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Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Retinopathy

Primary Purpose

Central Serous Chorioretinopathy, Selective Retina Therapy

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Selective Retina Therapy (SRT)
Sponsored by
University of Kiel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy focused on measuring CSC, SRT

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Anamnestic reduction of visual acuity
  • Atients with best-corrected visual acuity (BCVA) of 20/200 or better
  • Presence of subretinal fluid (SRF) on optical coherence tomography (OCT)
  • Presence of active angiographic (multi)focal leakage in fluorescein angiography (FA) caused by ICSC but not choroidal neovascularisation (CNV) or other diseases
  • Absence of other retinal or ocular diseases (e. g. glaucoma, vessel diseases, vein occlusion or proliferative retinopathy)
  • Absence of cataract or media opacities of a degree which precludes taking retinal photographs and FA's
  • Absence of angle closure glaucoma which precludes pharmacological dilatation of the pupil.

Exclusion Criteria:

  • Patients who received any previous treatment, including PDT or focal cw laser photocoagulation for ICSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination or FA were excluded.
  • Patients receiving exogenous corticosteroid treatment, with systemic diseases such as Cushing's disease or renal diseases, and pregnant patients also were excluded.
  • Informed consent was obtained from all subjects, and the study protocol was approved by the ethics committee of the University of Kiel.

Sites / Locations

  • Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Selective Retinatherapy (SRT)

control group

crossover

Arm Description

Treatment was performed with the SRT-Laser system (Medical Laser Center Lübeck, Germany), which consists of a Q-switched frequency doubled Nd:YLF laser (527nm), operating with a pulse repetition rate of 100 Hz. The pulse duration (full width at half maximum) was 1.7 µs. The laser energy was transmitted via fiber to a Lumenis slitlamp allowing the application of a fixed spot size diameter of 200 µm in air. A Mainster central field contact lens with a magnification of 1.05 was used for all irradiations. Per foot switch, 30 pulses are emitted, the pulse energy was chosen by the physician up to a maximum of 370 µJ. According to the treatment protocol, prior to each treatment 5 test shots with increasing energy were applied adjacent to the vessel arcades, in each patient in order to determine the appropriate pulse energy for treatment by recording the OA-value.

Patients randomized to control group achieve no treatment and are followed up for three months.

After 3 months follow up patients of control group with persistence of disease activity were allocated to crossover group and received either SRT. Crossover group was followed up for further 3 months.

Outcomes

Primary Outcome Measures

Serial changes in ETDRS letterscore

Secondary Outcome Measures

The maximum distance between the RPE and the outer neurosensory retina in the area of Subretinal fluid accumulation

