Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy
This is a prospective, multicentre, sham-controlled, participant- and assessor-masked superiority trial with two parallel treatment arms which aims to investigate the safety and efficacy of subthreshold nanosecond laser (SNL) in a series of adults with sub-retinal fluid secondary to non-resolving central serous chorior
| Condition(s) | Central Serous Chorioretinopathy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a prospective, multicentre, sham-controlled, participant- and assessor-masked superiority trial with two parallel treatment arms which aims to investigate the safety and efficacy of subthreshold nanosecond laser (SNL) in a series of adults with sub-retinal fluid secondary to non-resolving central serous chorioretinopathy (CSCR) by visual and anatomical outcomes. The study population will be individuals with adults (aged 18-70 years inclusive) with non-resolving CSCR (defined as CSCR present for a duration of more than 3 months presenting with either focal or diffuse leakage) who meet all eligibility criteria. 60 subjects total will be enrolled into the study - 40 randomized to receive SNL treatment and 20 to receive sham treatment as per a 2:1 randomization schedule and stratified |
| Who can participate | Inclusion Criteria: 1. Age 18-70 years 2. Both males and females 3. Individuals with non-resolving CSCR as defined by presence of any SRF on OCT for \> 3 months from date of diagnosis to randomisation visit 4. BCVA of 35 to 80 letters (Snellen equivalent of 6/6 to 6/60) in the study eye 5. Ability, willingness and sufficient cognitive awareness to consent to the trial, received randomised SNL treatment or sham procedure, and complete all visits as per the study schedule Exclusion Criteria: 1. A need for extraneous, continuous steroids to control any disease, including both systemic steroids (e.g., for systemic autoimmune conditions) and ocular steroids (e.g., for uveitis), or ongoing anabolic steroid use 2. Any systemic disease that leads to elevated endogenous steroid levels including rai |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Nova Eye Medical Pty Ltd. |
| Locations | East Melbourne, Victoria, Australia; Glen Iris, Victoria, Australia |
| Start date | 2022-10-18 |
| NCT ID | NCT05570591 |
| Official listing | https://clinicaltrials.gov/study/NCT05570591 |