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CTRI Number  CTRI/2024/04/065023 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 29/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of corneal wound characteristics and post-operative visual outcomes with two different incision sizes - 2.2mm vs 2.8mm during IOL implantation in phacoemulsification surgery in patients with age related cataract 
Scientific Title of Study   Comparison of 2.2 mm vs 2.8 mm clear corneal wound characteristics following wound assisted IOL injection 
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. Rajeshwari Kapoor 
Designation  DNB Resident 
Affiliation  Aravind Eye Hospital 
Address  Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee

Chennai
TAMIL NADU
600077
India 
Phone  9811616222  
Fax    
Email  rajeshwari.kapoor@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Seema Ramakrishnan 
Designation  Consultant, Cornea and Refractory Surgery Services 
Affiliation  Aravind Eye Hospital 
Address  105, Department of Cornea and Refractory Surgery Services Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee

Chennai
TAMIL NADU
600077
India 
Phone  9884848224  
Fax    
Email  seemadr@aravind.org  
 
Details of Contact Person
Public Query
 
Name  Dr. Seema Ramakrishnan 
Designation  Consultant, Cornea and Refractory Surgery Services 
Affiliation  Aravind Eye Hospital 
Address  105, Department of Cornea and Refractory Surgery Services Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee

Chennai
TAMIL NADU
600077
India 
Phone  9884848224  
Fax    
Email  seemadr@aravind.org  
 
Source of Monetary or Material Support  
Aravind Eye Hospital, Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee Chennai, 600077 Tamil Nadu India 
 
Primary Sponsor  
Name  Rajeshwari Kapoor 
Address  Aravind Eye Hospital Poonamallee High Road Noombal Chennai Tamil Nadu 600077 
Type of Sponsor  Other [Self] 
 
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 
Rajeshwari Kapoor  Aravind Eye Hospital  105, Department of Cornea and Refractory Surgery Services Poonamallee High Rd, opposite Saveetha Dental College, Numbal, Poonamallee
Chennai
TAMIL NADU 
9811616222

rajeshwari.kapoor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Aravind Eye Hospital, Chennai (IEC-AEH CHN)  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  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with age related cataract
Age 45 years and above
Patients undergoing phacoemulsification surgery
Phacoemulsification surgery done through a temporal incision
Patients with intraocular lens power ranging from plus 18D to plus 25D
Willing to participate in the study
Willing for follow up visits
 
 
ExclusionCriteria 
Details  Pterygium Grade II and Grade III
Previous ocular surgery
Pre existing irregular astigmatism
Corneal opacity
Patients with Fuchs endothelial corneal dystrophy or significant guttata seen preoperatively
Patients with arcus senilis
Intraoperative obvious wound extension, tear or Descemet membrane detachment noted before IOL implantation
Frank clinically significant DMD happening at the step of wound hydration, when it was not noticed prior to that point
Intraoperative posterior capsular rent and zonular dehiscence
Intraoperative use of iris hooks 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Comparison of incidence of wound site Descemet membrane detachment in the three groups  Intra operatively
Post operative day 1
Post operative day 21 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of IOL safety   Intra operatively 
Comparison of wound size extension   Intra operatively 
Comparison of keratometry and surgically induced astigmatism  Post operative day 21
Post operative day 90 
 
Target Sample Size   Total Sample Size="99"
Sample Size from India="99" 
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)   08/04/2024 
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="6"
Days="0" 
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 - NO
Brief Summary  

This study aims to evaluate wound extension, IOL safety, Descemet membrane detachment and surgically induced astigmatism in phacoemulsification surgery using the wound assisted technique of IOL implantation and to study their relationship with incision size.

This will be a prospective, observational study conducted at Aravind Eye Hospital, Chennai. All surgeries will be performed by 4 experienced surgeons, using the Centurion Phacoemulsification system under topical or sub-Tenon’s anaesthesia. Surgery will be performed via standard clear corneal incisions of either 2.2mm or 2.8mm size depending on the intraocular lens that the patient has chosen. Once the cataract has been removed from the eye, the incision size will be measured by a device called incision gauge. Following this, the IOL will be injected through this incision inside the eye. The surgeon will once again measure the incision size after this step. The surgery would be concluded as usual. In the event of detecting any nicks, scratches or breaks of the intraocular lens (IOL) during its insertion, their presence will be duly observed and documented by the surgeon. ASOCT will be done for all patients to analyse wound size, wound gape and non-apposition of the incision and detect the presence of Descemet membrane detachment on post-operative day 1 and post-operative day 21. Biometry will be done for all participants pre-operatively, on post-operative day 21 and on post-operative day 90 to check for keratometry and surgically induced astigmatism.

 
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