| CTRI Number |
CTRI/2016/03/006699 [Registered on: 03/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
02/03/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing methods to align lens placed in eye after cataract surgery |
|
Scientific Title of Study
|
Toric Intraocular Lens Alignment- Comparison of Image Guided Surgery with Manual Axis Marking |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeewan S Titiyal |
| Designation |
Professor & Head, Cornea, Cataract & Refractive Services |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Room No 491, Dr R P Centre, All India Institute of Medical Sciences (AIIMS), New Delhi
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
Titiyal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeewan S Titiyal |
| Designation |
Professor & Head, Cornea, Cataract & Refractive Services |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Room No 491, Dr R P Centre, All India Institute of Medical Sciences (AIIMS), New Delhi
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
Titiyal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeewan S Titiyal |
| Designation |
Professor & Head, Cornea, Cataract & Refractive Services |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Room No 491, Dr R P Centre, All India Institute of Medical Sciences (AIIMS), New Delhi
South
DELHI
110029
India |
| Phone |
01126593146 |
| Fax |
|
| Email |
Titiyal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr R P Centre, All India Institute of Medical Sciences (AIIMS) |
|
|
Primary Sponsor
|
| Name |
Dr RP Centre for Ophthalmic Scienmces |
| Address |
All India Institute of Medical Sciences (AIIMS)
New 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 |
| Dr Jeewan S Titiyal |
Dr R P Centre |
All India Institute of Medical Sciences (AIIMS)
South
DELHI |
01126593146
Titiyal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences (AIIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cataract with astigmatism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cataract surgery, phacoemulsification, Toric Intraocular lens |
CALLISTO Eye and Z Align
|
| Comparator Agent |
Cataract surgery, phacoemulsification, Toric Intraocular lens |
Nuijts Lane Toric Reference Marker, bubble marker |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing cataract surgery after providing an informed consent
Regular Astigmatism from 1.5 dioptres to 6 dioptres
Pupil dilatation of atleast 6mm
No ocular or systemic illness |
|
| ExclusionCriteria |
| Details |
Patients with pre existing glaucoma
Patients with retinal pathology
Patients with small pupils
Patients with systemic illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Deviation of Toric IOL alignment from the target axis |
Postoperative day 1 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual acuity, residual astigmatism |
Postoperative day 1 and day 30 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/12/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Randomised control trial to evaluate image guided surgery with manual axis marking in the alignment of Toric IOLs |