| CTRI Number |
CTRI/2025/10/096126 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Benefits of early laser in CSCR |
|
Scientific Title of Study
|
Visual functions after early laser in Central Serous Chorioretinopathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRitesh Narula |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg,GPR Building, 2nd Floor,Room 207, Suven Clinical Research Department, Banjara Hills, Road No:02, Hyderabad 500034,Telangana, India
Hyderabad
TELANGANA
500034
India |
| Phone |
9711857437 |
| Fax |
|
| Email |
ritesh.narula@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRitesh Narula |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg,GPR Building, 2nd Floor,Room 207, Suven Clinical Research Department, Banjara Hills, Road No:02, Hyderabad 500034,Telangana, India
TELANGANA
500034
India |
| Phone |
9711857437 |
| Fax |
|
| Email |
ritesh.narula@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrRitesh Narula |
| Designation |
consultant, opthalmologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg,GPR Building, 2nd Floor,Room 207, Suven Clinical Research Department, Banjara Hills, Road No:02, Hyderabad 500034,Telangana, India
TELANGANA
500034
India |
| Phone |
9711857437 |
| Fax |
|
| Email |
ritesh.narula@lvpei.org |
|
|
Source of Monetary or Material Support
|
| Hyderabad Eye Research Foundation, L V Prasad Eye Institute, Banjara Hills, Road No:02, Hyderabad 500034, Telangana, India
|
|
|
Primary Sponsor
|
| Name |
Hyderabad Eye Research Foundation, L V Prasad Eye Institute |
| Address |
L V Prasad Eye Institute
L V Prasad Marg,GPR Building, 2nd Floor,Room 207, Suven Clinical Research Department, Banjara Hills, Road No:02, Hyderabad 500034,Telangana, India |
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
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 |
| DrRitesh Narula |
L V Prasad Eye Institute |
L V Prasad Marg,GPR Building, 2nd Floor,Room 207, Suven Clinical Research Department, Banjara Hills, Road No:02, Hyderabad 500034,Telangana, India
Hyderabad
TELANGANA |
9711857437
ritesh.narula@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| L V Prasad Eye Institute, Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H537||Vision sensitivity deficiencies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Focal Laser |
ND-YAG 532nm laser is used to treat area of leakage as identified on dye based angiography
Follow up will be 2 monthly intervals for a period of 6 months |
| Comparator Agent |
NA |
Na |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients presenting with first episode of acute CSCR as diagnosed on OCT with presence of subretinal fluid involving foveal centre with duration of symptoms less than 4 weeks will be included.
|
|
| ExclusionCriteria |
| Details |
1. SRF secondary to cause other than CSCR
2. History suggestive of previous episodes of CSCR (Also by clinical signs or investigations)
3. Presence of CNVM with CSCR
4. Hazy media due to cataracts/ any other cause not allowing detailed imaging
5. Previous history of Anti VEGF/ Laser photocoagulation
6. Presence of cystic macular edema or subretinal exudates associated ocular comorbidities
7. Any allergy/ systemic contraindication to use of FFA/ICGA dyes or laser.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Effect of laser on higher-order visual functions following fluid resolution.
Key vision metrics analysed:
2.BCVA
3.Contrast Sensitivity
Colour Vision
4.Metamorphopsia
5.Aniseikonia
|
2, 4 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients achieving fluid resolution in each arm.
Number of crossovers (patients transitioning from observation to laser).
ICGA findings for non-resolving CSCR cases.
Comparison of change in OCT parameters to microperimetry changes
|
2, 4 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="1"
Days="1" |
|
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
|
•CSCR is a retinal disorder caused by choroidal vascular abnormalities, resulting in subretinal fluid (SRF) accumulation and disturbances in retinal pigment epithelium (RPE) function. •Patients experience significant impairment in qualitative visual functions—such as contrast sensitivity, colour vision, and metamorphopsia—that can persist even after SRF resolution. •Laser photocoagulation accelerates SRF resolution, but its role in preserving visual functions remains unclear. •This study aims to investigate whether early laser photocoagulation in acute CSCR can mitigate the loss of qualitative visual functions compared to conventional observation. |