Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Dexamethasone: Intravitreal dexamethasone implant 0.7mg single dose
Control Intervention1: Observation: Sham injection and sham sham laser
Control Intervention2: Laser: Yellow sub-thres
Sponsors
Hyderabad Eye Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults of both genders aged 30 years or more 2. Diagnosis of cCSC confirmed at screening visit by complete ocular examination and multimodal imaging in the study eye 3. Best corrected vision score of 73 to 19 at test distance of 4 meters on ETDRS chart at recruitment (Snellen equivalent 20/40 to 20/400) 4. Decrease in vision primarily secondary to cCSC 5. Willing to sign informed consent form before initiation of any study related procedure.
Exclusion criteria
Exclusion criteria: 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. Non-study eye vision of 7. Aphakia in study eye 8. History of glaucoma in either eye (IOP >24 mmHg) 9. Cataract grade dense enough to affect retinal imaging 10. History of hypersensitivity to fluorescein dye 11. Presence of sub-retinal fluid (SRF) or intra-retinal fluid (IRF) secondary to causes other than CSC 12. Presence of active infectious disease or intra-ocular inflammation, active or suspected periocular infection in either eye at the time of enrolment 13. History of intra-ocular surgery within 3 months in the study eye prior to the randomization 14. Pregnancy induced CSC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate treatment efficacy of DEX over YMPL in resolution of cCSCTimepoint: primary efficacy endpoint at 8 weeks of treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Complete resolution of IRF & SRF as determined on Optical coherence tomography within 2 disc areas of center of the macula 2.Reduction of the central subfield thickness as measured on the OCT. 3.Best corrected visual acuity change with ETDRS like chart at 4 meters 4.Change in leakage patterns on ICGA and fluorescein angiography at 8 and 16 weeks to see if any treatment caused abolition of the leaks 5.Time to resolution and recurrenceTimepoint: within 6 months of treatment initiation | — |
Countries
India
Contacts
Public ContactUmesh Chandra Behera
L V Prasad Eye Institute
Outcome results
None listed