| CTRI Number |
CTRI/2018/12/016584 [Registered on: 10/12/2018] Trial Registered Prospectively |
| Last Modified On: |
15/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the Safety of Femtosecond Laser assisted Cataract Surgery (FLACS) and comparing it with Phacoemulsification Cataract Surgery (Phaco) in the hands of Junior Cataract Surgeons. |
|
Scientific Title of Study
|
Evaluating the Safety of Femtosecond Laser assisted Cataract Surgery (FLACS) and comparing it with Phacoemulsification Cataract Surgery (Phaco) in the hands of Junior Cataract Surgeons : Randomized, Masked, Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
Catarat Department,
Ground Floor, Room
No: 101, Gurukul Road,
Memnagar,
Ahmadabad
GUJARAT
Catarat Department,
Ground Floor, Room
No: 101, Gurukul Road,
Memnagar,
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT
380052
India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
1, Basement Seminar room, Gurukul Road,
Memnagar,
Ahmadabad
GUJARAT
1, Basement Seminar room, Gurukul Road,
Memnagar,
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT
380052
India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
1, Basement Seminar Room
1, Basement Seminar room, Gurukul Road,
Memnagar,
Ahmadabad
GUJARAT
1, Basement Seminar Room
Basement Seminar room, Gurukul Road,
Memnagar,
Ahmadabad
Ahmadabad
GUJARAT
380052
India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
|
Source of Monetary or Material Support
|
| Alcon Laboratories Inc.,Fortworth, USA |
|
|
Primary Sponsor
|
| Name |
Alcon Laboratiores Inc |
| Address |
6201 , South freeway ,Fort Worth , Texas 76134 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| Abhay Vasavada |
Raghudeep Eye Hospital |
Near Shreeji Complex, Gurukul Road, Memnagar, Ahmedabad
Ahmadabad
GUJARAT |
0917927490909
icirc@abhayvasavada.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Iladevi Cataract & IOL Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Uncomplicated age related cataracts, Nuclear Opalescence(NO) grade I to IV(LOCS III classification). Only one eye of each patient will be included |
|
| ExclusionCriteria |
| Details |
Ocular comorbidity, glaucoma, uveitis, previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Central Corneal Thickness, Corneal edema, Anterior Chamber Inflammation (anterior chamber cells and flare) at 1 day, 1 week and 1 month postoperatively |
1 day, 1 week and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Macular thickness at 1 month and 3 months, Corneal endothelial cell count and morphology at 6 months postoperatively, Visual Acuity (uncorrected and corrected) at 1 day, 1 week and 1, 3 months postoperatively |
1 day, 1 week, 1 month, 3 months and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="320"
Sample Size from India="320"
Final Enrollment numbers achieved (Total)= "320"
Final Enrollment numbers achieved (India)="320" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2018 |
| Date of Study Completion (India) |
30/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/06/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We wish to propose a Randomized, Masked
Clinical Trial comparing FLACS and Phaco in terms of its postoperative safety
outcomes – corneal thickness, corneal edema, anterior chamber cells and flare,
corneal endothelial cell count and morphology and macular thickness, in the
hands of a junior cataract surgeon. |