Central Serous ChoroidopathyPhase 2/3NCT02735213
Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
A Phase 2/3 study testing 577-MPL and TLT in people with Central Serous Choroidopathy, run by The Eye Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Serous Choroidopathy
- What is being tested?
- 577-MPL and TLT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Sep 2017
- Phase
- Phase 2/3
- 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
- Patients with CSC；
- age>=18 years old;
- Duration is less than 6 months；
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT), and CRT>=250um;
- active leakage located at ring 2 and ring 3 (ETDRS rings) on fluorescein angiography (FA).
Who cannot join
- Patients with no case of CSC；
- Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration；
- Patients with prior retinal treatment less than 3 months；
- Inability to obtain photographs or to perform FA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy.
Read the detailed description
Central serous chorioretinopathy (CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity. Some studies have shown that traditional laser treatment (TLT) is effective on CSC, although accompanied with side-effects, such as scar. Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between TLT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus traditional laser treatment in central serous chorioretinopathy. It is a noninferiority study. The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity.This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment. The primary outcome measures is the change of BCVA in 12 week.
- Conditions
- Central Serous Choroidopathy
- Being tested
- 577-MPL, TLT
- Keywords
- Central Serous Choroidopathy, Micropulse Laser Treatment, Traditional laser Treatment, optical coherence tomography
- 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.
577-MPLDevice
9 spots multispot micropulse mode(without spacing between the spots),160 um spot size, 0.2 second duration, 5% duty cycle(ON time 0.1ms + OFF time 1.9ms), and 250~400 milliWatts of power(50% threshold power),150~200 spots, the laser area is the corresponding leakage on mid-phase FA and around leakage.
TLTDevice
contimuous wave,100um spot size, 0.05 seconds duration, 55~60 milliwatts of power, 18~27 spots,the laser area is the corresponding leakage on mid-phase FA.
| Study group | Role | What they receive |
|---|---|---|
| 577-MPL | Experimental | 577nm subthreshold micropulse laser(577-MPL) will be performed on the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein. Multiple laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um. Receives: Device: 577-MPL |
| TLT | Active comparator | Traditional laser will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Traditional laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um. Receives: Device: TLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Best Corrected Visual Acuity (BCVA)
ETDRS BCVA
Measured: 12 week
Secondary outcomes (4)
the number of patients without any subretinal fluid (SRF)
SRF
Measured: 3 week, 7 week, 12 week
Change of the central retinal thickness (CRT)
CRT
Measured: 3 week, 7 week, 12 week
laser scar in area lasered on
colour image and OCT infared image
Measured: 12 week
the number of patients need retreatment
PRN (pro re nata), only for SRF not completely absorbed and CRT >=250um
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChoroidopathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Hospital of Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoling Liu, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735213
- Sponsor's protocol ID
- Y-2016005
- Status last verified
- Jul 2019
- First submitted
- 16 Mar 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salehi M, Wenick AS, Law HA, Evans JR, Gehlbach P. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2015 Dec 22;2015(12):CD011841. doi: 10.1002/14651858.CD011841.pub2.
PubMed 26691378Iacono P, Battaglia Parodi M, Falcomata B, Bandello F. Central Serous Chorioretinopathy Treatments: A Mini Review. Ophthalmic Res. 2015;55(2):76-83. doi: 10.1159/000441502. Epub 2015 Dec 1.
PubMed 26619293Daruich A, Matet A, Dirani A, Bousquet E, Zhao M, Farman N, Jaisser F, Behar-Cohen F. Central serous chorioretinopathy: Recent findings and new physiopathology hypothesis. Prog Retin Eye Res. 2015 Sep;48:82-118. doi: 10.1016/j.preteyeres.2015.05.003. Epub 2015 May 27.
PubMed 26026923Loo RH, Scott IU, Flynn HW Jr, Gass JD, Murray TG, Lewis ML, Rosenfeld PJ, Smiddy WE. Factors associated with reduced visual acuity during long-term follow-up of patients with idiopathic central serous chorioretinopathy. Retina. 2002 Feb;22(1):19-24. doi: 10.1097/00006982-200202000-00004.
PubMed 11884873Ficker L, Vafidis G, While A, Leaver P. Long-term follow-up of a prospective trial of argon laser photocoagulation in the treatment of central serous retinopathy. Br J Ophthalmol. 1988 Nov;72(11):829-34. doi: 10.1136/bjo.72.11.829.
