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CTRI Number  CTRI/2015/12/006464 [Registered on: 31/12/2015] Trial Registered Prospectively
Last Modified On: 28/04/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   study to assess use of laser for cataract surgery in cataracts of late stage (Intumescent cataracts) 
Scientific Title of Study   Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CTW860-P001 Version 1, 22 Dec 2014  Protocol Number 
NCT02403206  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Matthew Kurian 
Designation  Consultant Cataract and Refractive Services 
Affiliation  Narayana Nethralaya (NN1) 
Address  Narayana Nethralaya, 121/C, Chord Road, Rajaji Nagar Bangalore

Bangalore
KARNATAKA
560010
India 
Phone  8050056113  
Fax    
Email  dr.mkurian@narayananethralaya.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Salman Anzer 
Designation  Regional Manager 
Affiliation  Alcon Laboratories Pvt Ltd (India) 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield Bangalore

Bangalore
KARNATAKA
560048
India 
Phone  08040064683  
Fax    
Email  salman.anzer@alcon.com  
 
Details of Contact Person
Public Query
 
Name  Dr Salman Anzer 
Designation  Regional Manager 
Affiliation  Alcon Laboratories Pvt Ltd (India) 
Address  3rd Floor, Crescent 4, Prestige Shantiniketan, Whitefield Bangalore

Bangalore
KARNATAKA
560048
India 
Phone  08040064683  
Fax    
Email  salman.anzer@alcon.com  
 
Source of Monetary or Material Support  
Alcon laboratories India pvt Ltd 
 
Primary Sponsor  
Name  Alcon laboratories India pvt Ltd 
Address  Crescent 4, 3rd floor ,Prestige Shantiniketan , Bangalore 560048 Karnataka 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhay R Vasavada  Iladevi Cataract and IOL Center  Gurukul Road, Memnagar, Ahmedabad – 380052, Gujarat,India
Ahmadabad
GUJARAT 
9825700378

icirc@abhayvasavada.com 
DrMatthew Kurian  Narayana Nethralaya (NN1)  Narayana Nethralaya, 121/C, Chord Road, Rajaji Nagar Bangalore-560010
Bangalore
KARNATAKA 
8050056113

dr.mkurian@narayananethralaya.com 
Dr Himanshu Matalia  Narayana Nethralaya (NN2)  Narayana Nethralaya, (NN2) #258 A, Narayana Health City Campus Bommasandra, Hosur Road Bangalore-560099
Bangalore
KARNATAKA 
080-66660707

himanshu@narayananethralaya.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Iladevi Cataract and IOL Research Ethics Committee  Approved 
Narayana Nethralaya Ethics Committee  Approved 
Narayana Nethralaya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  With an intumescent cataract eligible for cataract surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LenSx Femtosecond Laser assisted Capsulotomy  One time 
Comparator Agent  standard continuous curvilinear capsulorhexis  One time 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adults, 21 years of age or older who are willing to undergo cataract surgery
2. Able to lie flat in a supine position
3. Able to understand and sign the Informed Consent Form (ICF)
4. Subjects must present with intumescent white cataract, with a liquid pressurized bag
and a milky, liquid cortex 
 
ExclusionCriteria 
Details  1. Subjects who refuse to sign the informed consent
2. Pregnant or lactating mothers
3. Corneal disease that precludes application of the cornea or transmission of laser light
at 1030 nanometer (nm)wavelength
4. Descemetocele with impending corneal rupture
5. Corneal opacity that would interfere with the laser beam
6. Presence of blood or other material in the anterior chamber
7. Hypotony or presence of corneal implant
8. Poorly dilating pupils, such that the iris is not peripheral to the intended diameter for
the capsulotomy
9. Condition which would cause inadequate clearance between the intended capsulotomy
depth and the endothelium
10. Residual, recurrent, active ocular or eye lid disease, including any corneal abnormality
(for example, recurrent corneal erosion, severe basement membrane disease)
11. A history of lens or zonular instability
12. Any contraindication to cataract surgery
13. Corneal thickness requirements that are beyond the range of the LenSx Laser system
(More than 1200 μ)
14. Subjects who in the opinion of the investigator are not good candidates for the trial
15. Subjects whose postoperative best corrected visual potential is expected to be worse
than 20/40 Snellen (0.3 logMAR) at the final study visit 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To demonstrate lower anterior or posterior capsule tear rate
with femtosecond laser assisted capsulotomy than standard
continuous curvilinear capsulorhexis (CCC) 
on the day of the surgery (i.e. Visit 00) 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate less operating time in the eye to complete the
entire cataract procedure with the femtosecond laser assisted
capsulotomy than standard CCC 
on the day of the surgery (i.e. Visit 00) 
 
Target Sample Size   Total Sample Size="425"
Sample Size from India="120" 
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   Phase 4 
Date of First Enrollment (India)   04/01/2016 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  26/03/2015 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Cataract surgery is the most commonly performed operative procedure today with
phacoemulsification being universally accepted as the best method of cataract extraction
(Vajpayee 1999). Phacoemulsification has the advantages of small incision and early visual
rehabilitation. However, phacoemulsification has been considered relatively unsuitable for
challenging case such as hypermature cataracts (Vajpayee 1999) and intumescent white
cataracts (Conrad-Hengerer 2014) because these cases may have increased intracapsular
pressure due to liquefaction of the cortex and a hard or brunescent nucleus underlying an
anterior/posterior cortical opacity. In intumescent cataracts, the structural causes of tensile
weakness were confirmed with ultra-structural analysis of the anterior capsule of the
intumescent cataract. While the analysis showed no increase in thickness, it did indicate
extrusions of basement membrane filaments at the basement membrane epithelial border,
rarefication, perpendicular lucent areas with fibrillary material and lamellae (Hawlina 2011).
These findings represent weak points for capsular stretching, pressure, longitudinal splitting
along the lamellae and tearing to the periphery. Therefore, the most difficult step of cataract
surgery in these cases is the creation of a continuous capsulorhexis without further anterior
capsule complication
The introduction of femtosecond laser for ophthalmic application provides another method for
cutting tissues within the eye. These lasers have been used in ophthalmology for many years.
The most common application is for the creation of corneal flaps but in recent years the
technology has been introduced in cataract surgery. The femtosecond laser assists with all the
key steps in cataract surgery prior to phacoemulsification namely: creation of corneal
incisions, anterior capsulotomy and lens fragmentation (Roberts 2013).
Phacoemulsification requires the creation of a manual
capsulotomy using a surgical cystotome to puncture the capsular bag. This procedure, known
as continuous curvilinear capsulorrhexis (CCC), can be associated with extension of the torn
capsular edge. Such tears weaken and compromise the integrity of the capsule and may lead
to vitreous loss, and the inability to safely place a posterior chamber IOL. The rate of such
complications, about 1%, is not insignificant (Marques 2006).
Phacoemulsification requires the creation of a manual
capsulotomy using a surgical cystotome to puncture the capsular bag. This procedure, known
as continuous curvilinear capsulorrhexis (CCC), can be associated with extension of the torn
capsular edge. Such tears weaken and compromise the integrity of the capsule and may lead
to vitreous loss, and the inability to safely place a posterior chamber IOL. The rate of such
complications, about 1%, is not insignificant (Marques 2006).
The aim of LenSx Laser is to apply the known safety and accuracy of femtosecond lasers,
combined with OCT targeting, to cataract surgery. Considering the features offered by the
LenSx Laser, the following device benefits are balanced against the risks mentioned above.
• For capsulotomy, the LenSx Laser produces anterior capsulotomy whose sizes are
statistically more uniform, accurate, and predictable than those produced by manual
techniques. By providing well-centered and uniform capsulotomy, the placement and
performance of IOL’s is expected to improve.
• For corneal incisions, the benefit of femtosecond laser treatment is well understood.
The LenSx Laser extends these benefits to the creation of uniform, surgeon-chosen
corneal incisions for cataract surgery.
In challenging cases such as patients with intumescent cataracts where visibility of the capsule
can be compromised, this can provide a significant benefit to complete the most difficult step
with minimal risk. In addition, it allows the surgeon to create a customized multi-plane
corneal incision that will be challenging to create manually

 
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