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lack of enrollment
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The investigators hypothesis is that using the micropulse laser in patient with Central Serous Chorioretinopathy (CSC) will prompt resolution of CSC and will be effective in significantly minimizing visual recovery time from this disease as well as potentially preventing recurrences.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micropulse Laser Treatment | Experimental | Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine |
|
| No Treatment | Placebo Comparator | Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micropulse Laser Treatment | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Fluid Build-up | Central Serous Choroidopathy is a disease that causes fluid to build up under the retina,the back part of the inner eye that sends sight information to the brain. The objective here is to apply 577nm of micropulse laser to see if CSC resolution occurs and measuring it through ocular coherence tomography (retinal imaging), vision score, and visual field testing for retinal sensitivity. | within 1 week to 3 months after the laser procedure is completed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeevan Mathura, MD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15005592 | Background | Ricci F, Missiroli F, Cerulli L. Indocyanine green dye-enhanced micropulsed diode laser: a novel approach to subthreshold RPE treatment in a case of central serous chorioretinopathy. Eur J Ophthalmol. 2004 Jan-Feb;14(1):74-82. doi: 10.1177/112067210401400115. | |
| 18988165 | Background | Lanzetta P, Furlan F, Morgante L, Veritti D, Bandello F. Nonvisible subthreshold micropulse diode laser (810 nm) treatment of central serous chorioretinopathy. A pilot study. Eur J Ophthalmol. 2008 Nov-Dec;18(6):934-40. doi: 10.1177/112067210801800613. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Micropulse Laser Treatment | Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine Micropulse Laser Treatment |
| FG001 | No Treatment | Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending No treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Micropulse Laser Treatment | Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine Micropulse Laser Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resolution of Fluid Build-up | Central Serous Choroidopathy is a disease that causes fluid to build up under the retina,the back part of the inner eye that sends sight information to the brain. The objective here is to apply 577nm of micropulse laser to see if CSC resolution occurs and measuring it through ocular coherence tomography (retinal imaging), vision score, and visual field testing for retinal sensitivity. | No data analyzed. Study terminated due to lack of enrollment | Posted | within 1 week to 3 months after the laser procedure is completed |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Micropulse Laser Treatment | Patient's randomized to ML treatment would be treated with the following settings: 200 micron spot size, 0.2 second duration, 15% duty cycle, and 300 milliWatt power. Their eyes would be dilated prior to treatment with standard mydriatic medications, including Tropicamide and Phenylephrine Micropulse Laser Treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Swanson | Medical Faculty Associates | 202-741-2437 | nswanson@mfa.gwu.edu |
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| ID | Term |
|---|---|
| D056833 | Central Serous Chorioretinopathy |
| D004487 | Edema |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| No treatment |
| Other |
|
| 19041477 | Background | Chen SN, Hwang JF, Tseng LF, Lin CJ. Subthreshold diode micropulse photocoagulation for the treatment of chronic central serous chorioretinopathy with juxtafoveal leakage. Ophthalmology. 2008 Dec;115(12):2229-34. doi: 10.1016/j.ophtha.2008.08.026. |
| 40522203 | Derived | Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3. |
| BG001 |
| No Treatment |
Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending No treatment |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | No Treatment | Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending No treatment |
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | No Treatment | Patients randomized to this treatment arm, will not receive treatment for CSC. They will continue to be observed at month 1 and month 3. If any worsening of pathology is found during the follow up visits, the patient will be removed from the study and given appropriate standard of care by the attending No treatment | 0 | 0 | 0 | 0 | 0 | 0 |
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