| CTRI Number |
CTRI/2024/08/072314 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A cross sectional study on the Variation in GCC thickness in Indian Patients taking Hydroxychloroquine and its correlation with vessel density |
|
Scientific Title of Study
|
Ganglion Cell Complex thickness in Indian Patients on Hydroxychloroquine and its Correlation with Vessel Density on OCTA – 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 |
Dr Minija CK |
| Designation |
Senior Consultant, Medical Retina and Uvea services, Sankara Eye Hospital, Bangalore |
| Affiliation |
Sankara Eye Hospital, Bengaluru |
| Address |
Room number 26, Department of Medical Retina and uvea services, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bengaluru 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
9480587018 |
| Fax |
|
| Email |
minija_ck@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kelini Nitin Saolapurkar |
| Designation |
Fellow, Medical Retina and Uvea |
| Affiliation |
Sankara Eye Hospital, bengaluru |
| Address |
Room No 26, Department of Medical Retina and Uvea services, Sankara Eye Hospital, Varthur main Road, Kundalahalli Gate, Bengaluru - 560037
Bangalore
KARNATAKA
560037
India |
| Phone |
7760503707 |
| Fax |
|
| Email |
dockelini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kelini Nitin Saolapurkar |
| Designation |
Fellow, Medical Retina and Uvea |
| Affiliation |
Sankara Eye Hospital, bengaluru |
| Address |
Room No 26, Department of Medical Retina and Uvea services, Sankara Eye Hospital, Varthur main road, Kundalahalli Gate, Bengaluru
Bangalore
KARNATAKA
560037
India |
| Phone |
7760503707 |
| Fax |
|
| Email |
dockelini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Varthur main Raod, Kundalahalli Gate, Bengaluru 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital, Bengaluru |
| Address |
Sankara Eye hospital, varthur main road, kundalahalli Gate, bengaluru 560037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kelini Saolapurkar |
Sankara Eye Hospital, Bengaluru |
Room No 26, Department of Medical Retina and Uvea services, Varthur Main Road, Kundalahalli Gate, Bengaluru 560037
Bangalore
KARNATAKA |
7760503707
dockelini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M049||Autoinflammatory syndrome, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patients on HCQ treatment for any rheumatological or dermatological disorder with refractive error less than or equal to +/- 4D and cylinder of less than or equal to -3D with an intraocular pressure measurement of less than 21 mmHg |
|
| ExclusionCriteria |
| Details |
patients diagnosed to have HCQ retinopathy or having systemic diseases like Hypertension, kidney disorder or diabetes mellitus . patients having retinal pigment epithelial abnormalities , or media opacities, glaucoma, preexisting retinal pathology or paracentral scotomas on visual field testing and patients having colour vision defects |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the thickness of Ganglion cell complex at the macula in patients taking HCQ
|
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of GCC Thickness with vessel density changes in SCP & DCP layer in OCTA.
To study correlation of GCC thickness with cumulative dose of HCQ.
|
at baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/09/2024 |
| 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 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
|
Hydroxychloroquine (HCQ) retinopathy is a known side effect of long term administration of HCQ. Predisposing risk factors area daily dose more than 6.5 mg/kg, cumulative dose more than 1000 g, duration of use over 5 years In the initial phase, toxicity is reversible after drug discontinuation However, with current Objective Imaging techniques, irreversible RPE changes have occurred and some degree of visual loss is evident. Therefore, early detection is critical. Increasing evidence exists, of signs of HCQ toxicity in RGC before visual loss occurs before morphological changes occur in the outer retinal layers which are irreversible. GCL complex not studied in Asian patients. While effect of HCQ on vessel density on OCT angiography (OCTA) has been studied, its correlation with GCL thickness has not been studied before. Our study aims to observe the thinning of ganglion cell complex in Asian patients taking HCQ as an early objective sign of toxicity before retinopathy develops.
|