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Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina

NCT02088151 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-09

No results posted yet for this study

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.

Conditions

  • Macular Edema
  • Central Serous Chorioretinopathy
  • Retinal Vein Occlusion
  • Age-related Macular Degeneration
  • Retinal Neovascularization

Interventions

DEVICE

Selective retinal pigment epithelium laser therapy using the R:GEN Laser System

Patients receive selective retinal pigment epithelium laser treatment using the R:GEN Laser System by Lutronic Corporation, Korea.

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Sebastian Wolf · Department of Ophthalmology, Bern University Hospital

  • Andreas Ebneter · Department of Ophthalmology, Bern University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2022-02-01
Completion
2022-02-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088151 on ClinicalTrials.gov