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CTRI Number  CTRI/2025/01/079133 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To study a minimally invasive surgical treatment for Keratoconus and its impact on improvement of vision 
Scientific Title of Study   Visual and Topographic Outcomes of Corneal Allogenic Ring Segments in Keratoconus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
New ID  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivohn Annalie da Silva 
Designation  Postgraduate student 
Affiliation  Sankara Eye Hospital, Coimbatore 
Address  Department of Cornea and Refractive services, OPD No 30/31 Ground floor Sankara Eye Hospital, Coimbatore Sathy Road, Sivanandhapuram, Coimbatore, Tamil Nadu.

Coimbatore
TAMIL NADU
641035
India 
Phone  9763434340  
Fax    
Email  shivohndasilva@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagdeesh Kumar Reddy 
Designation  Consultant  
Affiliation  Sankara Eye Hospital, Coimbatore 
Address  Department of Cornea and Refractive services, OPD No 31, Ground floor Sankara Eye Hospital, Coimbatore Sathy Road, Sivanandhapuram, Coimbatore, Tamil Nadu.

Coimbatore
TAMIL NADU
641035
India 
Phone  9443047456  
Fax    
Email  jkreddy@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivohn Annalie da Silva 
Designation  Postgraduate student 
Affiliation  Sankara Eye Hospital, Coimbatore 
Address  Department of Cornea and Refractive services, OPD No 30/31 Ground floor Sankara Eye Hospital, Coimbatore Sathy Road, Sivanandhapuram, Coimbatore, Tamil Nadu.

Coimbatore
TAMIL NADU
641035
India 
Phone  9763434340  
Fax    
Email  shivohndasilva@gmail.com  
 
Source of Monetary or Material Support  
Sankara Eye Hospital, Coimbatore Sathy Road, Sivanandhapuram, Coimbatore, Tamil Nadu, India. 641035 
 
Primary Sponsor  
Name  Dr Shivohn Annalie da Silva 
Address  Sankara Eye Hospital, Coimbatore Sathy road, Sivanandhapuram, Coimbatore, Tamil Nadu 641035 
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 
Dr Shivohn Annalie da Silva  Sankara Eye Hospital  Department of Cornea and Refractive Services, OPD no 30/31,Ground floor.
Coimbatore
TAMIL NADU 		 9763434340

shivohndasilva@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Corneal Allogenic Intrastromal Ring Segments (CAIRS) and Collagen Cross linking (C3R)  Corneal Allogenic Intrastromal Ring Segments are small curvilinear segments which are trephined from donor corneal buttons and are placed deep in the corneal stroma to alter the corneal curvature and regularise the corneal surface. CAIRS PREPARATION: •Grade B/C donor corneal rim negative for HIV, HbsAg and HCV is taken. The donor cornea is placed endothelial side up, stained with Tryphan blue and then descement membrane is removed. Following this, epithelium is removed completely with Weckgel sponge. •The center of the tissue is marked with marker, trephine sizes are customized for every patient. The inner trephination (5mm, 5.5mm, 6mm) is done followed by outer trephination (8mm, 8.25mm, 8.5mm) •After full thickness double trephination, the tissue is hand trimmed to about 2/3rd of original thickness CAIRS IMPLANTATION: •The Intralase FS 60 femtosecond platform is used to create a femtosecond dissected circular channel. •The parameters used were inner diameter ranging from of 5.3- 6mm and outer diameter of 8.5- 8.8 mm at 50% depth of the minimum pachymetry in the 7 mm optical zone. •Two entry incisions are created based on the area of accessibility and ease of insertibility. CAIRS IMPLANTATION: •The Intralase FS 60 femtosecond platform is used to create a femtosecond dissected circular channel. •The parameters used were inner diameter ranging from of 5.3- 6mm and outer diameter of 8.5- 8.8 mm at 50% depth of the minimum pachymetry in the 7 mm optical zone. •Two entry incisions are created based on the area of accessibility and ease of insertibility. COLLAGEN CROSS LINKING: •Corneal epithelium is scrapped and 0.1 % Riboflavin is instilled, one drop every 30 seconds for a period of 6 minutes which is followed by accelerated cross linking (Averdo Machine) •A bandage contact lens is placed.   •Post operatively the patient is started on topical moxifloxacin eye drops 6 times a day for one week. •Patient is reviewed at 1 week, when bandage contact lens is removed, and then started on low dose topical steroids, lubricants and cyclosporine for 20 days. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Grade 1 to 4 Keratoconus patients (Amsler Krumeich grading) showing progression with sufficient minimum pachymetry 
 
ExclusionCriteria 
Details  Autoimmune and immunodeficiency syndromes
Previous viral keratitis
Thin cornea less than 350 micrometers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in UCVA by range of ≥ 2 lines
Improvement in BCVA by ≥ 1 line
Decrease in spherical and astigmatic error
Decrease in keratometry  		 Follow up at 1 week, 1 month, 3 months, 6 months and 1 year. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of inflammatory keratitis
Over correction or Under Correction of Refractive error
Adverse events – Infection increased stromal haze ( when combined with Collagen cross linking)  		 Follow up at 1 week, 1 month, 3 months, 6 months and 1 year. 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
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   Phase 4 
Date of First Enrollment (India)   01/02/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
My Postgraduate Thesis is on Visual and Topographic Outcomes of corneal allogenic intrastromal ring segments in Keratoconus.
Keratoconus is a slowly progressive, non inflammatory ectatic corneal disease characterized by changes in corneal collagen structure and organization. Prevalence of keratoconus (KC) is estimated at 2300/100,000 in Central India (0.0003–2.3%) highlighting the fact that keratoconus is much more prevalent than what is assumed. 
Corneal collagen cross‐linking is effective in stabilizing the progression of the disease but does not have a major impact on the improvement of visual acuity. Common methods of vision correction for keratoconus range from spectacles and rigid gas‐permeable contact lenses to other specialized lenses such as piggyback, Rose‐K, or Boston scleral lenses. 
Intrastromal corneal ring segments (ICRS) are small curvilinear segments which are made of PMMA, synthetic material that are placed deep in the corneal stroma to alter the corneal curvature and regularization of the corneal surface. However, being made of synthetic material, upto 30% rate of complications ranging from innocuous to sight threatening are reported. 
Corneal Allogenic Intrastromal Ring Segments is a new technique that utilizes a principle similar to synthetic segments but with the use of allogenic segments created from donor corneal buttons. This technique aims at decreasing the complications associated with the use of synthetic material within the patient’s corneal stroma and improving the visual outcomes.
 
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