Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy
Primary Purpose
Central Serous Chorioretinopathy
Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Micropulse laser photostimulation
Sponsored by
About this trial
This is an interventional treatment trial for Central Serous Chorioretinopathy
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
Sites / Locations
- Moorfields Eye Hospital CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Minimal Micropulse Arm
Panmacular Micropulse Arm
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 .
Wavelength 810 577 Power 1.7 W 0.425 W DC 5% 5% Spot size 500um 500um Duration 0.3 sec 0.3 sec Number of spots 400-450 400-450
Outcomes
Primary Outcome Measures
Change in Best-Corrected Visual Acuity (BCVA)
BCVA will be measured using ETDRS charts and number of letters will be compared before treatment and during follow-up and at the last visit.
Resolution of Subretinal Fluid
This outcome will be assessed by optical coherence tomography (OCT). Microns of central retinal thickness will be compared before treatment and during follow-up and at the last visit. The presence/absence of subretinal fluid will be recorded.
Secondary Outcome Measures
Visual Field Examination
This will be assessed by Humphry VF analyzer - 10-2 protocol and dB values will be compared before treatment, during follow-up and at the last visit.
Need for Re-treatment
The number of eyes which have nor responded to micropulse treatment and required rescue treatment either intravitreal injection of anti-angiogenic agent or oral eplerenone will be recorded and compared between laser groups.
Full Information
NCT ID
NCT04410861
First Posted
May 27, 2020
Last Updated
June 6, 2020
Sponsor
Moorfields Eye Hospital Centre Abu Dhabi
Collaborators
University of Warmia and Mazury in Olsztyn, University of Gdansk, The Filatov Institute of Eye Diseases and Tissue Therapy, Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04410861
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Moorfields Eye Hospital Centre Abu Dhabi
Collaborators
University of Warmia and Mazury in Olsztyn, University of Gdansk, The Filatov Institute of Eye Diseases and Tissue Therapy, Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
< 6 months. Treatment: Minimal vs. Panmacular (randomized)
> 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:
Visual Acuity as measured by ETRDS chart (number of letters before and after treatment
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:
Visual Field - Humphrey 10-2 protocol (dB value before and after treatment)
Number of treatments required for vision/structure improvement (number of laser sessions)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Serous Chorioretinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minimal Micropulse Arm
Arm Type
Active Comparator
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
.
Arm Title
Panmacular Micropulse Arm
Arm Type
Experimental
Arm Description
Wavelength 810 577 Power 1.7 W 0.425 W DC 5% 5% Spot size 500um 500um Duration 0.3 sec 0.3 sec Number of spots 400-450 400-450
Intervention Type
Procedure
Intervention Name(s)
Micropulse laser photostimulation
Intervention Description
In this treatment invisible, non-damaging laser shots are delivered to the affected area which are believed to lead to absorption of accumulated retinal fluid. Contact lens will be used along with topical anesthesia.Following the procedure eye will be washed with balanced salt solution.
Primary Outcome Measure Information:
Title
Change in Best-Corrected Visual Acuity (BCVA)
Description
BCVA will be measured using ETDRS charts and number of letters will be compared before treatment and during follow-up and at the last visit.
Time Frame
6 months
Title
Resolution of Subretinal Fluid
Description
This outcome will be assessed by optical coherence tomography (OCT). Microns of central retinal thickness will be compared before treatment and during follow-up and at the last visit. The presence/absence of subretinal fluid will be recorded.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Visual Field Examination
Description
This will be assessed by Humphry VF analyzer - 10-2 protocol and dB values will be compared before treatment, during follow-up and at the last visit.
Time Frame
6 months
Title
Need for Re-treatment
Description
The number of eyes which have nor responded to micropulse treatment and required rescue treatment either intravitreal injection of anti-angiogenic agent or oral eplerenone will be recorded and compared between laser groups.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Kozak, M.D., PhD
Phone
+9710266536161
Email
igor.kozak@moorfields.ae
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Luttrull, M.D.
Email
jkluttrull@gmail.com
Facility Information:
Facility Name
Moorfields Eye Hospital Centre
City
Abu Dhabi
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Igor Kozak, M.D., PhD
Phone
066536161
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to patient confidentiality we do not plan to share individual patient data
Citations:
PubMed Identifier
28987614
Citation
Chhablani J, Roh YJ, Jobling AI, Fletcher EL, Lek JJ, Bansal P, Guymer R, Luttrull JK. Restorative retinal laser therapy: Present state and future directions. Surv Ophthalmol. 2018 May-Jun;63(3):307-328. doi: 10.1016/j.survophthal.2017.09.008. Epub 2017 Oct 5.
Results Reference
background
PubMed Identifier
25892934
Citation
Kozak I, Luttrull JK. Modern retinal laser therapy. Saudi J Ophthalmol. 2015 Apr-Jun;29(2):137-46. doi: 10.1016/j.sjopt.2014.09.001. Epub 2014 Sep 28.
Results Reference
background
PubMed Identifier
27841848
Citation
Wood EH, Karth PA, Sanislo SR, Moshfeghi DM, Palanker DV. NONDAMAGING RETINAL LASER THERAPY FOR TREATMENT OF CENTRAL SEROUS CHORIORETINOPATHY: What is the Evidence? Retina. 2017 Jun;37(6):1021-1033. doi: 10.1097/IAE.0000000000001386.
Results Reference
result
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Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy
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