CClinicalTrials.gg
CompletedNCT00803517Updated Mar 12, 2009Results posted

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

An observational study in Central Serous Chorioretinopathy, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-03-12.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
24
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Central Serous Chorioretinopathy

Keywords

  • chronic central serous chorioretinopathy
  • multifocal electroretinogram
  • central retinal function after treatment in chronic serous chorioretinopathy
03

In context

Central Serous Chorioretinopathy

86 studies on the registry are indexed under Central Serous Chorioretinopathy; 13 are open to participants now.

This study's enrollment of 24 is below the median of 83 across 21 observational studies indexed under Central Serous Chorioretinopathy.

Browse Central Serous Chorioretinopathy studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  1. Laser Group: extrafoveal focal leakage on FAG
  2. photodynamic therapy Group: no definite focal leak on FAG subfoveal or juxtafoveal focal leakage on FAG, or s-RPED involving foveal center

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
24 participants (actual)

Groups and cohorts

  • Photodynamic therapy (PDT)
  • Focal laser photocoagulation (focal)
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Results

Posted Dec 5, 2008

Participant flow

Participant flow — Overall Study
MilestonePhotodynamic TherapyFocal Laser Photocoagulation
Started1212
Completed1212
Not completed00

Outcome measures

PrimaryMultifocal 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
Reported as:
Mean · microvolts
Multifocal Electroretinogram Amplitudes
microvoltsPhotodynamic TherapyFocal Laser Photocoagulation
baseline28.4 ± 8.632.2 ± 10.46
1 month29.7 ± 7.236.1 ± 13.6
3 months39.9 ± 8.737.6 ± 10.9
6 months40.3 ± 6.738.6 ± 12.3
SecondaryBest 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
Reported as:
Mean · logMAR
Best Corrected Visual Acuity
logMARPhotodynamic TherapyFocal Laser Photocoagulation
baseline0.22 ± 0.170.15 ± 0.13
1 month0.07 ± 0.020.08 ± 0.14
3 months0.05 ± 0.020.04 ± 0.02
6 months0.05 ± 0.020.04 ± 0.02

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Photodynamic TherapyFocal Laser PhotocoagulationTotal
<=18 years000
Between 18 and 65 years121224
>=65 years000
Age Continuous
Age Continuous(years)Photodynamic TherapyFocal Laser PhotocoagulationTotal
Mean42.35 ± 6.8944.26 ± 5.8943.31 ± 7.89
Sex: Female, Male
Sex: Female, Male(Participants)Photodynamic TherapyFocal Laser PhotocoagulationTotal
Female112
Male111122
Region of Enrollment
Region of Enrollment(participants)Photodynamic TherapyFocal Laser PhotocoagulationTotal
Korea, Republic of121224
08

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00803517
Lead sponsor
Samsung Medical Center
First posted
Dec 5, 2008
Start date
Mar 2008
Primary completion
Oct 2008
Completion
Oct 2008
Results posted
Dec 5, 2008
Last update
Mar 12, 2009

Study contacts

Se Woong Kang, MD
study chair · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion