FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/01/022660 [Registered on: 08/01/2020] Trial Registered Prospectively
Last Modified On: 02/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [femto capsulotomy flap in FLACS]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   To evaluate whether the laser made circular capsular flap technique is safe and efficacious in laser assisted cataract surgery for hard cataracts  
Scientific Title of Study   To evaluate the safety and efficacy of Femto capsulotomy flap technique in Femtosecond Laser assisted cataract surgery for Dense cataracts 
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 and MD Nethradhama superspeciality eye hospital 
Affiliation  Nethradhama superspeciality eye hospital  
Address  Phaco-refractive department, 2nd floor, OPD block, #256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082

Bangalore
KARNATAKA
560082
India 
Phone    
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sri Ganesh 
Designation  Chairman and MD Nethradhama superspeciality eye hospital 
Affiliation  Nethradhama superspeciality eye hospital  
Address  Phaco-refractive department, 2nd floor, OPD block, # 256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082

Bangalore
KARNATAKA
560082
India 
Phone    
Fax    
Email  phacomaverick@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sri Ganesh 
Designation  Chairman and MD Nethradhama superspeciality eye hospital 
Affiliation  Nethradhama superspeciality eye hospital  
Address  Phaco-refractive department, 2nd floor, OPD block, #256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082

Bangalore
KARNATAKA
560082
India 
Phone    
Fax    
Email  phacomaverick@gmail.com  
 
Source of Monetary or Material Support  
Nethradhama superspeciality eye hospital, #256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082 
 
Primary Sponsor  
Name  Nethradhama superspeciality eye hospital 
Address  #256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082 Karnataka 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sri Ganesh  Nethradhama superspeciality eye hospital  Phaco-refractive Department, 2nd Floor, OPD Block, #256/14, Kanakapura Main Road, 7th Block Jayanagar, Bangalore-560082
Bangalore
KARNATAKA 		 9845129740

phacomaverick@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee for research on human subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Femto capsulotomy flap in FLACS  To evaluate the safety and efficacy of femto capsulotomy flap technique in femtosecond laser assisted cataract surgery (FLACS) for dense cataracts and compare this with conventional FLACS (without flap technique) 
Comparator Agent  FLACS without flap technique  Femtosecond laser assisted cataract surgery without flap technique for dense cataracts to serve as control group 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Cataract grade NO4NC4 or more (according to LOCS III CLASSIFICATION) undergoing FLACS.
Subjects are willing and able to understand and sign an informed consent.
Subjects are willing and able to attend postoperative examinations per protocol schedule
 
 
ExclusionCriteria 
Details  1. Cataract grade less than NO4 NC4
2. Chronic uveitis
3. Endothelial cell density (ECD) less than 1500 cells/mm2
4. Pupil dilatation less than 6mm
5. Anterior chamber depth (ACD) equals to or less than VH2
6. Concurrent participation in another drug or device study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
UCVA, BCVA, ECD (endothelial cell density)  Time Frame: Pre-operative visit, 1 day, 15, 90, and 180 Days Follow-up 
 
Secondary Outcome  
Outcome  TimePoints 
1. Coefficient of variation of corneal endothelium
2. Corneal clarity (Grading of oedema) 		 1. Time Frame: Pre-operative visit, 1 day, 15, 90, and 180 Days Follow-up
2. Time Frame: Post-op day 1, 15, 90, and 180 Days Follow-up 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/01/2020 
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)?  

Brief Summary   This is a prospective, interventional, non-randomised, single centre, comparative study to evaluate the safety and efficacy (visual outcomes and endothelial cell density) of femto capsulotomy flap technique in femtosecond laser assisted cataract surgery for hard cataracts. 50 eyes fulfilling the inclusion and exclusion criteria undergoing femtosecond laser assisted cataract surgery(FLACS) to be performed by a single surgeon at Nethradhama superspeciality eye hospital will be included in the study. 25 eyes will be included in the FLACS with flap group and 25 eyes will be included in the FLACS only group which will serve as cases and controls, respectively. This technique involves attaching femto capsulotomy flap to the endothelial cell layer using viscoelastic devices to serve as mechanical barrier against ultrasound energy used during emulsification of hard cataracts. 
Close