PubMed 3061449
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-inferiority Study of the Use of Micropulse 577nm Laser vs Traditional Laser Treatment in Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT02735213
- Acronym / sponsor ID
- Y-2016005
- Conditions
- Central Serous Choroidopathy
- Keywords
- Central Serous Choroidopathy, Micropulse Laser Treatment, Traditional laser Treatment, optical coherence tomography
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- The Eye Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
The purpose of this study is to observe whether micropulse laser (MPL) is noninferiority to traditional laser therapy in central serous chorioretinopathy.
Detailed description
Central serous chorioretinopathy (CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity. Some studies have shown that traditional laser treatment (TLT) is effective on CSC, although accompanied with side-effects, such as scar. Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between TLT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus traditional laser treatment in central serous chorioretinopathy. It is a noninferiority study. The investigators hypothesize that application of 577nm micropulse laser in patients with CSC will prompt resolution of CSC as measured by ocular coherence tomography and best corrected visual acuity.This will be a pilot study to establish sound methods and provide some insights to the safety and efficacy of CSC treatment. The primary outcome measures is the change of BCVA in 12 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 577-MPL | Experimental | Device: 577-MPL577nm subthreshold micropulse laser(577-MPL) will be performed on the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein. Multiple laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um. |
| TLT | Active comparator | Device: TLTTraditional laser will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Traditional laser spots will be applied, covering the leakage area. Retreatment will be given in 12 weeks If SRF is not completely absorbed and CRT>= 250um. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with CSC；
- age>=18 years old;
- Duration is less than 6 months；
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT), and CRT>=250um;
- active leakage located at ring 2 and ring 3 (ETDRS rings) on fluorescein angiography (FA).
Key exclusion criteria (4 listed)
- Patients with no case of CSC；
- Patients with other macular comorbidities including but not limited to diabetic retinopathy, macular degeneration；
- Patients with prior retinal treatment less than 3 months；
- Inability to obtain photographs or to perform FA
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 |
|---|---|---|
| 577-MPL9 spots multispot micropulse mode(without spacing between the spots),160 um spot size, 0.2 second duration, 5% duty cycle(ON time 0.1ms + OFF time 1.9ms), and 250~400 milliWatts of power(50% threshold power),150~200 spots, the laser area is the corresponding leakage on mid-phase FA and around leakage. | Device | 577-MPL |
| TLTcontimuous wave,100um spot size, 0.05 seconds duration, 55~60 milliwatts of power, 18~27 spots,the laser area is the corresponding leakage on mid-phase FA. | Device | TLT |
Primary outcome
Change of Best Corrected Visual Acuity (BCVA)
Time frame: 12 week
ETDRS BCVA
4 secondary outcomes
the number of patients without any subretinal fluid (SRF)
Time frame: 3 week, 7 week, 12 week
Change of the central retinal thickness (CRT)
Time frame: 3 week, 7 week, 12 week
laser scar in area lasered on
Time frame: 12 week
the number of patients need retreatment
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Background: PubMed 26691378Salehi M, Wenick AS, Law HA, Evans JR, Gehlbach P. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2015 Dec 22;2015(12):CD011841. doi: 10.1002/14651858.CD011841.pub2.
- Background: PubMed 26619293Iacono P, Battaglia Parodi M, Falcomata B, Bandello F. Central Serous Chorioretinopathy Treatments: A Mini Review. Ophthalmic Res. 2015;55(2):76-83. doi: 10.1159/000441502. Epub 2015 Dec 1.
- Background: PubMed 26026923Daruich A, Matet A, Dirani A, Bousquet E, Zhao M, Farman N, Jaisser F, Behar-Cohen F. Central serous chorioretinopathy: Recent findings and new physiopathology hypothesis. Prog Retin Eye Res. 2015 Sep;48:82-118. doi: 10.1016/j.preteyeres.2015.05.003. Epub 2015 May 27.
- Background: PubMed 11884873Loo RH, Scott IU, Flynn HW Jr, Gass JD, Murray TG, Lewis ML, Rosenfeld PJ, Smiddy WE. Factors associated with reduced visual acuity during long-term follow-up of patients with idiopathic central serous chorioretinopathy. Retina. 2002 Feb;22(1):19-24. doi: 10.1097/00006982-200202000-00004.
- Background: PubMed 3061449Ficker L, Vafidis G, While A, Leaver P. Long-term follow-up of a prospective trial of argon laser photocoagulation in the treatment of central serous retinopathy. Br J Ophthalmol. 1988 Nov;72(11):829-34. doi: 10.1136/bjo.72.11.829.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 577-MPL and TLT in people with Central Serous Choroidopathy, run by The Eye Hospital of Wenzhou Medical University at 1 site in China.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jul 2019. 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 China. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of Best Corrected Visual Acuity (BCVA) (time frame: 12 week). 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 NCT02735213, which also lists 5 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 18 Jul 2019.