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
|
|
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
|
|
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.
|