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CTRI Number  CTRI/2019/05/019153 [Registered on: 15/05/2019] Trial Registered Prospectively
Last Modified On: 13/05/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of ultima smart toric intraocular lens with tecnis toric intraocular lens 
Scientific Title of Study   Comparative evaluation of clinical outcomes of two types of toric intraocular lenses, the Ultima smart toric and the tecnis toric 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namrata Sharma 
Designation  Professor Department of ophthalmology 
Affiliation   
Address  Room number 481 Fourth floor Dr. R.P Centre AIIMS

South
DELHI
110029
India 
Phone    
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Namrata Sharma 
Designation  Professor Department of ophthalmology 
Affiliation   
Address  Room number 481 Fourth floor Dr. R.P Centre AIIMS

South
DELHI
110029
India 
Phone    
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Namrata Sharma 
Designation  Professor Department of ophthalmology 
Affiliation   
Address  Room number 481 Fourth floor Dr. R.P Centre AIIMS

South
DELHI
110029
India 
Phone    
Fax    
Email  namrata.sharma@gmail.com  
 
Source of Monetary or Material Support  
Care Group Sight Solution LLP 
 
Primary Sponsor  
Name  Care Group Sight Solution LLP 
Address  26.A GANDHI OIL MILL COMPOUND NEAR B.I.D.C,GORWA VADDARA-390016 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 
Namrata Sharma  R.P Centre  AIIMS New Delhi
South
DELHI 
9810856988

namrata.sharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tecnis toric  Group 2: 20 eyes will undergo cataract removal and tecnis toric IOL implantation 
Intervention  Ultima smart toric  Group 1: 20 eyes will undergo cataract removal and Ultima smart toric IOL implantation 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age related senile cataract
2. Regular corneal astigmatism more than 1.25 D 
 
ExclusionCriteria 
Details  a) Presence of other associated ocular co-morbidities such as glaucoma, uveitis, or any posterior segment pathology.

b) Patients with irregular corneal astigmatism due to corneal scarring or other corneal abnormalities

c) Patient not willing to participate or follow up in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Uncorrected visual acuity
2. Post-operative IOL rotation  
baseline, 1 week, 1 month, 3 months and at 6 months follow up visit. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Higher order aberrations
2. Contrast sensitivity and glare acuity
 
baseline, 1 week, 1 month, 3 months and at 6 months follow up visit. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   01/07/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/07/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   data will be sent for publication once the recruitment is complete.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

      This is a prospective, randomized study designed to compare two types of toric intraocular lenses; the tecnis toric IOL and the Ultima smart toric IOL. The study will involve 40 eyes with age related senior cataract and regular corneal astigmatism more than 1.25 D. These will be randomly allocated in 2 groups based on computer generated random number table. Group 1 will include 20 eyes which will undergo Ultima smart toric IOL implantation while Group 2 will include 20 eyes which will undergo tecnis toric IOL implantation. Parameters which will be assessed include uncorrected and best corrected visual acuity, change in keratometric and refractive cylinder, endothelial cell count, intraocular pressure, higher order aberrations, postoperative IOL rotation, contrast sensitivity and glare acuity. All these investigations will be performed at baseline, 1 week, 1 month, 3 months and at 6 months follow up visit.


 
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