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CTRI Number  CTRI/2022/08/044694 [Registered on: 16/08/2022] Trial Registered Prospectively
Last Modified On: 01/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To determine Visual Improvement in patients with Conical Protrusion of Eye after inserting transparent ring into the Eye as a Treatment 
Scientific Title of Study   Visual Outcomes of Intra Corneal Ring Segments in the Management 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  Dr Husna K 
Designation  Junior Resident  
Affiliation  Sankara Eye Hospital 
Address  Sankara Eye Hospital, Sivanandhapuram, Sathy Road, Coimbatore Doctor Hostel Sankara Eye Hospital

Coimbatore
TAMIL NADU
641035
India 
Phone  8943265419  
Fax    
Email  husnakattumunda786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Siddharthan KS 
Designation  Senior consultant Cornea 
Affiliation  Sankara Eye Hospital 
Address  Sankara Eye Hospital, Sivanandhapuram, Sathy Road, Coimbatore

Coimbatore
TAMIL NADU
641035
India 
Phone  9442257665  
Fax    
Email  siddharthanks@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Husna K 
Designation  Junior Resident  
Affiliation  Sankara Eye Hospital 
Address  Sankara Eye Hospital, Sivanandhapuram, Sathy Road, Coimbatore

Coimbatore
TAMIL NADU
641035
India 
Phone  8943265419  
Fax    
Email  husnakattumunda786@gmail.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital, Coimbatore 
 
Primary Sponsor  
Name  Sankara Eye Hospital 
Address  Sankara Eye Hospital, Sivanandhapuram, Sathy Road, Coimbatore 
Type of Sponsor  Other [Self] 
 
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 
DrHusna K  Sankara Eye Hospital  Sankara Eye Hospital, Sivanandapuram, Sathy Road, Coimbatore - 641 035
Coimbatore
TAMIL NADU 		 8943265419

husnakattumunda786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sankara Eye Hospital, Coimbatore  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  Intra Corneal Ring Segment  The main mode of action of Intra Corneal Ring Segment (ICRS) is Arc-shortening’ effect, caused by increased lamellar volume of the implant which increases stress on central cornea and consequent flattening effect on central cornea in keratoconus. Main Effects of ICRS are flattens of the cornea, dislocation of the corneal apex towards the centre, decreases surface irregularity, gives biomechanical support and they redistribute the bio- mechanical stress and prevent further steepening of the cornea. This study is designed to evaluate the visual outcomes of Intra corneal ring segments in the management of keratoconus by analysing the improvement in UCDVA, BCDVA, Manifest refraction, corneal tomography and topography keratometry readings. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Keratoconic eyes with

· age more than 21 years of age

· clear central corneas

· intolerance to both contact lens and spectacle correction

· minimum corneal thickness of 450 micrometer at the site of

incision and 350 micro meter at the central cornea

· patient with progressive keratoconus 
 
ExclusionCriteria 
Details  Keratoconic eyes with

· corneal opacities or central corneal scarring

· corneal dystrophies

· previous intra ocular or corneal surgery

· patient with recurrent corneal erosion syndrome

· local active infections/history of herpes keratitis

· other eye diseases like glaucoma /retinal diseases/ cataract

· localized or systemic autoimmune /immunodefieciency

syndrome/severe atopic d/s

· Diabetes (advanced and uncontrolled).

· Advanced keratoconus (stage 3 and 4 Amsler–Krumeich).

· Average keratometric reading >70D

· Hydrops

· Patients with grade 1-3 post-LASIK ectasia

· Patients on with chances of changing refractions like on steroids therapy and pregnancy.

· patients on Amiodarone, Sumatriptan, Isotretinoin therapy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To anlyse the improvement in

· uncorrected visual acuity

· best corrected visual acuity

· Manifest refraction

· Corneal Tomography and topography to measure flat keratometry reading(K1), steep keratometry reading(K2), and Kmax

in Keratoconus patients after Intra corneal ring segments insertion 		 Preop - At baseline
Postop - 1month, 3month,6month

 
 
Secondary Outcome  
Outcome  TimePoints 
To analyse the improvement in

· uncorrected visual acuity

· best corrected visual acuity

· Manifest refraction

· Corneal Tomography and topography

in Keratoconus patients after Intra corneal ring segments insertion 		 post op - 1 month, 3 month, 6 month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   16/08/2022 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Keratoconus  is  a progressive ,ectatic disease of the cornea characterized by  localised progressive thinning and forward protrusion of the cornea in which cornea assumes a conical shape , resulting in mild to marked impairement of visual acuity due to irregular astigmatism, progressive myopia and central corneal scarring

Keratoconus correction has always been a challenge

Various surgical procedures other than ICRS implantation have been investigated for keratoconus  correction with a clear cornea and contact lens intolerance. However, these procedures did not gain popularity due to the disappointing results including lack of predictability and stability and long period of rehabilitation and possible post operative complications

Intra corneal ring segments have been proposed and approved by FDA as an additive surgical procedure for keratoconus correction

INTACS implantation is safe, reversible,and minimally invasive procedure and does not affect the central visual axis of the cornea

The main mode of action of ICRS is  Arc-shortening’ effect, caused by increased lamellar volume of the implant which increases stress on central cornea and consequent flattening effect on central cornea 17,18

Main Effects of ICRS are flattens of the cornea, dislocation of the corneal apex towards the centre, decreases surface irregularity, gives biomechanical support and they redistribute the bio- mechanical stress and prevent further steepening of the cornea

This study is designed to evaluate the visual outcomes of intra corneal ring segments in the managements of of keratoconus by reshaping the cornea and by deceasing surface irregularity


 
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