| CTRI Number |
CTRI/2023/07/055833 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The purpose of the study is to check the position of the lens placed in eye after cataract surgery with new technique of image guided system. |
|
Scientific Title of Study
|
Comparison of toric intraocular lens alignment with intraoperative image guided system and conventional manual marking method- A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Nandan Tripathi |
| Designation |
Resident Ophthalmology |
| Affiliation |
Command Hospital(Eastern command) |
| Address |
Department of Ophthalmology Command Hospital(Eastern Command) Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
7307337090 |
| Fax |
|
| Email |
livelyamit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col (Dr) Santosh Kumar |
| Designation |
Professor |
| Affiliation |
Command Hospital(Eastern command) |
| Address |
Department of Ophthalmology Command Hospital(Eastern Command) Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
9602906343 |
| Fax |
|
| Email |
santo21051977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Nandan Tripathi |
| Designation |
Resident Ophthalmology |
| Affiliation |
Command Hospital(Eastern command) |
| Address |
Department of Ophthalmology Command Hospital(Eastern Command) Alipore Kolkata
Kolkata
WEST BENGAL
700027
India |
| Phone |
7307337090 |
| Fax |
|
| Email |
livelyamit@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Command Hospital Eastern Command |
| Address |
Command Hospital (Eastern Command) Alipore Kolkata-700027 |
| 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 Amit Nandan Tripathi |
Command Hospital (Eastern Command) |
Room No 3 Department of Ophthalmology
Kolkata
WEST BENGAL |
7307337090
livelyamit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMAND HOSPITAL(EC) INSTUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Toric intraocular lens alignment using conventional manual marking method. |
Patient with cataract and concomitant astigmatism 1.25 D or more will undergo toric intraocular lens alignment using conventional manual marking using bubble marker for 30 min |
| Intervention |
Toric intraocular lens alignment using intraoperative image guided system. |
Patient with cataract and concomitant astigmatism 1.25 D or more will undergo toric intraocular lens alignment using image guided Calisto eye and Z align image guided system for 30 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing cataract surgery aged 18 years and above.
2. Pre op astigmatism > 1.25 D |
|
| ExclusionCriteria |
| Details |
1.Any corneal/limbal pathology
2.Uveitis
3.Squint and Amblyopia
4.Pre-existing glaucoma
5.Retinal pathology
6.Irregular astigmatism
7.Pupil dilatation< 5mm
8.Eye requiring suture to seal the corneal incission at the end of surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in toric intraocular lens misalignment between intraoperative image guided system & conventional manual marking method will be accessed on post op day 1 and day 30. |
Day 1,Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure residual refractive cylinder & best corrected visual acuity. |
Day 30 |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/08/2023 |
| Date of Study Completion (India) |
20/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)
|
Toric intraocular lenses (IOL) have become the choice to correct corneal astigmatism of 1D or more in cases undergoing cataract surgery. Intraoperative toric intraocular lens alignment were initially done using conventional manual marking methods. However, with a recently introduced digital marking system, toric intraocular lens can be aligned without preoperative manual marking. The primary objective of this study is to measure difference in toric intraocular lens misalignment between intraoperative image guided system and conventional manual marking method. |