Trial Outcomes & Findings for Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy (NCT NCT01982383)
NCT ID: NCT01982383
Last Updated: 2018-03-27
Results Overview
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.
TERMINATED
NA
2 participants
within 1 week to 3 months after the laser procedure is completed
2018-03-27
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study on the Use of Micropulse Laser to Treat Central Serous Chorioretinopathy
Baseline characteristics by cohort
| Measure |
Micropulse Laser Treatment
n=2 Participants
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
|
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
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
—
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within 1 week to 3 months after the laser procedure is completedPopulation: No data analyzed. Study terminated due to lack of enrollment
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.
Outcome measures
Outcome data not reported
Adverse Events
Micropulse Laser Treatment
No Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place