| CTRI Number |
CTRI/2019/05/019157 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
10/05/2019 |
| 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 toric Implantabe Contact Lens (ICL) with toric Implantable Phakic Contact lens (IPCL) |
|
Scientific Title of Study
|
Comparative evaluation of clinical outcomes of toric Implantabe Contact Lens (ICL) versus toric Implantable Phakic Contact lens (IPCL) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Namrata Sharma |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room No. 481, Fourth floor
Dr. R.P Centre for Ophthalmic Sciences
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Namrata Sharma |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room No. 481, Fourth floor
Dr. R.P Centre for Ophthalmic Sciences
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Namrata Sharma |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room No. 481, Fourth floor
Dr. R.P Centre for Ophthalmic Sciences
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, GANDHIOIL MILL COMPOUND
NEAR B.I.D.C, GORWA
VADODARA- 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 |
Dr. R.P Centre |
Ansari Nagar
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: H521||Myopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ICL |
Group 1: 20 eyes will undergo toric ICL implantation |
| Intervention |
IPCL |
Group 2: 20 eyes will undergo toric IPCL implantation |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
40 eyes, with high myopia and 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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Postoperative emmetropia
2. Phakic lens stability
|
Baseline, 1 week, 1 month, 3 months and at 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post operative higher order aberrations
2. Contrast sensitivity and glare acuity
3. Endothelial cell status
4. Intraocular pressure |
Baseline, 1 week, 1 month, 3 months and at 6 months |
|
|
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
|
not yet published |
|
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 phakic lenses; the toric ICL and the toric IPCL. The study will involve 40 eyes with high myopia with 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 toric ICL implantation while Group 2 will include 20 eyes which will include 20 eyes which will undergo toric IPCL implantation. Parameters which will be assessed include uncorrected and best corrected visual acuity, keratometric and refractive cylinder, endothelial cell count, intraocular pressure, higher order aberrations, lens 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. ii. x. |