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CTRI Number  CTRI/2025/07/091524 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of Retinochoroidal and Optic Nerve Head Microvascular Alterations Using Optical Coherence Tomography Angiography in South Indian Patients with Thyroid Eye Disease 
Scientific Title of Study   Optical Coherence Tomography Angiography for Retinochoroidal Microvascular and Optic Nerve Head changes in Thyroid Eye Disease seen in Southern Indian Population 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rutuja Naik Nimbalkar 
Designation  DNB Resident First Year 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room No 13, Ground Floor, Department of Orbit and Oculoplasty Surgery, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry.

Pondicherry
PONDICHERRY
605007
India 
Phone  07507772258  
Fax    
Email  rutuja.naiknimbalkar13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayagayathri R 
Designation  Medical Consultant and Head of Orbit and Oculoplasty Surgery  
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room No 13, Ground Floor, Department of Orbit and Oculoplasty Surgery, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry.

Pondicherry
PONDICHERRY
605007
India 
Phone  9843942425  
Fax    
Email  jayagayathri.dr@aravind.org  
 
Details of Contact Person
Public Query  
Name  Jayagayathri R 
Designation  Medical Consultant and Head of Orbit and Oculoplasty Surgery  
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room No 13, Ground Floor, Department of Orbit and Oculoplasty Surgery, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry.

Pondicherry
PONDICHERRY
605007
India 
Phone  9843942425  
Fax    
Email  jayagayathri.dr@aravind.org  
 
Source of Monetary or Material Support  
Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry 605007 
 
Primary Sponsor  
Name  Aravind Eye Hospital, Pondicherry 
Address  Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry - 605007 
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 
Dr Rutuja Naik Nimbalkar  Aravind Eye Hospital, Pondicherry  Room 13, Ground floor, Department Of Orbit and Oculoplasty Surgery, Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry - 605007
Pondicherry
PONDICHERRY 		 7507772258

rutuja.naiknimbalkar13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Aravind Eye Hospital, Pondicherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H052||Exophthalmic conditions, (2) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, (3) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with active and inactive TED irrespective of thyroid status aged from 18 to 70 years. 
 
ExclusionCriteria 
Details  1 Hypertensive retinopathy
2 Diabetic Retinopathy
3 Current pregnancy and breastfeeding
4 Optic neuropathy not related to TED.
5 Psychiatric and cognitive disorders. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate microvascular and structural changes in the retina, choroid, and optic nerve head using OCT and OCTA in patients with Thyroid Eye Disease  At baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate OCT & OCTA findings with the clinical activity & severity of Thyroid Eye Disease.  At baseline. 
To describe the clinical profile of patients with Thyroid Eye Disease in a South Indian population.  At baseline. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   04/08/2025 
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="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 observational study aims to evaluate retinochoroidal and optic nerve head microvascular changes in patients with Thyroid Eye Disease using Optical Coherence Tomography and Optical Coherence Tomography Angiography at Aravind Eye Hospital Pondicherry. Patients aged 18 to 70 with active or inactive Thyroid Eye Disease will undergo detailed ocular evaluation and imaging with Zeiss Cirrus 6000. Parameters such as vessel density perfusion choroidal thickness and foveal avascular zone will be analyzed. The study seeks to determine if OCT and OCTA can serve as a routine non invasive tool for monitoring Thyroid Eye Disease in a Southern Indian population.


 
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