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

Central Serous Chorioretinopathy Clinical Trial

Official title:

Selective Retina Therapy (SRT) in Patients With Idiopathic Central Serous Chorioretinopathy: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987077
• Other study ID #: SRT_CSC_Kiel
• Status: Completed
• Phase: Phase 2
• First received: September 29, 2009
• Last updated: September 29, 2009
• Start date: April 2007
• Est. completion date: January 2009

Study information

• Verified date: September 2009
• Source: University of Kiel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy
• Selective Retina Therapy

Intervention

Device:
• Selective Retina Therapy (SRT)
SRT (pulsed double-Q-switched Nd-YLF laser, wavelength 527 nm, t=1.7 µs, energy 100-370 µJ).

Locations

Country	Name	City	State
Germany	Department of Ophthalmology	Kiel	Schleswig-Holstein

Sponsors (3)

Lead Sponsor	Collaborator
University of Kiel	Institute for Medical Informaties and Statistics Kiel, Germany, Medical Laser Center Lübeck, Lübeck, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Elsner H, Pörksen 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. — View Citation

Klatt C, Elsner H, Pörksen 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. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serial changes in ETDRS letterscore		3 months	No
Secondary	The maximum distance between the RPE and the outer neurosensory retina in the area of Subretinal fluid accumulation		3 months	No