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

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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

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Serial changes in ETDRS letterscore

Secondary Outcome

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

Condition

Central Serous Chorioretinopathy

Intervention

Selective Retina Therapy (SRT)

Study Arms / Comparison Groups

 Selective Retinatherapy (SRT)
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.

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

30

Start Date

April 2007

Completion Date

January 2009

Primary Completion Date

January 2009

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Johann J Roider, Professor, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00987077

Organization ID

SRT_CSC_Kiel



Study Sponsor

University of Kiel

Collaborators

 Medical Laser Center Lübeck, Lübeck, Germany

Study Sponsor

Johann J Roider, Professor, Study Director, Department of Ophthalmology University of Kiel


Verification Date

September 2009