Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy

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Brief Title

Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy

Official Title

Comparison of Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy

Brief Summary

      Central serous retinopathy is a disease of poorly understood etiology characterized by
      accumulation of subretinal fluid and leading to significant decrease in vision. Micropulse
      laser therapy has been successfully used in the treatment of CSR of both acute and chronic
      types (1). In this treatment invisible, non-damaging laser shots are delivered to the
      affected area which are believed to lead to absorption of accumulated fluid. The mechanism of
      fluid resorption is unclear. There are several treatment protocols in place (2, 3). Most
      commonly reported are minimal protocol and so-called panmacular protocol. However, there is
      no comparative study between them assessing their clinical efficacy.

      The purpose of this trial is to compare treatment efficacy in central serous
      chorioretinopathy (CSR) using two laser parameter settings. Those will include minimal and
      panmacular protocols. Two wavelengths will be used 577nm and 810 nm for which the rest of the
      parameters will be defined in order to produce sublethal photostimulation. Structural and
      functional outcomes will be compared before and after treatment as well as measures such as
      number of repeat treatments or need for rescue treatment. We aim to show which of the laser
      arms will lead to better clinical outcomes.
    

Detailed Description

      Study Design:

      This is a comparative, prospective, interventional, multicenter, randomized study of
      micropulse laser treatment of central serous chorioretinopathy with 2 treatment arms:

        1. < 6 months. Treatment: Minimal vs. Panmacular (randomized)

        2. > 6 months. Treatment: Panmacular only

      Treatment arms - description of laser settings:

      For "Minimal / PLACE" treatment (Mainster contact lens with magnification of 1.05x):

      Wavelength 810nm or 577nm, Power 0.75 Watt for 810 nm or 0.15 Watt for 577 nm, Duty Cycle 5%
      for both wavelenths, Spot size 125um for 810 nm and 100um for 577 nm, Duration 0.3 sec 0.3
      sec for both wavelenths, Number of spots 100-120 for both wavelenths

      For "Panmacular" treatment (Mainster lens mag 1.05x):

      Wavelength 810nm or 577nm, Power 1.70 Watt for 810 nm or 0.425 Watt for 577 nm, Duty Cycle 5%
      for both wavelenths, Spot size 50um for both wavelengths, Duration 0.3 sec 0.3 sec for both
      wavelenths, Number of spots 400-450 for both wavelenths

      All treatments will be performed following informed consent and under topical anesthesia
      using eyedrops 3x before procedure in the treatment eye(s). Follow-up will be every 6 weeks
      with final one in 6 months. Each follow-up visit will include visual acuity measurement,
      intraocular pressure, slit-lamp examination, VF and OCT examinations.

      Primary Endpoints:

        1. Visual Acuity as measured by ETRDS chart (number of letters before and after treatment

        2. Complete subretinal fluid resolution as assessed by OCT examination (microns of central
           retinal thickness before and after treatment; presence/absence of subretinal fluid)

      Secondary Endpoints:

        1. Visual Field - Humphrey 10-2 protocol (dB value before and after treatment)

        2. Number of treatments required for vision/structure improvement (number of laser
           sessions)

        3. Rescue rate - number of eyes requiring intravitreal injection of anti-angiogenic agents
           or oral eplerenone

      Risks: Non-response to therapy in which case alternative rescue treatments (intravitreal
      injection or oral eplerenone) will be offered to patient.

      Benefits: Patient participating in the study will receive standard of care. Participation
      will be entirely voluntary and in case of withdrawing from the study patient will be
      receiving alternative approved methods of treatment.
    


Study Type

Interventional


Primary Outcome

Change in Best-Corrected Visual Acuity (BCVA)

Secondary Outcome

 Visual Field Examination

Condition

Central Serous Chorioretinopathy

Intervention

Micropulse laser photostimulation

Study Arms / Comparison Groups

 Minimal Micropulse Arm
Description:  Wavelength 810 577 Power 0.75 W 0.15 W DC 5% 5% Spot size 125um 100um Duration 0.3 sec 0.3 sec Number of spots 100-120 100-120
.

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

Procedure

Estimated Enrollment

40

Start Date

June 1, 2020

Completion Date

January 1, 2022

Primary Completion Date

June 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  CSR diagnosed < 6 months ago Willingness to undergo micropulse laser treatment and
             keep follow-up visits

        Exclusion Criteria:

          -  High myopia Other significant macular disease, other treatment for CSR Pregnancy
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

, +9710266536161, [email protected]

Location Countries

United Arab Emirates

Location Countries

United Arab Emirates

Administrative Informations


NCT ID

NCT04410861

Organization ID

MoorfieldsEyeAbuDhabi


Responsible Party

Principal Investigator

Study Sponsor

Moorfields Eye Hospital Centre Abu Dhabi

Collaborators

 University of Warmia and Mazury in Olsztyn

Study Sponsor

, , 


Verification Date

June 2020