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CTRI Number  CTRI/2019/06/019697 [Registered on: 17/06/2019] Trial Registered Prospectively
Last Modified On: 12/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to assess the outcome of two different corneal rings combined with corneal tissue strengthening treatment in patients with cone-shaped cornea 
Scientific Title of Study   A Clinical Study to evaluate the Outcome after implantation of two different commercially available Intra Stromal Rings combined with Collagen cross linking in patients with Keratoconus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prateek Teotia 
Designation  Senior Consultant 
Affiliation  Centre for sight 
Address  Room No. 301 Department of Cornea, Cataract and Refractive sevices Centre for sight B-5/24 Safdarjung Enclave New Delhi - 110029
Centre for sight B-5/24 Safdarjung Enclave New Delhi - 110029
South West
DELHI
110029
India 
Phone  8750014567  
Fax    
Email  prateekteotia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prateek Teotia 
Designation  Senior Consultant 
Affiliation  Centre for sight 
Address  Room No. 301 Department of Cornea, Cataract and Refractive services Centre for sight B-5/24 Safdarjung Enclave New Delhi - 110029
Centre for sight B-5/24 Safdarjung Enclave New Delhi - 110029
South West
DELHI
110029
India 
Phone  8750014567  
Fax    
Email  prateekteotia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mithun Thulasidas 
Designation  Senior Resident 
Affiliation  Centre for sight 
Address  Fellow Room No. 301 Department of Cornea, Cataract and Refractive services Centre for sight B-5/24 Safdarjung Enclave New Delhi - 110029
Centre for sight B-5/24 Safdarjung Enclave New Delhi - 110029
South West
DELHI
110075
India 
Phone  7406298745  
Fax    
Email  mithun.thulasidas@gmail.com  
 
Source of Monetary or Material Support  
Biotech Vision Care Pvt. Ltd. Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India 
 
Primary Sponsor  
Name  Biotech Vision Care Pvt Ltd 
Address  Biotech Vision Care Pvt. Ltd. Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow BRTS Stop Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India 
Type of Sponsor  Other [Ophthalmology Products Manufacturer] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mithun Thulasidas  Centre for Sight  Room No. 301 Department of Cornea, Cataract and Refractive services Centre for sight B-5/24 Safdarjung Enclave New Delhi - 110029
South West
DELHI 		 7406298745

mithun.thulasidas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre For Sight Institutional Medical Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H186||Keratoconus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BIORING  1.Material Medical Grade Poly Methyl Methacrylate CQ UV 2.Models BR5 (5mm optical zone) 3.Thickness BR5: 150μm to 350μm (in 50μm increments) 4.Arc BR5: 90º, 120º, 160º, 210º and 320º 
Comparator Agent  FERRARA RING  1.Material Polymethyl Methacrylate (PMMA) with natural filter for blue light. 2.Models AFR (optical area of 5 mm) 3.Thickness 0.15, 0.20, 0.25, 0.30, 0.35 mm 4.Arc 90°, 120°, 140°, 150°, 160°, 180°, 210°, 320° 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Unilateral/bilateral
2. A diagnosis of keratoconus, intolerance for contact lenses or glasses.
3. Progressing keratoconus. (Decrease in visual acuity of at least 1 line excluding non-corneal causes of deterioration/ steepening of at least 1D in steepest keratometry over last 6 months/ more than 1 in prescription of change of glasses or contact lens over the last 2 years)
4. Patients with Keratometric readings ≥ 48 D
5. Patients ≥ 18 years of age
6. Patients with clear cornea
7. Patients with corneal thickness ≥ 450 microns at the proposed incision site.
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. Patients with maximum keratometry (K) values greater than 65.00 diopters (D),
2. Patients with keratometric readings < 48 D
3. Apical opacity and scarring.
4. Hydrops.
5. Previous corneal or Intraocular surgery
6. Corneal thickness less than 450 microns at the planned site of Intrastromal rings implantation (5.0 mm optical zone).
7. Pregnancy & Lactation
8. Concurrent participation in another drug or device Study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Uncorrected Visual acuity
Best Corrected Visual acuity 		 Pre-operative visit, 3, 6, and 12 Months Follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
Refraction
Change in Topography patterns
Reduction in Spherical Equivalence refractive error
Corneal Thickness
Change in Keratometric values
Endothelial cell count
Adverse Event/complication after implanting BIO RING
 		 Pre-operative visit, 3, 6, and 12 Months Follow-up
Adverse event: At Intra-Op, 1 Day, 7 Day, 1, 3, 6 and 12 Months Follow-up 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   01/07/2019 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This is an Investigator Initiated prospective, comparative Clinical Study to evaluate and compare the Outcome of two different Intra Stromal Rings implantation along with corneal collagen cross-linking technique in patients with Keratoconus using a Femtosecond laser-assisted procedure. The objective of this study is to evaluate and compare the clinical outcomes of two different Intra Stromal Rings implanted in patients with Keratoconus a Femtosecond laser-assisted procedure in terms of Visual Acuity, Spherical Equivalent Diopter, Keratometry, corneal thickness, topographic pattern, Endothelial cell count & Corneal Astigmatism. The rationale of conducting this study is to demonstrate the clinical outcomes of ICRS in progressive Keratoconus at 3, 6 & 12 months following the procedure, using corneal topography. Since it is a newer, less invasive and less time consuming treatment modality it will help us treat the patients of Keratoconus more effectively who otherwise had little treatment options available. This study will follow ICH standards for clinical research including ICH –E6 (GCP) and ICH E3 (Study Reporting); ISO 14155 standards for Conduct of the study.
 
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