| CTRI Number |
CTRI/2021/12/038887 [Registered on: 23/12/2021] Trial Registered Prospectively |
| Last Modified On: |
04/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of post cataract surgery outcome in standard phacoemulsification versus newer femtosecond assisted cataract surgery machine in advanced cataract. |
|
Scientific Title of Study
|
Comparison of safety,efficacy and post operative endothelial cell density following standard phacoemulsification versus LENSAR femtosecond laser assisted cataract surgery in dense cataract. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman Managing Director |
| Affiliation |
Netradhama Superspeciality Eye hospital |
| Address |
Nethradhama Superspeciality Eye Hospital
256/14, Kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA Bangalore KARNATAKA 560082 India.
Nethradhama Superspeciality Eye Hospital
256/14, Kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA Bangalore KARNATAKA 560082 India.
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHEETAL BRAR |
| Designation |
SENIOR CONSULTANT AND RESEARCH DIRECTOR |
| Affiliation |
Netradhama Superspeciality Eye hospital |
| Address |
Nethradhama Superspeciality Eye Hospital
256/14, Kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA Bangalore KARNATAKA 560082 India.
Nethradhama Superspeciality Eye Hospital
256/14, Kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA Bangalore KARNATAKA 560082 India.
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
brar_sheetal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SANJALI WADHOKAR |
| Designation |
FELLOW PHACOREFRACTIVE |
| Affiliation |
Netradhama Superspeciality Eye hospital |
| Address |
Nethradhama Superspeciality Eye Hospital
256/14, Kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA Bangalore KARNATAKA 560082 India
Nethradhama Superspeciality Eye Hospital
256/14, Kanakapura main road,7th block , Jayanagar ,Bangalore KARNATAKA Bangalore KARNATAKA 560082 India.
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
sanjalitadas@yahoo.com |
|
|
Source of Monetary or Material Support
|
| LENSAR Inc
2800 discovery drive
Orlando,FL 32826 |
|
|
Primary Sponsor
|
| Name |
LENSAR |
| Address |
2800 Discovery Dr , Orlando,FL 32826,USA |
| Type of Sponsor |
Research institution |
|
|
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 Sanjali Tadas |
NETRADHAMA SUPERSPECIALITY EYE HOSPITAL |
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, Jayanagar, Bangalore, Karnataka
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8459994156
sanjalitadas@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama SuperSpeciality Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cataract |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Femtosecond assisted cataract surgery using LENSAR |
LENSAR femtosecond laser assisted cataract surgery followed by phacoemulsification by Oertli phacoemulsification machine for 1 year. |
| Intervention |
standard conventional phacoemulsification machine system |
using Oertli phacoemulsifiction machine system for 1 year |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with cataract grade 3 or more (according to LOCS III classification)
2.Subjects willing and able to understand and sign informed consent.
3.Subjects willing and able to attend postoperative examinations per protocol schedule.
|
|
| ExclusionCriteria |
| Details |
1.Patients with endothelial cell density less than 1500 cells/mm2
2.Pupil diameter less than 6mm or pupillary abnormality.
3.Subluxated cataract
4.Post uveitic cataract
5.Traumatic cataract
6.Corneal opacity
7.Pterygium greater than grade 2.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intra-operative cumulative dissipated energy (CDE), total surgical time and complication rates between the two groups. |
PRE OPERATIVE, INTRAOPERATIVE,FOLLOW UP DAY 1, FOLLOW UP 2 WEEKS, FOLLOW UP 6 MONTHS AND 1 YEAR. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| best corrected visual acuity, endothelial cell density,intraocular pressure. |
PRE OPERATIVE, INTRAOPERATIVE,FOLLOW UP DAY 1, FOLLOW UP 2 WEEKS, FOLLOW UP 6 MONTHS AND 1 YEAR. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
FLACS(Femtosecond assisted cataract surgery) is the deviced to give most precise, accurate results following cataract surgery. Several studies have been performed to check for safety and efficacy of FLACS vs standard phacoemulsification in harder cataract. LENSAR FS laser system has been introduced, which
incorporates Augmented Reality through advanced Scheimpflug imaging, ray
tracing and 3D confocal structured illumination (3D-CSI) to construct a
three-dimensional model of the anterior segment of the eye including the cornea
and lens.Turrets
software available in LENSAR FS system enables use of chop and fragmentation
patterns. It is an extended fragmentation region near the center of the
anterior capsule governed by two parameters: Max Turret Radius ( radial extent
of the turret) and Extend Turret ( extent of the turret above the capsule; must
be negative to avoid affecting the capsulotomy button). The software
consolidates 16 individual high resolution Scheimpflug images from 8 angular
positions to identify the major interfaces ie anterior and posterior corneal
surface and anterior and posterior lens capsule, details of the location and
density of the lens nucleus and the boundaries between endonucleus, epinucleus
and cortex , thus allowing automated grading of cataract density and
customization of phacofragmentation and reducing cumulative dissipated energy
(CDE) minimising potential for inflammation and endothelial cell loss.This prospective, non-randomized study will thus
be conducted to investigate the intra-operative
cumulative dissipated energy (CDE) and endothelial cell density (ECD) in dense
cataracts following standard
phacoemulsification surgery versus FLACS with LENSAR FS laser system over a
long term follow-up of 12 months. |