Acute Central Serous ChorioretinopathyNCT02784665
Treatment Trial for Acute Central Serous Chorioretinopathy
A study testing 577-MPL and 577-TL in people with Acute Central Serous Chorioretinopathy, run by Jin Chen-jin at 1 site in China.
Trial summary
Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger patients. It is characterized by serous detachment of the neurosensory retina with or without serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image distortion, loss of color and contrast… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Central Serous Chorioretinopathy
- What is being tested?
- 577-MPL and 577-TL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Mar 2018
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- onset for the first time, as an episode duration of less than 6 months
- patient was between 18 and 55 years of age
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
- active fluorescein leakage during fluorescein angiography (FA)
- best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
Who cannot join
- previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
- other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
- retinal atrophy
- pregnancy
- inability to obtain photographs or to perform FA
- use of steroid systemically or topically in the last 6 months
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy
Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger patients. It is characterized by serous detachment of the neurosensory retina with or without serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be treated with traditional laser photocoagulation, but it has the side effects of causing RPE atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment but it's more than most families can afford to pay because of the high cost, what's more, it is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium (RPE) atrophy and RPE rip.
To date there is no international consensus on the optimal treatment of CSC Many retrospective studies suggest that micropulse laser (MPL) therapy may also be effective without obvious complications in this disease.
The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute central serous chorioretinopathy compared with the traditional laser coagulation.
Read the detailed description
The study is a prospective randomized controlled trial about 577nm micropulse laser versus traditional laser coagulation therapy on acute central serous chorioretinopathy. The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid 3 months after treatment.
- Conditions
- Acute Central Serous Chorioretinopathy
- Being tested
- 577-MPL, 577-TL
- Keywords
- CSC, Micropulse Laser, Traditional Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
577-MPLDevice
All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the
577-TLDevice
All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-TL arm.
100 microns light spot size, 0.05 seconds duration, 80 ~ 200 milliwatts of power
| Study group | Role | What they receive |
|---|---|---|
| 577-MPL | Experimental | 577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area. Receives: Device: 577-MPL |
| 577-TL | Active comparator | 577nm Traditional laser(577-TL) 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. Receives: Device: 577-TL |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of eyes with complete absorption of subretinal fluid (SRF)
The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)
Measured: 3 month
Secondary outcomes (3)
Change of Best Corrected Visual Acuity (BCVA)
Measured: 1months,3 months and 6 months
Change of fundus autofluorescence
Fundus autofluorescence will be evaluated for different patterns (normal, increased, and decreased) before and after treatment
Measured: 1months,3 months and 6 months
Change in 10° retinal sensitivity
Measured: baseline,1months,3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jin Chen-jin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Chen-jin, Sun Yat-sen University
- Investigators
- Chenjin Jin, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784665
- Sponsor's protocol ID
- 577MPTAC
- Status last verified
- Aug 2018
- First submitted
- 23 May 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Traditional Laser Therapy on Acute Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT02784665
- Acronym / sponsor ID
- 577MPTAC
- Conditions
- Acute Central Serous Chorioretinopathy
- Keywords
- CSC, Micropulse Laser, Traditional Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Jin Chen-jinUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 27 May 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.
Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger patients. It is characterized by serous detachment of the neurosensory retina with or without serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be treated with traditional laser photocoagulation, but it has the side effects of causing RPE atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment but it's more than most families can afford to pay because of the high cost, what's more, it is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium (RPE) atrophy and RPE rip.
To date there is no international consensus on the optimal treatment of CSC Many retrospective studies suggest that micropulse laser (MPL) therapy may also be effective without obvious complications in this disease.
The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute central serous chorioretinopathy compared with the traditional laser coagulation.
Detailed description
The study is a prospective randomized controlled trial about 577nm micropulse laser versus traditional laser coagulation therapy on acute central serous chorioretinopathy. The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid 3 months after treatment.
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 micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area. |
| 577-TL | Active comparator | Device: 577-TL577nm Traditional laser(577-TL) 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- onset for the first time, as an episode duration of less than 6 months
- patient was between 18 and 55 years of age
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
- active fluorescein leakage during fluorescein angiography (FA)
- best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
Key exclusion criteria (6 listed)
- previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
- other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
- retinal atrophy
- pregnancy
- 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-MPLAll treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the | Device | 577-MPL |
| 577-TLAll treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-TL arm. 100 microns light spot size, 0.05 seconds duration, 80 ~ 200 milliwatts of power | Device | 577-TL |
Primary outcome
the proportion of eyes with complete absorption of subretinal fluid (SRF)
Time frame: 3 month
The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)
3 secondary outcomes
Change of Best Corrected Visual Acuity (BCVA)
Time frame: 1months,3 months and 6 months
Change of fundus autofluorescence
Time frame: 1months,3 months and 6 months
Change in 10° retinal sensitivity
Time frame: baseline,1months,3 months and 6 months
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 15 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Central Serous Chorioretinopathy
Not yet recruitingPhase 2/3
Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
Central Serous Chorioretinopathy, Melatonin
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.
Chenjin Jin principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 577-MPL and 577-TL in people with Acute Central Serous Chorioretinopathy, run by Jin Chen-jin 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 6 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 15 Aug 2018. 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.
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?
the proportion of eyes with complete absorption of subretinal fluid (SRF) (time frame: 3 month). 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 15 Aug 2018.