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CTRI Number  CTRI/2025/05/087449 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Study Outcomes of Cataract Surgery in Eyes with Coloboma 
Scientific Title of Study   Cataract surgery with associated coloboma: predictors of outcome and safety of different surgical techniques 
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 Ashish Sharma 
Designation  Post Graduate Student  
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department Of Ophthalmology,Ground Floor AVBRH building ,Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  7798166923  
Fax    
Email  sharma.ashish23788@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashank Banait 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department Of Ophthalmology,Ground Floor AVBRH building ,Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9822226124  
Fax    
Email  shashankbanait@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shashank Banait 
Designation  Associate Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department Of Ophthalmology,Ground Floor AVBRH building ,Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  9822226124  
Fax    
Email  shashankbanait@yahoo.co.in  
 
Source of Monetary or Material Support  
Datta Meghe Institute Of Higher Education and Research, Sawangi Meghe, Wardha,India 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute Of Higher Education and Research 
Address  Sawangi Meghe, Wardha,India 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Sharma  Acharya Vinobha Bhave Rural Hospital  Department of Ophthalmology AVBRH building Ground floor Sawangi Meghe
Wardha
MAHARASHTRA 
7798166923

sharma.ashish23788@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q130||Coloboma of iris, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Manual Small Incision Cataract Surgery  A scleral corneal tunnel will be made in patients with Iris Coloboma and capsulorhexis will be done after placing the CTR ring and lens will be implanted in 20 minutes  
Comparator Agent  Phacoemulsification  Clear Corneal Incision will be made in patients with Iris Coloboma and then pupil will be enlarged using the CTR ring and capsulorhexis will be done and lens will be implanted in 15 minutes 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with coloboma and having cataract
2. Patients with no history of previous ocular surgery in operating eye
 
 
ExclusionCriteria 
Details  1. Patients having other ocular comorbidities injuries or surgery
2. Cases with premature entry or where valve could not be formed properly 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improved postoperative visual outcomes and reduced surgical complications  Assessment will be made at postoperative six weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/06/2025 
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="2"
Months="0"
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  

Coloboma, a congenital defect  due to  incomplete embryonal fissure closure, often affects the infero-nasal part of the fundus & is frequently associated with cataracts, a leading treatable cause of visual impairment. However, cataract surgery in colobomatous eyes presents significant challenges due to anatomical anomalies such as microcornea, zonular instability, poor pupillary dilation, & structural irregularities. This hospital-based observational study, done at Ophthalmology Department Acharya Vinobha Bhave Rural Hospital, Sawangi, over two years aiming to evaluate the outcomes & safety of cataract surgery techniques, including phacoemulsification (PE) & manual small incision cataract surgery (M-SICS). The surgery type will depend on the degree of microcornea, cataract hardness, & zonular stability. Preoperative, intraoperative, & postoperative assessments will include detailed ophthalmic evaluations, visual acuity measurements, grading of microcornea, & complications such as corneal edema, using standardized grading systems. Statistical analysis using SPSS will identify predictors of surgical outcomes, with significance at p < 0.05. The study seeks to improve surgical techniques, enhance patient safety, & provide insights into counselling & risk stratification for individuals with coloboma-associated cataracts. By considering these challenges, the study  aims to optimize functional outcomes & quality of life for affected patients.  The study is expected to demonstrate improved postoperative visual outcomes, reduced surgical complications, & enhanced safety in cataract surgery for colobomatous eyes.


 
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