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Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy

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ClinicalTrials.gov Identifier: NCT01982383
Recruitment Status : Terminated (lack of enrollment)
First Posted : November 13, 2013
Results First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
George Washington University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Central Serous Chorioretinopathy
Interventions Device: Micropulse Laser Treatment
Other: No treatment
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Micropulse Laser Treatment No Treatment
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 2 0
Completed 2 0
Not Completed 0 0
Arm/Group Title Micropulse Laser Treatment No Treatment Total
Hide Arm/Group Description

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

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

Total of all reporting groups
Overall Number of Baseline Participants 2 0 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
>=65 years
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
Female
2
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Resolution of Fluid Build-up
Hide Description 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.
Time Frame within 1 week to 3 months after the laser procedure is completed
Hide Outcome Measure Data
Hide Analysis Population Description
No data analyzed. Study terminated due to lack of enrollment
Arm/Group Title Micropulse Laser Treatment No Treatment
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Micropulse Laser Treatment No Treatment
Hide Arm/Group Description

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

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

All-Cause Mortality
Micropulse Laser Treatment No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Micropulse Laser Treatment No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Micropulse Laser Treatment No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/0