| CTRI Number |
CTRI/2025/12/099813 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Types of Laser Treatment in Patients with Chronic Central Serous Chorioretinopathy |
|
Scientific Title of Study
|
Targeted subthreshold micropulse laser (SMPL) versus non-targeted pattern (NTP) laser in chronic central serous chorioretinopathy (ViiV study) |
| Trial Acronym |
ViiV Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-245-BHR-18 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Chandra Behera |
| Designation |
Consultant Ophthalmologist, Retina & Vitreous Services |
| Affiliation |
L V Prasad Eye Institute |
| Address |
Retina and Vitreous Services Department,
L V Prasad Eye Institute, MTC Campus, Patia, Bhubaneswar, Pin- 751024, Odisha, India
Khordha
ORISSA
751024
India |
| Phone |
9853011697 |
| Fax |
|
| Email |
umesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh Chandra Behera |
| Designation |
Consultant Ophthalmologist, Retina & Vitreous Services |
| Affiliation |
L V Prasad Eye Institute |
| Address |
Retina and Vitreous Services Department,
L V Prasad Eye Institute, MTC Campus, Patia, Bhubaneswar, Pin- 751024, Odisha, India
ORISSA
751024
India |
| Phone |
9853011697 |
| Fax |
|
| Email |
umesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh Chandra Behera |
| Designation |
Consultant Ophthalmologist, Retina & Vitreous Services |
| Affiliation |
L V Prasad Eye Institute |
| Address |
Retina and Vitreous Services Department,
L V Prasad Eye Institute, MTC Campus, Patia, Bhubaneswar, Pin- 751024, Odisha, India
ORISSA
751024
India |
| Phone |
9853011697 |
| Fax |
|
| Email |
umesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hyderabad Eye Research Foundation |
| Address |
L V Prasad Eye Institute, MTC Campus, Patia, Bhubaneswar, Pin- 751024, Odisha, in
Khordha
ORISSA
751024
India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Umesh Chandra Behera |
L V Prasad Eye Institute |
Retina and Vitreous Services Department,
L V Prasad Eye Institute, MTC Campus, Patia, Bhubaneswar, Pin- 751024, Odisha, India
Khordha
ORISSA |
9853011697
umesh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, L V Prasad Eye Institute, MTC Campus, Patia, Bhubaneswar, Pin- 751024, Odisha, India |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non- targeted pattern laser (NTP) yellow 577nm |
Participants randomised to this group will receive a single diode laser treatment that does not rely on fluorescein angiography guidance.
Follow-up will be for up to 12 weeks, accordingly: Visit 1 (Screening), Visit 2 (Randomisation), Visit 3 (At 6 weeks), and Visit 4 (At 12 weeks). Visits 1 and 2 may occur on the same day. |
| Comparator Agent |
Standard subthreshold micropulse laser (SMPL) |
Participants randomised to this group will receive a single diode Standard subthreshold micropulse laser (SMPL) guided by imaging.
Follow-up will be for up to 12 weeks, accordingly: Visit 1 (Screening), Visit 2 (Randomisation), Visit 3 (At 6 weeks), and Visit 4 (At 12 weeks). Visits 1 and 2 may occur on the same day. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults of both genders aged 30 to 60 years of both gender.
2.Diagnosis of cCSC confirmed at screening visit by complete ocular examination and multimodal imaging in the study eye using the following criteria.
•Non resolving and recurrent CSC represented by subretinal fluid (SRF) involving the macular center with or without the presence of pigment epithelial detachment (PED).
•A known history of waxing and waning CSC of more than 6 months.
•Non resolving and recurrent CSC with at least a single, multifocal, diffuse or poorly defined leak on fluorescein angiography (FA). Presence of window defects on FA.
•Chronic disease on multimodal imaging defined as presence of gravitational tracts, RPE atrophy, gliosis, scarring on colour fundus photo and autofluorescence imaging.
•Sub-foveal choroidal thickness (SFCT) of greater than equal to 300microns, defined as the distance from the RPE line to the hyperreflective line behind the large vessel layers of the choroid, presumed to be the choroid and sclera interface, manually measured in the horizontal section, passing directly through the fovea.
3.Best corrected vision score of 73 to 19 at test distance of 4 meters on ETDRS chart at recruitment (Snellen equivalent 20 by 40 to 20 by 400)
4.Decrease in vision primarily secondary to cCSC
5.Willing to sign an informed consent form before initiation of any study related procedure.
|
|
| ExclusionCriteria |
| Details |
1.Patients not able to comply with the study or follow-up procedures
2.Laser/ PDT treatment for CSC within 3 months of enrolment
3.Use of corticosteroids in all forms within 3 months of enrolment
4.Pharmacological treatment (eplerenone) for CSC within a month of enrolment
5.Eyes with choroidal neovascularization demonstrable on multimodal imaging (OCTA/FA/ICGA)
6.Presence of intraretinal fluid (IRF), intraretinal cysts (IRC), and retinal schisis.
7.Non-study eye vision of less than 20/200,
8.Aphakia in study eye
9.History of glaucoma in either eye (IOP greater than 24 mmHg)
10.Cataract grade that may affect retinal imaging
11.History of hypersensitivity to fluorescein dye
12.Presence of sub-retinal fluid (SRF) or intra-retinal fluid (IRF) secondary to causes other than CSC
13.Presence of active infectious disease or intra-ocular inflammation, active or suspected periocular infection in either eye at the time of enrolment
14.History of intra-ocular surgery within 3 months in the study eye before the randomization
15.Pregnancy induced CSC.
16.Any advanced, severe or unstable disease or its treatment at the time of enrolment that could interfere with primary and secondary outcome evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at unique risk.
17.Ocular disorders in the study eye at the time of enrolment that may confound the interpretation of study results, compromise visual acuity, or require medical or surgical intervention during the 3-month study period (including retinal detachment, cataract and pre-retinal membrane of the macula)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate the treatment efficacy of NTP over SMTP in the resolution of cCSC |
6weeks & 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the best corrected visual acuity (BCVA) change from baseline to month three. |
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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)
|
11/01/2026 |
| 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="2"
Months="0"
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
|
All eligible
subjects with non-resolving fluid in chronic CSC will be randomised into one of
the arms. A single episode of laser will be delivered on a diode laser
platform. The fluid resolution will be assessed in two follow-up visits at
6-week intervals.
The screening period (Visit 1) may last
up to 14 days, during which, after signing the Informed consent, several
procedures will be performed to assess eligibility (patient and study eye). For
study eye eligibility, refraction, axial length, BCVA, intraocular pressure,
anterior biomicroscopy and ophthalmoscopy will be performed; also OCT, FA, AF,
OCTA and ICGA images will be taken. For patient eligibility medical history and
concomitant medication information will be completed.
At Visit 2 (Day 1) if eligibility
criteria are met, (Visit 1 and Visit 2 can be performed on the same day)
patients will be randomised into two treatment groups (ratio 1:1). The
randomised subjects (Group I - NTP) and Group II - SMPL) will receive the study
intervention by the investigator.
Patients will return (Visit 3) to the clinical
center at 6 weeks (Day 42 ± 7 days) and 12 weeks (Day 84 ± 7 days) to undergo
efficacy assessments and imaging. At each visit, patients will be examined by
the evaluating investigator, consisting of visual acuity measurements,
ophthalmic examinations and evaluation of adverse events like worsening CSC and
visual field defects. |