Full Information

First Posted
September 29, 2009
Last Updated
September 29, 2009
Sponsor
University of Kiel
Collaborators
Medical Laser Center Lübeck, Lübeck, Germany, Institute for Medical Informaties and Statistics Kiel, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00987077
Brief Title
Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Retinopathy
Official Title
Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Chorioretinopathy: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Kiel
Collaborators
Medical Laser Center Lübeck, Lübeck, Germany, Institute for Medical Informaties and Statistics Kiel, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of Selective Retina Therapy (SRT) for treating acute idiopathic central serous chorioretinopathy (ICSC). Patients with acute symptomatic ICSC of at least 3 months duration were recruited. The patients were randomized by equal terms to SRT- (Treatment) and control group. After 3 months follow up patients of control group with persistence of disease activity were allocated to crossover group and received either SRT. Crossover group was followed up for further 3 months. The primary outcome measure of the study are the serial changes in Early Treatment of Diabetic Retinopathy Study (ETDRS) letterscore and edema in optical coherence tomography (OCT) at 3 months. Secondary outcome measures included the proportion of eyes with complete absorption of subretinal fluid, leakage in fluorescein angiography and the systemic and ocular complications during the study at 3 months.
Detailed Description
Idiopathic central serous chorioretinopathy (ICSC) is characterized by a serous detachment of the neurosensory retina in the macular region secondary to a focal or retinal pigment epithelial defect. Patients with ICSC, oftentimes young male adults, experience visual disturbances including micropsia, metamorphopsia, central scotoma, reduced visual acuity and loss of contrast sensitivity. Most cases of ICSC are presumed to be self-limiting and usually resolve spontaneously within 3 to 4 months.Nevertheless the duration of the disease is strongly related to the vision prognosis and reattachment within 4 months of onset is considered as a relevant therapeutic target because prolonged detachment is associated with photoreceptor atrophy. The therapeutic effect of focal cw laser photocoagulation has not been fully established. One obvious theory postulates that the beneficial effect of photocoagulation is associated with the establishment of a new barrier of RPE cells which subsequently reintegrate the RPE pump function and the integrity of the RPE as a barrier. Based on this theory, the destruction of tissues surrounding the RPE, in particular Bruch's membrane, the choroid and the photoreceptors, would be an unwanted side effect. On the basis of this consideration Selective Retina Therapy (SRT), which is a innovative laser technology that selectively damages the RPE and spares the neurosensory retina, suggests itself as an ideal treatment for ICSC with focal leakage, especially if the RPE leak is located close to the fovea. It has been proved as safe, and microperimetry has shown that SRT does not cause microscotoma. SRT has already been adopted in the treatment of diverse macular diseases inter alia in patients with ICSC with promising performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy, Selective Retina Therapy
Keywords
CSC, SRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selective Retinatherapy (SRT)
Arm Type
Experimental
Arm Description
Treatment was performed with the SRT-Laser system (Medical Laser Center Lübeck, Germany), which consists of a Q-switched frequency doubled Nd:YLF laser (527nm), operating with a pulse repetition rate of 100 Hz. The pulse duration (full width at half maximum) was 1.7 µs. The laser energy was transmitted via fiber to a Lumenis slitlamp allowing the application of a fixed spot size diameter of 200 µm in air. A Mainster central field contact lens with a magnification of 1.05 was used for all irradiations. Per foot switch, 30 pulses are emitted, the pulse energy was chosen by the physician up to a maximum of 370 µJ. According to the treatment protocol, prior to each treatment 5 test shots with increasing energy were applied adjacent to the vessel arcades, in each patient in order to determine the appropriate pulse energy for treatment by recording the OA-value.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients randomized to control group achieve no treatment and are followed up for three months.
Arm Title
crossover
Arm Type
Experimental
Arm Description
After 3 months follow up patients of control group with persistence of disease activity were allocated to crossover group and received either SRT. Crossover group was followed up for further 3 months.
Intervention Type
Device
Intervention Name(s)
Selective Retina Therapy (SRT)
Other Intervention Name(s)
SRT-Laser system (Medical Laser Center Lübeck, Germany)
Intervention Description
SRT (pulsed double-Q-switched Nd-YLF laser, wavelength 527 nm, t=1.7 µs, energy 100-370 μJ).
Primary Outcome Measure Information:
Title
Serial changes in ETDRS letterscore
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The maximum distance between the RPE and the outer neurosensory retina in the area of Subretinal fluid accumulation
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anamnestic reduction of visual acuity Atients with best-corrected visual acuity (BCVA) of 20/200 or better Presence of subretinal fluid (SRF) on optical coherence tomography (OCT) Presence of active angiographic (multi)focal leakage in fluorescein angiography (FA) caused by ICSC but not choroidal neovascularisation (CNV) or other diseases Absence of other retinal or ocular diseases (e. g. glaucoma, vessel diseases, vein occlusion or proliferative retinopathy) Absence of cataract or media opacities of a degree which precludes taking retinal photographs and FA's Absence of angle closure glaucoma which precludes pharmacological dilatation of the pupil. Exclusion Criteria: Patients who received any previous treatment, including PDT or focal cw laser photocoagulation for ICSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination or FA were excluded. Patients receiving exogenous corticosteroid treatment, with systemic diseases such as Cushing's disease or renal diseases, and pregnant patients also were excluded. Informed consent was obtained from all subjects, and the study protocol was approved by the ethics committee of the University of Kiel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann J Roider, Professor
Organizational Affiliation
Department of Ophthalmology University of Kiel
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ophthalmology
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16758179
Citation
Elsner H, Porksen E, Klatt C, Bunse A, Theisen-Kunde D, Brinkmann R, Birngruber R, Laqua H, Roider J. Selective retina therapy in patients with central serous chorioretinopathy. Graefes Arch Clin Exp Ophthalmol. 2006 Dec;244(12):1638-45. doi: 10.1007/s00417-006-0368-5.
Results Reference
result
PubMed Identifier
16937094
Citation
Klatt C, Elsner H, Porksen E, Brinkmann R, Bunse A, Birngruber R, Roider J. [Selective retina therapy in central serous chorioretinopathy with detachment of the pigmentary epithelium]. Ophthalmologe. 2006 Oct;103(10):850-5. doi: 10.1007/s00347-006-1415-7. German.
Results Reference
result
PubMed Identifier
20554506
Citation
Klatt C, Saeger M, Oppermann T, Porksen E, Treumer F, Hillenkamp J, Fritzer E, Brinkmann R, Birngruber R, Roider J. Selective retina therapy for acute central serous chorioretinopathy. Br J Ophthalmol. 2011 Jan;95(1):83-8. doi: 10.1136/bjo.2009.178327. Epub 2010 Jun 15.
Results Reference
derived
Links:
URL
http://www.mll-luebeck.de/admin/srt.htm
Description
homepage of the Medical Laser Center Lübeck, Lübeck, Germany.

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Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Retinopathy

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