AmblyopiaNCT01179763
Thickness of Retinal Layers in Amblyopia
An observational study of Amblyopia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to examine retinal layer thickness in amblyopia. Read more about this study
- Who is it for?
- Ages 4 to 19 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- Optical coherence tomography
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients in tertiary hospital
Who may be able to join
- Amblyopia
Who cannot join
- Other retinal disease
- Anisometropia
- Neurologic abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Spectral Domain Optical Coherence Tomography Measurements in Amblyopia
The purpose of this study is to examine retinal layer thickness in amblyopia.
Read the detailed description
Amblyopia is a visual disorder characterized by a reduction of vision that cannot be immediately improved by refractive correction or accounted for by clinically determined anatomic defects of the eye or visual pathway. Evidence for direct retinal changes in eyes with amblyopia has been controversial. It has been hypothesized that amblyopia may affect the postnatal maturation of the retina including the postnatal reduction of retinal ganglion cells. However, although some studies have found incrased retinal nerve fiber layer thickness in amblyopic eyes, others have found no significant differences. This sutdy will examine the retinal layer thickness in amblyopia and compare the retinal layer thickness between amblyopic eyes and nonamblyopic fellow eyes.
- Conditions
- Amblyopia
- Being tested
- Optical coherence tomography
- Keywords
- Amblyopia, Retinal layer thickness
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyOther
Also called Spectralis Optical coherence tomography
Spectral domain optical coherence tomography will be conducted once when patients are enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Retinal layer thickness analysis | Optical coherence tomography will be conducted to analyze retinal layer thickness (safe examination) Receives: Other: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal layer thickness
Optical coherence tomography scan will be conducted to analyze retinal layer thickness, when the patient are enrolled.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sei Yeul Oh, M.D., Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179763
- Sponsor's protocol ID
- 2009-12-089
- Status last verified
- Aug 2010
- First submitted
- 5 Aug 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Altintas O, Yuksel N, Ozkan B, Caglar Y. Thickness of the retinal nerve fiber layer, macular thickness, and macular volume in patients with strabismic amblyopia. J Pediatr Ophthalmol Strabismus. 2005 Jul-Aug;42(4):216-21. doi: 10.3928/01913913-20050701-03.
PubMed 16121551
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Spectral Domain Optical Coherence Tomography Measurements in Amblyopia
- ClinicalTrials.gov ID
- NCT01179763
- Acronym / sponsor ID
- 2009-12-089
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Retinal layer thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine retinal layer thickness in amblyopia.
Detailed description
Amblyopia is a visual disorder characterized by a reduction of vision that cannot be immediately improved by refractive correction or accounted for by clinically determined anatomic defects of the eye or visual pathway. Evidence for direct retinal changes in eyes with amblyopia has been controversial. It has been hypothesized that amblyopia may affect the postnatal maturation of the retina including the postnatal reduction of retinal ganglion cells. However, although some studies have found incrased retinal nerve fiber layer thickness in amblyopic eyes, others have found no significant differences. This sutdy will examine the retinal layer thickness in amblyopia and compare the retinal layer thickness between amblyopic eyes and nonamblyopic fellow eyes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal layer thickness analysis | – | Other: Optical coherence tomographyOptical coherence tomography will be conducted to analyze retinal layer thickness (safe examination) |
Who may qualify
- Ages
- 4 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients in tertiary hospital
Key inclusion criteria (1 listed)
- Amblyopia
Key exclusion criteria (3 listed)
- Other retinal disease
- Anisometropia
- Neurologic abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomographyAlso: Spectralis Optical coherence tomographySpectral domain optical coherence tomography will be conducted once when patients are enrolled. | Other | Retinal layer thickness analysis |
Primary outcome
Retinal layer thickness
Time frame: One month
Optical coherence tomography scan will be conducted to analyze retinal layer thickness, when the patient are enrolled.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
- Background: PubMed 16121551Altintas O, Yuksel N, Ozkan B, Caglar Y. Thickness of the retinal nerve fiber layer, macular thickness, and macular volume in patients with strabismic amblyopia. J Pediatr Ophthalmol Strabismus. 2005 Jul-Aug;42(4):216-21. doi: 10.3928/01913913-20050701-03.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sei Yeul Oh, M.D. study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amblyopia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal layer thickness (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01179763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010.