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CTRI Number  CTRI/2025/12/098801 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Diabetes-Related Eye Disease Impacts Corneal Shape and Thickness 
Scientific Title of Study   A study on Central Corneal Thickness and Keratometric Parameters and their association in Diabetic Retinopathy 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rekhi Kriti Prithie Madhuri  
Designation  Postgraduate  
Affiliation  Alluri Sitarama Raju Academy of Medical Sciences Eluru  
Address  Alluri Sitarama Raju Academy of Medical Sciences, Malkapuram, Eluru, West Godavari, Andhra Pradesh

West Godavari
ANDHRA PRADESH
534005
India 
Phone  8754552431  
Fax    
Email  kritirekhi30@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr. M S S Keerthi 
Designation  Postgraduate  
Affiliation  Alluri Sitarama Raju Academy of Medical Sciences Eluru  
Address  Alluri Sitarama Raju Academy of Medical Sciences, Malkapuram, Eluru, West Godavari, Andhra Pradesh

West Godavari
ANDHRA PRADESH
534005
India 
Phone  9676965664  
Fax    
Email  sumakeerthi.dr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rekhi Kriti Prithie Madhuri  
Designation  Postgraduate  
Affiliation  Alluri Sitarama Raju Academy of Medical Sciences Eluru  
Address  Alluri Sitarama Raju Academy of Medical Sciences, Malkapuram, Eluru, West Godavari, Andhra Pradesh

West Godavari
ANDHRA PRADESH
534005
India 
Phone  8754552431  
Fax    
Email  kritirekhi30@gmail.com   
 
Source of Monetary or Material Support  
OPD no. 115, Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Malkapuram, Eluru, Andhra Pradesh 534005 
 
Primary Sponsor  
Name  Dr Rekhi Kriti Prithie Madhuri  
Address  OPD no. 115, Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Malkapuram, Eluru, Andhra Pradesh 534005 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Alluri Sitarama Raju Academy of Medical Sciences   Alluri Sitarama Raju Academy of Medical Sciences, Malkapuram, Eluru, Andhra Pradesh 534005 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rekhi Kriti Prithie Madhuri   Dept. of Ophthalmology, ASRAM, Eluru   OPD no. 115, Department of Ophthalmology, Alluri Sitarama Raju Academy of Medical Sciences, Malkapuram, Eluru, Andhra Pradesh 534005
West Godavari
ANDHRA PRADESH 		 8754552431

kritirekhi30@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ASRAMS BHR Ethics Committee  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  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diagnosed cases of type 2 DM - according to ADA criteria
Consent to participate
 
 
ExclusionCriteria 
Details  Patients who have received laser and intravitreal injection treatment for diabetic retinopathy.
History of ocular trauma/surgery
Corneal dystrophies/degenerations.
Contact lens users.
Glaucoma, high refractive error, and systemic diseases affecting the cornea.
Dense cataract.
Anemia and other systemic diseases/disorders affecting HbA1C levels 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Positive correlation between CCT and DR severity.  0 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   15/01/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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 cross-sectional observational study, conducted at ASRAM Medical College, which aims to evaluate the relationship between central corneal thickness (CCT), keratometric parameters (K1, K2), and the severity of diabetic retinopathy (DR) in patients with type 2 diabetes mellitus. A total of 160 participants (80 with DR and 80 without DR) aged 35–70 years will undergo comprehensive ophthalmic examinations, including anterior segment OCT for CCT measurement, autokeratometry, and fundus photography for DR grading based on the ETDRS classification, along with HbA1c assessment for glycemic control. Statistical analysis using Pearson’s correlation and independent t-tests will identify associations between corneal parameters, DR severity, and HbA1c levels. The study seeks to determine whether corneal changes can serve as early, non-invasive indicators of diabetic eye disease and metabolic control. 
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