Clinical Trial: Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Selective Retinal Pigment Epithelium Laser Therapy (SRT) for Macular Disease of the Retina
Brief Summary:
Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects.
In this study, patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.
Detailed Summary:
Background
Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). In age-related macular degeneration, regression of drusen has been observed after laser treatment with convention laser or SRT. Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects.
Objective
To assess the efficacy of SRT in patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration. Up to five patients with proliferative diabetic retinopathy can optionally be treated with SRT too.
Methods
At baseline and during follow-up patients will receive a full ophthalmic examination including optical coherence tomography, fundus autofluorescence imaging, fluorescein angiography (FA)
Sponsor: University Hospital Inselspital, Berne
Current Primary Outcome: Visual Acuity according to ETDRS protocol [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Retinal thickness measured by optical coherence tomography [ Time Frame: 6 months ]
- Leakage of fluorescein in fluorescein angiography [ Time Frame: 6 months ]
- Area of absent fundus autofluorescence [ Time Frame: 6 months ]Measured via fundus autofluorescence imaging
Original Secondary Outcome: Same as current
Information By: University Hospital Inselspital, Berne
Dates:
Date Received: March 6, 2014
Date Started: June 2010
Date Completion: June 2018
Last Updated: August 2, 2016
Last Verified: August 2016
