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CTRI Number  CTRI/2022/10/046938 [Registered on: 31/10/2022] Trial Registered Prospectively
Last Modified On: 28/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study of types and causes of cataract in patients aged between 20 to 50 years at a tertiary eye care center  
Scientific Title of Study   Analysis of clinical profile and risk factors of cataract in patients aged between 20 to 50 years at a tertiary eye care center  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pradeep G N 
Designation  RESIDENT (DNB) OPHTHALMOLOGY 
Affiliation  Sankara Eye Hospital  
Address  Sankara Eye Hospital Harakere Thirthahalli Road Shimoga
Harakere Thirthahalli Road Shimoga Karnataka India
Shimoga
KARNATAKA
577202
India 
Phone    
Fax    
Email  pradeepgn22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR MAHESHA S  
Designation  Consultant cataract & Trauma services 
Affiliation  Sankara Eye Hospital  
Address  Sankara Eye Hospital Harakere Thirthahalli Road Shimoga
Harakere Thirthahalli road Shimoga Karnataka India
Shimoga
KARNATAKA
577202
India 
Phone    
Fax    
Email  smaheshbhat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pradeep G N 
Designation  RESIDENT (DNB) OPHTHALMOLOGY 
Affiliation  Sankara Eye Hospital  
Address  Sankara Eye Hospital Harakere Thirthahalli Road Shimoga
Harakere thirthahalli road Shimoga Karnataka India
Shimoga
KARNATAKA
577202
India 
Phone    
Fax    
Email  pradeepgn22@gmail.com  
 
Source of Monetary or Material Support  
Sankara eye hospital harakere thirthahalli road Shimoga  
 
Primary Sponsor  
Name  Sankara eye hospital  
Address  Harakere thirthahalli road Shimoga  
Type of Sponsor  Research institution and hospital 
 
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 
PRADEEP G N  Sankara eye hospital   Room number 12 Department of cataract and trauma services
Shimoga
KARNATAKA 		 9591079636

pradeepgn22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Sankara eye hospital Shimoga   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H268||Other specified cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.patients who gave informed consent to participate in the study
2.patients of either gender presenting with cataract aged between 20 to 50 years either unilateral or bilateral will be included
3.patients with cataract secondary to uveitis  
 
ExclusionCriteria 
Details  1.patients with congenital or developmental cataracts. 2.patients with traumatic cataract  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the types and evaluate the risk factors of cataract in patients aged between 20 to 50 years   At baseline  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the various morphological types of cataract in patients aged between 20 to 50 years   First visit  
 
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   N/A 
Date of First Enrollment (India)   14/11/2022 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Cataract is thought to be the most common cause of blindness worldwide. Moreover,lens opacities have an early onset in Indians compared to the industrialized nations. The search for the alterable risk factors that affect the occurrence of cataract has prompted investigators to explore the possible links between cataract and the various modifiable associations 
Risk factors for the development of cataract include heredity, age, diabs, oral or inhaled steroid therapy, exposure to UV-B radiation, poor nutrition, cigarette smoking, alcohol consumption Cataract which develops beteefore the age of 50 years are called presenile cataract. Very few studies have analyzed the association between presenile cataract and the many associated risk factors. Adding to the various above mentioned associations, atopy and high myopia have shown to be considerably associated with the development of presenile cataract,  patients from different walks of life form the clientele of our sankara eye hospital shivamogga, a tertiary eye care centre, and each group may be exposed to distinctive set of risk factors due to the varied standard of living and access to healthcare. The present study will help us to understand better the relationship between the various associations of presenile cataract and also to deduce various  preventive measures for the modifiable associated factors.
 
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