| CTRI Number |
CTRI/2020/12/029931 [Registered on: 18/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative study between normals and patients with problems at the back of their eye and its relationship with stress |
|
Scientific Title of Study
|
Comparison of Optical Coherence Tomography features and Anxiety Scores in patients with Central Serous Chorioretinopathy versus Controls. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AEH/PDY/EC/THESIS/66/2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saloni Joshi |
| Designation |
Primary DNB resident |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room no 22
Vitreoretina Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9673882893 |
| Fax |
|
| Email |
joshi.saloni@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manavi D Sindal |
| Designation |
Head of Department Vitreoretina Services |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room no 22
Vitreoretina Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9884081417 |
| Fax |
|
| Email |
manavi@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manavi D Sindal |
| Designation |
Head of Department Vitreoretina Services |
| Affiliation |
Aravind Eye Hospital Pondicherry |
| Address |
Room no 22
Vitreoretina Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9884081417 |
| Fax |
|
| Email |
manavi@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital Pondicherry |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Pondicherry |
| Address |
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry 605007
|
| 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 |
| Dr Saloni Joshi |
Aravind Eye Hospital |
Room number 22
Vitreoretina Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry 605007
Pondicherry
PONDICHERRY |
9673882893
joshi.saloni@aravind.org |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H32||Chorioretinal disorders in diseases classified elsewhere, (2) ICD-10 Condition: H579||Unspecified disorder of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Central Serous Chorioretinopathy Patients |
Treatment naïve cases with first episode of CSCR presenting to the Retina Services at Aravind Eye Hospital Pondicherry |
| Comparator Agent |
Controls |
Controls who are age and gender matched visiting Aravind eye hospital for eye exam
Nil systemic illness
Anterior segment no vision threatening pathology Cataract Nil/LC/NS1 or PCIOL with no PCO
Having a normal fundus
Refractive error within +2 D to – 2 D spherical equivalent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Group A:
Treatment naïve cases with first episode of CSCR presenting to the Retina Services at Aravind Eye Hospital Pondicherry
Patients willing to give informed written consent
Presenting within the age group of 18-55 years
Group B:
Controls who are age and gender matched visiting Aravind eye hospital for eye exam
Nil systemic illness
Anterior segment – no vision threatening pathology. Cataract Nil/LC/NS1 or PCIOL with no PCO
Having a normal fundus
Refractive error within +2 D to – 2 D spherical equivalent
Patients willing to give informed written consent |
|
| ExclusionCriteria |
| Details |
Patients with any other ocular pathology.
Children and adolescents below 18 years
Adults above 55 years.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
In CSCR the pachychoroid spectrum maybe more as compared to controls
The stress and anxiety risk factors are also maybe more in CSCR compared to normal controls
The OCT findings will be well defined and confirm the characteristics of pachychoroid disease spectrum
|
At Baseline (Day 0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
25/12/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Study Not yet Started |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM1.
To compare the choroidal
thickness on Enhanced Depth Imaging Optical Coherence Tomography (EDI-OCT) and
Anxiety scores between patients with CSCR versus normal controls.
EXPECTED
OUTCOME: 1. In
CSCR, the pachychoroid spectrum maybe more as compared to controls. 2. The
stress and anxiety risk factors are also maybe more in CSCR, compared to normal
controls.
3. The
OCT findings will be well defined and confirm the characteristics of
pachychoroid disease spectrum.
|