Central Serous ChorioretinopathyNCT04410861
Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy
A study testing Micropulse laser photostimulation in people with Central Serous Chorioretinopathy, run by Moorfields Eye Hospital Centre Abu Dhabi at 1 site in United Arab Emirates.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Micropulse laser photostimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jun 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- CSR diagnosed < 6 months ago Willingness to undergo micropulse laser treatment and keep follow-up visits
Who cannot join
- High myopia Other significant macular disease, other treatment for CSR Pregnancy
Trial locations and contacts
1 site in 1 country.
Jeffrey Luttrull, M.D. contact
United Arab Emirates1 site, 1 recruiting
- Recruiting
Moorfields Eye Hospital Centre
Abu Dhabi
Igor Kozak, M.D., PhD, 066536161
About this study
Official title: Comparison of Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy
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.
Read the 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.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Micropulse laser photostimulation
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropulse laser photostimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Micropulse Arm | Active comparator | 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
. Receives: Procedure: Micropulse laser photostimulation |
| Panmacular Micropulse Arm | Experimental | 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 Receives: Procedure: Micropulse laser photostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital Centre Abu Dhabi
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn, University of Gdansk, The Filatov Institute of Eye Diseases and Tissue Therapy, Chang Gung Memorial Hospital
- Responsible party
- Principal investigator, Igor Kozak, Moorfields Eye Hospital Centre Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04410861
- Sponsor's protocol ID
- MoorfieldsEyeAbuDhabi
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient confidentiality we do not plan to share individual patient data
Publications
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.
PubMed 28987614Kozak 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.
PubMed 25892934Wood 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.
PubMed 27841848
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Panmacular Versus Minimal Micropulse Laser Therapy in Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT04410861
- Acronym / sponsor ID
- MoorfieldsEyeAbuDhabi
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Moorfields Eye Hospital Centre Abu DhabiUniversity, hospital or other
- Collaborators
- University of Warmia and Mazury in Olsztyn, University of Gdansk, The Filatov Institute of Eye Diseases and Tissue Therapy, Chang Gung Memorial Hospital
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Micropulse Arm | Active comparator | Procedure: Micropulse laser photostimulationWavelength 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 . |
| Panmacular Micropulse Arm | Experimental | Procedure: Micropulse laser photostimulationWavelength 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- CSR diagnosed < 6 months ago Willingness to undergo micropulse laser treatment and keep follow-up visits
Key exclusion criteria (1 listed)
- High myopia Other significant macular disease, other treatment for CSR Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micropulse laser photostimulationIn 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. | Procedure or surgery | Minimal Micropulse Arm, Panmacular Micropulse Arm |
Primary outcome
Change in Best-Corrected Visual Acuity (BCVA)
Time frame: 6 months
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
Time frame: 6 months
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.
2 secondary outcomes
Visual Field Examination
Time frame: 6 months
Need for Re-treatment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 28987614Chhablani 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.
- Background: PubMed 25892934Kozak 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 publication: PubMed 27841848Wood 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.
- Individual participant dataSharing planned: No. Due to patient confidentiality we do not plan to share individual patient data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Luttrull, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulse laser photostimulation in people with Central Serous Chorioretinopathy, run by Moorfields Eye Hospital Centre Abu Dhabi at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Kozak, M.D., PhD (+9710266536161, igor.kozak@moorfields.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-Corrected Visual Acuity (BCVA) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04410861, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.