| CTRI Number |
CTRI/2024/06/068809 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study Of Computer Guided And Smartphone App Assisted Toric IOL Placement Is One Better Than Other |
|
Scientific Title of Study
|
Comparison Of Clinical Outcomes Of Computer Assisted And Smartphone Based Target Axis Alignment For Toric Intra Ocular Lens Implantation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arya S S |
| Designation |
PG Resident |
| Affiliation |
Base Hospital, Delhi Cantt |
| Address |
Department of Ophthalmology, Base Hospital, Delhi Cantonment, South West Delhi, Delhi, 110010
South West
DELHI
110010
India |
| Phone |
8590492232 |
| Fax |
|
| Email |
aryavishnu23@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lt Col Piyush K Chaturvedi |
| Designation |
Professor |
| Affiliation |
Base Hospital, Delhi Cantt |
| Address |
Department of Ophthalmology, Base Hospital, Delhi Cantonment, South West Delhi, Delhi, 110010
South West
DELHI
110010
India |
| Phone |
9888023759 |
| Fax |
|
| Email |
mymailbox.pc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lt Col Piyush K Chaturvedi |
| Designation |
Professor |
| Affiliation |
Base Hospital, Delhi Cantt |
| Address |
Department of Ophthalmology, Base Hospital, Delhi Cantonment, South West Delhi, Delhi, 110010
South West
DELHI
110010
India |
| Phone |
9888023759 |
| Fax |
|
| Email |
mymailbox.pc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Base Hospital Delhi Cantonment,
South west Delhi, Delhi-110010 India |
|
|
Primary Sponsor
|
| Name |
Dr Arya S S |
| Address |
Department of Ophthalmology Base Hospital, Delhi Cantonment, South West Delhi, Delhi |
| Type of Sponsor |
Other [self] |
|
|
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 Arya S S |
Base Hospital, Delhi Cantt |
Department of Ophthalmology Base Hospital, Delhi Cantonment, South West Delhi, Delhi
South West
DELHI |
8590492232
aryavishnu23@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BASE HOSPITAL AND ARMY COLLEGE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H590||Disorders of the eye following cataract surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Computer assisted axis marking for Toric IOL implantation during cataract surgery |
First arm- Intraop Computer assisted axis marking is done for alignment of the Toric IOL during cataract surgery and clinical outcome in terms of alignment of the axis with respect to the calculated axis,unaided as well as best corrected visual acuity and residual astigmatism will be studied on Post-op day 1,7 and 30. Thus patient will be followed up for 01 month duration. |
| Comparator Agent |
Smart phone based axis marking for Toric IOL implantation during cataract durgery |
Second arm- Smart phone based app is used for marking the axis at which the Toric IOL is to be aligned during the catarct surgery and results in terms of alignment of the axis of IOL with the calculated axis, visual acuity and residual astigmatism will be studied on post-op day 1,7 and 30 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients above 18 years and below 80 years 2.Diagnosed with cataract and planned to undergo phacoemulsification and toric monofocal IOL implantation.
3.Patients having regular corneal astigmatism of more than 1.2 and axial length between 22mm and 23.5mm |
|
| ExclusionCriteria |
| Details |
1.Irregular corneal astigmatism
2.Previous intraocular or corneal surgeries
3.Intraoperative complications compromising toric IOL position such as zonular damage, vitreous loss, capsulorrhexis tear, posterior capsular rupture or any condition which could interfere with the visual outcome
4.Those with the postoperative findings of high myopia, glaucoma, retinal disease, postoperative miosis, prolonged postoperative iritis, etc. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure angular deviation IOL alignment of computer aided axis mark from the target axis vs angular deviation of IOL alignment of smartphone-assisted mark from the target axis, compare the best corrected visual acuity and postoperative residual astigmatism |
Postop day 1, 7 and 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparison of best corrected visual acuity (BCVA) and postoperative residual astigmatism. |
Postop day 1, 7 and 30 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
31/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is an randomized parallel group trial to study and compare the clinical outcomes of Computer assisted and Smartphone based target axis marking for the implantation of a toric intra ocular lens during cataract surgery for patients with regular corneal astigmatism of more than 1.2 DCYL, which will be conducted at Base hospital, Department of Ophthalmology ( teritiary care hospital ) in India. The primary outcome is to measure the final axis deviation of Toric IOL from the calculated axis with the above said methods of axis marking. The secondary outcome is to measure and compare the best corrected visual acuity and postoperative residual astigmatism in both cases. |