Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina
Primary Purpose
Macular Edema, Central Serous Chorioretinopathy, Retinal Vein Occlusion
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Selective retinal pigment epithelium laser therapy using the R:GEN Laser System
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring selective laser therapy, retinal pigment epithelium, macular edema, diabetic retinopathy, central serous chorioretinopathy, age-related macular degeneration, retinal vein occlusion
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
Sites / Locations
- Department of Ophthalmology, Bern University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Patients receive selective retinal pigment epithelium laser treatment
Outcomes
Primary Outcome Measures
Visual Acuity according to ETDRS protocol
Secondary Outcome Measures
Retinal thickness measured by optical coherence tomography
Leakage of fluorescein in fluorescein angiography
Area of absent fundus autofluorescence
Measured via fundus autofluorescence imaging
Full Information
NCT ID
NCT02088151
First Posted
March 6, 2014
Last Updated
February 7, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT02088151
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Suitable device for laser no longer available
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Central Serous Chorioretinopathy, Retinal Vein Occlusion, Age-related Macular Degeneration, Retinal Neovascularization
Keywords
selective laser therapy, retinal pigment epithelium, macular edema, diabetic retinopathy, central serous chorioretinopathy, age-related macular degeneration, retinal vein occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receive selective retinal pigment epithelium laser treatment
Intervention Type
Device
Intervention Name(s)
Selective retinal pigment epithelium laser therapy using the R:GEN Laser System
Intervention Description
Patients receive selective retinal pigment epithelium laser treatment using the R:GEN Laser System by Lutronic Corporation, Korea.
Primary Outcome Measure Information:
Title
Visual Acuity according to ETDRS protocol
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Retinal thickness measured by optical coherence tomography
Time Frame
6 months
Title
Leakage of fluorescein in fluorescein angiography
Time Frame
6 months
Title
Area of absent fundus autofluorescence
Description
Measured via fundus autofluorescence imaging
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Wolf
Organizational Affiliation
Department of Ophthalmology, Bern University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Ebneter
Organizational Affiliation
Department of Ophthalmology, Bern University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Bern University Hospital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
1463423
Citation
Roider J, Michaud NA, Flotte TJ, Birngruber R. Response of the retinal pigment epithelium to selective photocoagulation. Arch Ophthalmol. 1992 Dec;110(12):1786-92. doi: 10.1001/archopht.1992.01080240126045.
Results Reference
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PubMed Identifier
8378341
Citation
Roider J, Hillenkamp F, Flotte T, Birngruber R. Microphotocoagulation: selective effects of repetitive short laser pulses. Proc Natl Acad Sci U S A. 1993 Sep 15;90(18):8643-7. doi: 10.1073/pnas.90.18.8643.
Results Reference
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PubMed Identifier
9541826
Citation
Roider J, Lindemann C, el-Hifnawi el-S, Laqua H, Birngruber R. Therapeutic range of repetitive nanosecond laser exposures in selective RPE photocoagulation. Graefes Arch Clin Exp Ophthalmol. 1998 Mar;236(3):213-9. doi: 10.1007/s004170050067.
Results Reference
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PubMed Identifier
9951641
Citation
Roider J, Brinkmann R, Wirbelauer C, Birngruber R, Laqua H. Variability of RPE reaction in two cases after selective RPE laser effects in prophylactic treatment of drusen. Graefes Arch Clin Exp Ophthalmol. 1999 Jan;237(1):45-50. doi: 10.1007/s004170050193.
Results Reference
background
PubMed Identifier
10611098
Citation
Roider J, Brinkmann R, Wirbelauer C, Laqua H, Birngruber R. Subthreshold (retinal pigment epithelium) photocoagulation in macular diseases: a pilot study. Br J Ophthalmol. 2000 Jan;84(1):40-7. doi: 10.1136/bjo.84.1.40.
Results Reference
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Selective Retinal Pigment Epithelium Laser Therapy for Macular Disease of the Retina
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