Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: 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.
Sponsors
Hyderabad Eye Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 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.
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.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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the treatment efficacy of NTP over SMTP in the resolution of cCSCTimepoint: 6weeks & 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the best corrected visual acuity (BCVA) change from baseline to month three.Timepoint: 12 Weeks | — |
Countries
India
Contacts
Public ContactDr Umesh Chandra Behera
L V Prasad Eye Institute
Outcome results
None listed