Trial Outcomes & Findings for Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy (NCT NCT00803517)

NCT ID: NCT00803517

Last Updated: 2009-03-12

Results Overview

Amplitude at first annular ring at multifocal electroretinogram RETIscan (Roland Consult, Wiesbaden, Germany) is used for multifocal retinogram. The recording protocol was chosen according to the International Society for Clinical Electro-physiology of Vision (ISCEV) guidelines.

• Recruitment status: COMPLETED
• Target enrollment: 24 participants
• Primary outcome timeframe: baseline, 1 month, 3 months, 6 months
• Results posted on: 2009-03-12

Participant Flow

Participant milestones

Measure	Photodynamic Therapy	Focal Laser Photocoagulation
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Multifocal Electroretinogram Assessment in Chronic Central Serous Chorioretinopathy (CSC) Between Laser Treatment Group and Photodynamic Therapy Group in Chronic Central Serous Chorioretinopathy

Baseline characteristics by cohort

Measure	Photodynamic Therapy n=12 Participants	Focal Laser Photocoagulation n=12 Participants	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	42.35 years STANDARD_DEVIATION 6.89 • n=5 Participants	44.26 years STANDARD_DEVIATION 5.89 • n=7 Participants	43.31 years STANDARD_DEVIATION 7.89 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Korea, Republic of	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 1 month, 3 months, 6 months

Amplitude at first annular ring at multifocal electroretinogram RETIscan (Roland Consult, Wiesbaden, Germany) is used for multifocal retinogram.

The recording protocol was chosen according to the International Society for Clinical Electro-physiology of Vision (ISCEV) guidelines.

Outcome measures

Measure	Photodynamic Therapy n=12 Participants	Focal Laser Photocoagulation n=12 Participants
Multifocal Electroretinogram Amplitudes baseline	28.4 microvolts Standard Deviation 8.6	32.2 microvolts Standard Deviation 10.46
Multifocal Electroretinogram Amplitudes 1 month	29.7 microvolts Standard Deviation 7.2	36.1 microvolts Standard Deviation 13.6
Multifocal Electroretinogram Amplitudes 3 months	39.9 microvolts Standard Deviation 8.7	37.6 microvolts Standard Deviation 10.9
Multifocal Electroretinogram Amplitudes 6 months	40.3 microvolts Standard Deviation 6.7	38.6 microvolts Standard Deviation 12.3

SECONDARY outcome

Timeframe: baseline, 1 month, 3 months, 6 months

Best-corrected visual acuities were obtained with Snellen charts. Snellen's visual acuity was converted logarithm of the minimum angle of resolution (logMAR) for statistical analysis.

Outcome measures

Measure	Photodynamic Therapy n=12 Participants	Focal Laser Photocoagulation n=12 Participants
Best Corrected Visual Acuity baseline	0.22 logMAR Standard Deviation 0.17	0.15 logMAR Standard Deviation 0.13
Best Corrected Visual Acuity 1 month	0.07 logMAR Standard Deviation 0.02	0.08 logMAR Standard Deviation 0.14
Best Corrected Visual Acuity 3 months	0.05 logMAR Standard Deviation 0.02	0.04 logMAR Standard Deviation 0.02
Best Corrected Visual Acuity 6 months	0.05 logMAR Standard Deviation 0.02	0.04 logMAR Standard Deviation 0.02

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jiwon Lim

Samsung Medical Center

Phone: 82-10-9933-5596

Email: samnyasa@naver.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place