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

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Brief Title

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

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 Description

      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), and visual acuity testing. SRT (R:GEN Laser System by Lutronic Corporation,
      Korea) will be delivered under topical anesthesia. For titration of energy spots will first
      be applied outside the major arcades. Immediately thereafter FA will be performed for
      extrapolation of the laser dose, since the treatment is sub-threshold and laser spots will
      not be visible biomicroscopically. The patient will then be treated at the discretion of the
      ophthalmologist with up to 500 laser burns. One hour after the laser treatment FA will be
      repeated to confirm the treatment effect. Patients will be assessed 1, 3 and 6 months after
      treatment. Pulse duration can be chosen between 200ns and 2μs. The maximum pulse energy will
      be 1mJ. 1-30 pulses will be applied for every laser burn at a frequency of 100Hz.
    


Study Type

Interventional


Primary Outcome

Visual Acuity according to ETDRS protocol

Secondary Outcome

 Retinal thickness measured by optical coherence tomography

Condition

Macular Edema

Intervention

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

Study Arms / Comparison Groups

 Treatment
Description:  Patients receive selective retinal pigment epithelium laser treatment

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

June 2010

Completion Date

December 2020

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Age 18 or over

          -  Written informed consent

          -  Willingness to attend follow-up visits

          -  Central serous chorioretinopathy affecting visual acuity

          -  Macular edema from branch retinal vein occlusion

          -  Macular edema from diabetic microangiopathy

          -  Age-related macular degeneration with confluent soft drusen

          -  Age-related macular degeneration with geographic atrophy

        Exclusion Criteria

          -  Macular ischemia

          -  Retinal hemorrhage impeding retinal laser treatment

          -  Subretinal neovascular membrane

          -  Vitreous hemorrhage

          -  Allergy to fluorescein

          -  Participation in other clinical trials
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Sebastian Wolf, , 

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT02088151

Organization ID

003/10

Secondary IDs

2011-MD-0006

Responsible Party

Sponsor

Study Sponsor

University Hospital Inselspital, Berne


Study Sponsor

Sebastian Wolf, Study Chair, Department of Ophthalmology, Bern University Hospital


Verification Date

October 2019