Central Serous ChorioretinopathyMICROPULSENCT05679180
Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE
A study testing micropulse laser in people with Central Serous Chorioretinopathy, run by University Hospital, Bordeaux.
Trial summary
MICROPULSE study aims to evaluate the efficacy of navigated microsecond laser (nMSL) for chronic central serous chorioretinopathy (CSCR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- micropulse laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2023to 24 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- vision complaints for more than 6 weeks
- subretinal fluid confirmed on OCT
- diagnosis of CSCR confirmed by fluorescein and indocyanine green angiography
- Signed informed consent
- Affiliated or beneficiary of health insurance
Who cannot join
- History of treatment of CSC with other modalities (PDT, eplerenone) in the past 3 months
- Other macular conditions : Age-related Macular Degeneration (AMD), polypoidal vasculopathy, choroidal neovascularization
- Cataract or opacities interfering with acquisition or treatment
- Myopia> 6 diopter
- Visual acuity<20/200
- Treatment with steroids (per-os, inhaled or cutaneous) in the past 3 months
Show all 11Show fewer
- Intra-vitreal injections of anti-VEGF (Vascular Endothelial Growth Factor) or steroids in the past 3 months
- History of allergy to fluorescein or indocyanine
- Inability to agree to participate to the study
- Pregnant or breastfeeding woman
- Patient under legal protection
About this study
MICROPULSE study aims to evaluate the efficacy of navigated microsecond laser (nMSL) for chronic central serous chorioretinopathy (CSCR).
Read the detailed description
Chronic central serous chorioretinopathy (CSCR) is characterized by persistent subretinal fluid (SRF) and extensive outer retinal damage on optical coherence tomography (OCT). In the last years several treatment modalities for chronic CSCR have been investigated. These treatments have included pharmacologic therapy, photodynamic therapy (PDT) and microsecond laser.
PDT is the main treatment for CSCR, especially for chronic CSCR. But the efficacy of PDT is variable and could be associated with various complications such as retinal pigment epithelium (RPE) atrophy. Furthermore other limitations of PDT are unavailability and high cost.
Recently some studies have suggested an efficacy of micropulse laser in chronic CSCR, with stabilization of visual acuity, improvement in retinal sensitivity and without any complications.
The present study aims to evaluate the efficacy of a treatment by guided micropulse laser in the management of chronic CSCR. The efficacity will be evaluated 6 weeks and 3 months after the treatment on anatomical outcomes (central macular thickness in microns)
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- micropulse laser
- Keywords
- retina, photodynamic therapy, micropulse laser, central serous chorioretinopathy
- 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 laserDevice
treatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used.
| Study group | Role | What they receive |
|---|---|---|
| micropulse laser | Experimental | treatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used. Receives: Device: micropulse laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
central macular thickness
central macular thickness measured in microns and determined on spectral-domain OCT
Measured: Month 3
Secondary outcomes (7)
central retinal thickness
central retinal thickness (micrometers)
Measured: Baseline, Month 3
visual acuity
visual acuity via ETDRS (Early Treatment of Diabetic Retinopathy Study) scale. The EDTRS scale is expressed in number of letters read. The scale is logarithmic, i.e. the progression between the 14 lines is geometric (by a factor equal to the cube root of 2). A loss of 3 lines of visual acuity thus corresponds to a doubling of the visual angle.This allows to determine the necessary corrections (sphere, cylinder, axis
Measured: Baseline, Month 3
eye sensitivity
eye sensitivity measured with microperimetry in decibels (dB)
Measured: Baseline, Month 3
presence of sub-retinal fluid
presence of sub-retinal fluid on Spectral-Domain Optical Coherence Tomography (SD-OCT)
Measured: Baseline, Month 3
presence of intraretinal cysts
presence of intraretinal cysts on SD-OCT
Measured: Baseline, Month 3
presence of flat irregular pigment epithelium detachment
presence of flat irregular pigment epithelium detachment (FIPED) on SD-OCT
Measured: Baseline, Month 3
presence of neovascularization
presence of type 1 neovascularization on OCT-angiography
Measured: Baseline, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start11 May 2023
- Primary completion24 May 2023
- Study completion24 May 2023
Why it stopped: Study withdrawn by clinical team
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679180
- Sponsor's protocol ID
- CHUBX 2021/39
- Acronym
- MICROPULSE
- Status last verified
- May 2023
- First submitted
- 28 Dec 2022
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Navigated Microsecond Laser for Chronic Central Serous Chorioretinopathy: MICROPULSE
- ClinicalTrials.gov ID
- NCT05679180
- Acronym / sponsor ID
- MICROPULSE / CHUBX 2021/39
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- retina, photodynamic therapy, micropulse laser, central serous chorioretinopathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn by clinical team
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 10 Jan 2023 (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.
MICROPULSE study aims to evaluate the efficacy of navigated microsecond laser (nMSL) for chronic central serous chorioretinopathy (CSCR).
Detailed description
Chronic central serous chorioretinopathy (CSCR) is characterized by persistent subretinal fluid (SRF) and extensive outer retinal damage on optical coherence tomography (OCT). In the last years several treatment modalities for chronic CSCR have been investigated. These treatments have included pharmacologic therapy, photodynamic therapy (PDT) and microsecond laser.
PDT is the main treatment for CSCR, especially for chronic CSCR. But the efficacy of PDT is variable and could be associated with various complications such as retinal pigment epithelium (RPE) atrophy. Furthermore other limitations of PDT are unavailability and high cost.
Recently some studies have suggested an efficacy of micropulse laser in chronic CSCR, with stabilization of visual acuity, improvement in retinal sensitivity and without any complications.
The present study aims to evaluate the efficacy of a treatment by guided micropulse laser in the management of chronic CSCR. The efficacity will be evaluated 6 weeks and 3 months after the treatment on anatomical outcomes (central macular thickness in microns)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micropulse laser | Experimental | Device: micropulse lasertreatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years and older
- vision complaints for more than 6 weeks
- subretinal fluid confirmed on OCT
- diagnosis of CSCR confirmed by fluorescein and indocyanine green angiography
- Signed informed consent
Key exclusion criteria (11 listed)
- History of treatment of CSC with other modalities (PDT, eplerenone) in the past 3 months
- Other macular conditions : Age-related Macular Degeneration (AMD), polypoidal vasculopathy, choroidal neovascularization
- Cataract or opacities interfering with acquisition or treatment
- Myopia> 6 diopter
- Visual acuity<20/200
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 lasertreatment with confluent spots over the area of focal leak on the earliest phase of fundus fluorescein angiography on Navilas® system using 5% duty cycle with 100 micron spot size with 200 ms envelope. Thirty percent of threshold laser burn power was used. | Device | micropulse laser |
Primary outcome
central macular thickness
Time frame: Month 3
central macular thickness measured in microns and determined on spectral-domain OCT
7 secondary outcomes
central retinal thickness
Time frame: Baseline, Month 3
visual acuity
Time frame: Baseline, Month 3
eye sensitivity
Time frame: Baseline, Month 3
presence of sub-retinal fluid
Time frame: Baseline, Month 3
presence of intraretinal cysts
Time frame: Baseline, Month 3
presence of flat irregular pigment epithelium detachment
Time frame: Baseline, Month 3
presence of neovascularization
Time frame: Baseline, Month 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing micropulse laser in people with Central Serous Chorioretinopathy, run by University Hospital, Bordeaux.
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 6 inclusion and 11 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: withdrawn, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central macular thickness (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2023.