow-up]
As measured by Specular Microscope
|
Pre-operative visit, 1,3, 6 & 12 Months Follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Refraction
Corneal Demarcation Line Depth (DLD)
Corneal Haze
Uncorrected Visual acuity
Corneal Thickness Change in K1, K2 and Kmean Value
|
Pre-operative visit, 1,3, 6 & 12 Months Follow-up |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/11/2019 |
| 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
|
1.Wollensak G, Spoerl E, Seiler T.Riboflavin 0.1%/ultraviolet-a-induced collagen crosslinking for the treatment of Keratoconus. Am J Ophthalmol. 2003 May;135(5):620–7.
2.Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with Riboflavin 0.1% and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008;34(5):796-801.
3.Agrawal V. Long-term results of cornea collagen crosslinking with Riboflavin 0.1% for Keratoconus. Indian J Ophthalmol. 2013;61(8):433-4. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a prospective, comparative, open label, clinical study aimed to evaluate the safety and efficay of two different 0.1% Riboflavin solutions used in corneal cross-linking treatment for patients with keratoconus. Flavin Isotonic Riboflavin Ophthalmic Solution 0.1%- Flavin (Biotech Ophthalmics Pvt. Ltd., India) will be compared with Peschke® D Standard Riboflavin Solution (PESCHKE Trade GmbH, Switzerland). 100 Eyes of patients with unilateral or bilateral keratoconus will be randomized to receive treatment with either Flavin or Peschke isotonic riboflavin 0.1% solutions, with 50 eyes in each group. Post operative follow up will be conducted at 1,3, 6 & 12 Months and the clinical parameters evaluated between the two groups will be - uncorrected and best corrected visual acuity, refraction, change in keratometry and corneal thickness & endothelial cell count. Any adverse effects or post operative complications such as haze, corneal oedema, infection etc, will be immediately reported to ethics committee and necessary steps will be taken.
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