Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Retinopathy
NCT ID: NCT00987077
Last Updated: 2009-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2007-04-30
2009-01-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Selective Retinatherapy (SRT)
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.
Selective Retina Therapy (SRT)
SRT (pulsed double-Q-switched Nd-YLF laser, wavelength 527 nm, t=1.7 µs, energy 100-370 μJ).
control group
Patients randomized to control group achieve no treatment and are followed up for three months.
No interventions assigned to this group
crossover
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.
Selective Retina Therapy (SRT)
SRT (pulsed double-Q-switched Nd-YLF laser, wavelength 527 nm, t=1.7 µs, energy 100-370 μJ).
Interventions
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Selective Retina Therapy (SRT)
SRT (pulsed double-Q-switched Nd-YLF laser, wavelength 527 nm, t=1.7 µs, energy 100-370 μJ).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
ALL
No
Sponsors
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Medical Laser Center Lübeck, Lübeck, Germany
UNKNOWN
Institute for Medical Informaties and Statistics Kiel, Germany
UNKNOWN
University of Kiel
OTHER
Principal Investigators
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Johann J Roider, Professor
Role: STUDY_DIRECTOR
Department of Ophthalmology University of Kiel
Locations
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Department of Ophthalmology
Kiel, Schleswig-Holstein, Germany
Countries
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References
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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.
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.
Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
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.
Related Links
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homepage of the Medical Laser Center Lübeck, Lübeck, Germany.
Other Identifiers
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SRT_CSC_Kiel
Identifier Type: -
Identifier Source: org_study_id