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CTRI Number  CTRI/2022/07/043955 [Registered on: 12/07/2022] Trial Registered Prospectively
Last Modified On: 26/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   A prospective study on a novel complication free technique for placing the intraocular lens in the sulcus when the cataract surgery is complicated by posterior capsular rent or zonular dialysis 
Scientific Title of Study   A sling to prevent Intraocular Lens swing- A prospective interventional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avik Kumar Roy 
Designation  Consultant, Glaucoma 
Affiliation  L V Prasad Eye Institute 
Address  Mithu Tulasi Chanrai Campus
Patia Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  7854804087  
Fax  06743987130   
Email  dravik@lvpei.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Avik Kumar Roy 
Designation  Consultant, Glaucoma 
Affiliation  L V Prasad Eye Institute 
Address  Mithu Tulasi Chanrai Campus
Patia Bhubaneswar

ORISSA
751024
India 
Phone  7854804087  
Fax  06743987130   
Email  dravik@lvpei.org  
 
Details of Contact Person
Public Query  
Name  Dr Jyoti Goyal 
Designation  DNB Resident 
Affiliation  L V Prasad Eye Institute 
Address  Mithu Tulasi Chanrai Campus
Patia Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  8800413256  
Fax  06743987130   
Email  jyoti.goyal0703@gmail.com  
 
Source of Monetary or Material Support  
Hyderabad Eye Research Foundation L V Prasad Eye Institute Mithu Tulasi Chanrai Campus, Patia Bhubaneswar 751024 Odisha, India. 
 
Primary Sponsor  
Name  Hyderabad Eye Research Foundation  
Address  L V Prasad Eye Institute MTC Campus Patia, Bhubaneswar Odisha 
Type of Sponsor  Research institution 
 
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 Avik kumar Roy  L V PRASAD EYE INSTITUTE  Academic Block Ground floor Clinical Research Department Mithu Tulasi Chanrai Campus Patia Bhubaneswar
Khordha
ORISSA 		 7854804087
06742653130
dravik@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, L V Prasad Eye Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H259||Unspecified age-related cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A 10-0 nylon suture sling  A 10-0 nylon suture will be used for placement of IOL in the sulcus in a cataract surgery when it will be complicated by PCR or ZD 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with intra operative PCR or ZD  
 
ExclusionCriteria 
Details  1) Intraop PCR/ZD where pupil became smaller than 3mm
2) Cases where ZD is too large >2 quadrants
3) Patients where lens material has dropped into posterior segment
4) Patients where ciliary sulcus support is inadequate
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Incidence of IOL stability—as documented in Slit lamp
2)Best corrected visual acuity (BCVA)

 		 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
IOL position as documented by Ultrasound Biomicroscopy  6 weeks 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   20/07/2022 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Among 20 million cataract surgeries being performed worldwide every year approximately 5% are being complicated by Posterior Capsular rent (PCR) and Zonular Dialysis (ZD). The next step in management of these complications is to place the IOL in the sulcus which involves the risk of IOL drop into the vitreous, the most dreadful event for a cataract surgeon when there is no vitreo-retinal backup available. So to reduce this risk, we have described a simple yet effective technique where 10-0 nylon suture will be passed through the dialing hole of a rigid single piece IOL and it will be used as a sling for the safe and centered placement of IOL in the sulcus. We will be doing a prospective interventional study incorporating this technique while performing cataract surgery when it will be complicated by intra-operative PCR or ZD. Post operatively, the patients will be followed up on day 1, week 1, 6 weeks, 3 months and 6 months to access IOL position and BCVA and to look for post operative complications. 
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