| CTRI Number |
CTRI/2026/01/100480 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Corneal changes in Thyroid eye disease patients |
|
Scientific Title of Study
|
Analysing corneal structural changes in patients with thyroid eye disease using Corneal topography and Specular microscopy A comparative Cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sruthi P J |
| Designation |
Doctor |
| Affiliation |
Aravind Eye Hospital,Pondicherry |
| Address |
Aravind Eye Hospital , Orbit department Room number 13,Cuddalore Main Road,Thavalakuppam,Pondicherry, PIN 605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
04132619200 |
| Fax |
|
| Email |
sruthi.prabhakaran@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dayakar Yadalla |
| Designation |
Doctor |
| Affiliation |
Aravind Eye Hospital,Pondicherry |
| Address |
Aravind Eye Hospital , Orbit department ,Room number 13,Cuddalore Main Road,Thavalakuppam,Pondicherry, PIN 605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
0413-2619200 |
| Fax |
|
| Email |
dayakar.dr@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Sruthi P J |
| Designation |
Doctor |
| Affiliation |
Aravind Eye Hospital,Pondicherry |
| Address |
Aravind Eye Hospital , Orbit department, Room number 13,Cuddalore Main Road,Thavalakuppam,Pondicherry, PIN 605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
0413-2619200 |
| Fax |
|
| Email |
sruthi.prabhakaran@aravind.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital ,Pondicherry |
| Address |
Aravind Eye Hospital,Cuddalore Main Road,Thavalakuppam,Pondicherry |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sruthi P J |
Aravind Eye Hospital |
Orbit department Room number 13
Pondicherry
PONDICHERRY |
04132619200
sruthi.prabhakaran@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H187||Other and unspecified corneal deformities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Active thyroid eye disease,CAS Score more than or equal to 3
2.Inactive thyroid eye disease,CAS Score less than or equal to 3 |
|
| ExclusionCriteria |
| Details |
1.Proptosis with causes other than thyroid eye disease
2.Deformity of cranium or asymmetric orbital size
3.Previous orbital surgery including orbital decompression or radiotherapy to orbital,keratoplasty
4.Patients on systemic steroids
5.Contact lens wear
6.Corneal endothelial dystrophy
7.Patients with topical medication use(artificial tears)
8.Patients with systemic disease-uncontrolled diabetes mellitus,sjogrens syndrome,rheumatoid arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative indices like corneal topography, coefficient of variance, hexagonality may serve as markers for disease activity and response to treatment |
1day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determining the prevalence of astigmatism & corneal surface asymmetry can help in surgical planning & help in preventing complications & can assessment for suitability of refractive procedures |
1day |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
20/01/2026 |
| 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="0"
Months="10"
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
|
The study is to evaluate corneal topographical and endothelial changes observed in patients with thyroid eye disease and to assess their relationship with disease severity, also to determine the prevalence of astigmatism and corneal surface asymmetry in patients with thyroid eye disease. |