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CTRI Number  CTRI/2022/10/046205 [Registered on: 06/10/2022] Trial Registered Prospectively
Last Modified On: 30/09/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparing the change in distance between anterior surface of natural crystalline lens with posterior surface of phakic intraocular lens in varying light conditions for two different models of phakic intraocular lens.  
Scientific Title of Study   Comparison of dynamic vault changes following implantation of two different models of phakic intraocular lenses. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sheetal Brar 
Designation  Senior consultant and fellowship director 
Affiliation  Nethradhama Superspeciality Eye hospital 
Address  Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  9591002092  
Fax    
Email  brar_sheetal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjali Wadhokar 
Designation  Fellow phaco refractive department 
Affiliation  Nethradhama Superspeciality Eye hospital 
Address  Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  8459994156  
Fax    
Email  sanjalitadas@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjali Wadhokar 
Designation  Fellow phaco refractive department 
Affiliation  Nethradhama Superspeciality Eye hospital 
Address  Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore Bangalore KARNATAKA 560070 India

Bangalore
KARNATAKA
560070
India 
Phone  8459994156  
Fax    
Email  sanjalitadas@yahoo.com  
 
Source of Monetary or Material Support  
Nethradhama Superspeciality eye hospital, Bengaluru. 
 
Primary Sponsor  
Name  Nethradhama superspeciality eye hospital 
Address  156/14 Kanakapura rd opp ICICI Bank 7th Block Jayanagar Bengaluru 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 Sanjali Wadhokar  Nethradhama superspeciality eye hospital  Nethradhama SuperSpeciality Eye Hospital, 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bangalore
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H521||Myopia, (2) ICD-10 Condition: H522||Astigmatism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Myopia between -0.5 and -21 DS
2.Astigmatism between 0 to 6 DC 
 
ExclusionCriteria 
Details  1. Anterior chamber depth less than 2.8mm
2. Endothelial cell density less than 1500 cells/mm3
3. Cataract chanes in crystalline lens. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
changes seen in the phakic introcular lens vault in different light conditions is the primary outcome.  vault is to be measured post surgery first day, 2 weeks and three months 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse event at any follow up  2 weeks and 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/11/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published yet. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Eyecryl phakic or Eyecryl phakic toric IOL and Visian implantable collamer lens are posterior chamber phakic intraocular lens (pIOL) that have been reported to be safe and effective surgical option for correction of moderate to high myopia , hyperopia and astigmatism. Vault is the distance between anterior surface of crystalline lens and posterior surface of phakic iol. Low vault may lead to mechanical contact with the crystalline lens , which is responsible for high incidence of anterior capsular opacification and cataract formation. Conversely , excessively high vault causes mechanical contact between the pIOL and iris, resulting in inflammation , high intraocular pressure, angle closure glaucoma and pigment dispersion syndrome. As both models of pIOL are made up of different material , it will be interesting to evaluate the vault height in both brands in varying light conditions. In this is a prospective comparative  study we aim to compare the difference in dynamic vault between two lenses owing to difference in their material. 
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