| CTRI Number |
CTRI/2018/05/013555 [Registered on: 01/05/2018] Trial Registered Prospectively |
| Last Modified On: |
20/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare outcomes of IOL implantation in cataract surgery using the VERION Image Guided System and ORA (Optiwave Refractive Analysis) wavefront aberrometer
|
|
Scientific Title of Study
|
A Pilot study to compare outcomes of IOL implantation in cataract surgery using the VERION Image Guided System and ORA (Optiwave Refractive Analysis) wavefront aberrometer
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof J S Titiyal |
| Designation |
Professor, Department of Ophthalmology ,AIIMS |
| Affiliation |
AIIMS,Delhi,India |
| Address |
AIIMS
Ansari Nagar East
South
DELHI
110029
India |
| Phone |
9810649942 |
| Fax |
|
| Email |
titiyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof J S Titiyal |
| Designation |
Professor, Department of Ophthalmology ,AIIMS |
| Affiliation |
AIIMS,Delhi,India |
| Address |
AIIMS
Ansari Nagar East
South
DELHI
110029
India |
| Phone |
9810649942 |
| Fax |
9810649942 |
| Email |
titiyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof J S Titiyal |
| Designation |
Professor, Department of Ophthalmology ,AIIMS |
| Affiliation |
AIIMS,Delhi,India |
| Address |
AIIMS
Ansari Nagar East
South
DELHI
110029
India |
| Phone |
9810649942 |
| Fax |
|
| Email |
titiyal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar East
110029
Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Prof J S Titiyal |
Dr R P Centre for Ophthalmic Sciences |
Unit 3 HOD Office ,Room 421,Dr R P Centre for Ophthalmic Sciences
AIIMS
New Delhi
INdia 110029
South
DELHI |
01126593146
titiyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ORA arm |
IOL implantation calculated on the basis of ORA |
| Comparator Agent |
Verion arm |
IOL implantation based on calculation by Verion image guided system |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Systemically fit patients undergoing cataract surgery, willing to give consent |
|
| ExclusionCriteria |
| Details |
Systemically unfit patient
Unwilling to give consent
With ocular comorbidity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Uncorrected distance visual acuity
Astigmatism |
Post operative day 1 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Refractive astigmatism
Best corrected visual acuity
Change in ocular aberrations |
Post operative day 1 and day 30 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
01/05/2018 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We would like to compare the visual outcomes in patients who are undergoing cataract surgery with Toric intraocular lens implanatation. IOL to be implanted will be based on the calculations by ORA and Verion image guided system respectively in the 2 arms. Recruitment to start after obtaining Ethics committee approval |