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CTRI Number  CTRI/2023/11/060210 [Registered on: 23/11/2023] Trial Registered Prospectively
Last Modified On: 22/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Retinal perfusion and varying IOP levels during cataract surgery 
Scientific Title of Study   Clinical evaluation of retinal perfusion when performing cataract surgery with low vs high preset IOP in eyes with diabetic retinopathy 
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 Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  101, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
101, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
Ahmadabad
GUJARAT
380052
India 
Phone  9825700378  
Fax    
Email  icirc@abhayvasavada.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  101, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
01, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
Ahmadabad
GUJARAT
380052
India 
Phone  9825700378  
Fax    
Email  icirc@abhayvasavada.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay R Vasavada 
Designation  Director 
Affiliation  Raghudeep Eye Hospital 
Address  101, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
01, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
Ahmadabad
GUJARAT
380052
India 
Phone  9825700378  
Fax    
Email  icirc@abhayvasavada.com  
 
Source of Monetary or Material Support  
Alcon Laboratories, USA 
 
Primary Sponsor  
Name  Alcon Laboratories USA 
Address  6201,South freeway,Fort Worth, Texas 76134  
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Abhay Vasavada  Raghudeep Eye Hospital  Cataract Department, Raghudeep Eye Hospital, Near ShreejiComplex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052India Ahmadabad GUJARAT 380052 India
Ahmadabad
GUJARAT 		 9825700378

icirc@abhayvasavada.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IladeviCataract &IOLResearchCentreEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  effect of Phacoemulsification using a physiological IOP(20mmHg) and a high IOP (55 mmHg)  Cataract Surgery on the Centurion Vision System with Active Fluidics and Active Sentry handpiece with two preset IOPs – 20mmHg vs 55mmHg Eyes undergoing cataract surgery will be randomized to: group I (low IOP,20mmHg) or group II (high IOP, 55mmHg). Icare tonometry to measure IOP will be performed at the time of preoperative OCTA, just before beginning of the surgery, immediately following stromal hydration of the incisions, and immediately prior to performing the postoperative OCTA. 
Comparator Agent  effect of Phacoemulsification using a physiological IOP(20mmHg) and a high IOP (55 mmHg)  Cataract Surgery on the Centurion Vision System with Active Fluidics and Active Sentry handpiece with two preset IOPs – 20mmHg vs 55mmHg Eyes undergoing cataract surgery will be randomized to: group I (low IOP,20mmHg) or group II (high IOP, 55mmHg). Icare tonometry to measure IOP will be performed at the time of preoperative OCTA, just before beginning of the surgery, immediately following stromal hydration of the incisions, and immediately prior to performing the postoperative OCTA.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age-related cataract with coexisting diabetic retinopathy (mild, moderate nonproliferative diabetic retinopathy with or without diabetic retinopathy) 
 
ExclusionCriteria 
Details  Proliferative diabetic retinopathy with tractional disease or proliferative vitreoretinopathy

Prior ocular trauma or surgery

 
 
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 
For Posterior Pole (macula) perfusion: Retinal vessel density & Perfusion density at superficial retinal layers at the posterior pole detected by OCTA at the following time points: within 2 hours of surgery, 1 day & 1 month postoperatively  1) 1 day postoperatively - To capture OCT angiography, anterior chamber inflammation

2) 1 week postoperatively To document anterior chamber inflammation
3) 1 month postoperatively To document OCT angiography
 
 
Secondary Outcome  
Outcome  TimePoints 
For Optic nerve head perfusion: Perfusion & Flux index at the RPC layer detected by OCTA at the following time points: within 2 hours of surgery, 1 day & 1 month postoperatively Cumulative Dissipated Energy
Fluid Used
Patient comfort during surgery (VAS scale)
Anterior chamber inflammation: measured on the slitlamp on postoperative day 1 & week 1
 		 None 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   02/12/2023 
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="3"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [icirc@abhayvasavada.com].

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 01-01-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

To study the effect of Phacoemulsification using  different IOP settings,  IOP 20mmHg and  IOP 55 mmHg on the retinal  macular circulation in patients having mild non proliferative diabetic retinopathy undergoing cataract surgery.

 
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