FindTrial
Sign In

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00803517
Enrollment
24
Registered
2008-12-05
Start date
2008-03-31
Completion date
2008-10-31
Last updated
2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Serous Chorioretinopathy

Keywords

chronic central serous chorioretinopathy, multifocal electroretinogram, central retinal function after treatment in chronic serous chorioretinopathy

Brief summary

This study is a comparison of multifocal electroretinogram assessment between the laser treatment group and the photodynamic therapy group in chronic central serous chorioretinopathy.

Detailed description

1. Laser Group: extrafoveal focal leakage on FAG 2. PDT Group: no definite focal leak on FAG subfoveal or juxtafoveal focal leakage on FAG, or serous retinal pigmentary epithelial detachment involving foveal center Inclusion criteria 1. Chronic serous chorioretinopathy (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and OCT 2. Ability to maintain steady fixation for mfERG 3. Presence of abnormal dilated choroidal vasculature in ICGA 4. Symptom duration over 3 months Exclusion criteria 1. previous PDT or laser treatment history 2. evidence of Choriinal neovascularization in FAG 3. other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies follow-up Visit 1)baseline 2)1month 3)3months 4)6 months each visit: multifocal electroretinogram, visual acuity, optical coference timography should be measured.

Interventions

None listed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. CSC (over 3 months) when subretinal fluid persisted in the subfoveal region demonstrated by clinical examination and OCT 2. Ability to maintain steady fixation for mfERG 3. Presence of abnormal dilated choroidal vasculature in ICGA 4. Symptom duration over 3 months

Exclusion criteria

1. Previous PDT or laser treatment history 2. Evidence of CNV in FAG 3. Other chorioretinal disorders that can cause macular exudation such as age-related macular degeneration, pathologic myopia, angioid streaks, trauma, inflammatory diseases, retinal vasculopathies, and hereditary dystrophies

Design outcomes

Primary

MeasureTime frameDescription
Multifocal Electroretinogram Amplitudesbaseline, 1 month, 3 months, 6 monthsAmplitude 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.

Secondary

MeasureTime frameDescription
Best Corrected Visual Acuitybaseline, 1 month, 3 months, 6 monthsBest-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.

Countries

South Korea

Participant flow

Participants by arm

ArmCount
Photodynamic Therapy12
Focal Laser Photocoagulation12
Total24

Baseline characteristics

CharacteristicFocal Laser PhotocoagulationPhotodynamic TherapyTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
12 Participants12 Participants24 Participants
Age Continuous44.26 years
STANDARD_DEVIATION 5.89
42.35 years
STANDARD_DEVIATION 6.89
43.31 years
STANDARD_DEVIATION 7.89
Region of Enrollment
Korea, Republic of
12 participants12 participants24 participants
Sex: Female, Male
Female
1 Participants1 Participants2 Participants
Sex: Female, Male
Male
11 Participants11 Participants22 Participants

Outcome results

Primary

Multifocal Electroretinogram Amplitudes

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.

Time frame: baseline, 1 month, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Photodynamic TherapyMultifocal Electroretinogram Amplitudes1 month29.7 microvoltsStandard Deviation 7.2
Photodynamic TherapyMultifocal Electroretinogram Amplitudes6 months40.3 microvoltsStandard Deviation 6.7
Photodynamic TherapyMultifocal Electroretinogram Amplitudes3 months39.9 microvoltsStandard Deviation 8.7
Photodynamic TherapyMultifocal Electroretinogram Amplitudesbaseline28.4 microvoltsStandard Deviation 8.6
Focal Laser PhotocoagulationMultifocal Electroretinogram Amplitudes3 months37.6 microvoltsStandard Deviation 10.9
Focal Laser PhotocoagulationMultifocal Electroretinogram Amplitudes6 months38.6 microvoltsStandard Deviation 12.3
Focal Laser PhotocoagulationMultifocal Electroretinogram Amplitudes1 month36.1 microvoltsStandard Deviation 13.6
Focal Laser PhotocoagulationMultifocal Electroretinogram Amplitudesbaseline32.2 microvoltsStandard Deviation 10.46
Secondary

Best Corrected Visual Acuity

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.

Time frame: baseline, 1 month, 3 months, 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Photodynamic TherapyBest Corrected Visual Acuitybaseline0.22 logMARStandard Deviation 0.17
Photodynamic TherapyBest Corrected Visual Acuity1 month0.07 logMARStandard Deviation 0.02
Photodynamic TherapyBest Corrected Visual Acuity3 months0.05 logMARStandard Deviation 0.02
Photodynamic TherapyBest Corrected Visual Acuity6 months0.05 logMARStandard Deviation 0.02
Focal Laser PhotocoagulationBest Corrected Visual Acuity6 months0.04 logMARStandard Deviation 0.02
Focal Laser PhotocoagulationBest Corrected Visual Acuitybaseline0.15 logMARStandard Deviation 0.13
Focal Laser PhotocoagulationBest Corrected Visual Acuity3 months0.04 logMARStandard Deviation 0.02
Focal Laser PhotocoagulationBest Corrected Visual Acuity1 month0.08 logMARStandard Deviation 0.14

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026