Rhegmatogenous Retinal DetachmentNCT01587794
Topographic Changes of Retinal Layers After Resolution of Acute Retinal Detachment
An observational study of Rhegmatogenous Retinal Detachment, run by Samsung Medical Center.
Trial summary
Experimental retinal detachment and reattachment models have demonstrated the recovery process of successfully reattached retina. However, optical coherence tomography analysis of each retinal layers following retinal reattachment has not been investigated This study investigated changes in thickness profiles of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Apr 2011
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were diagnosed with unilateral RRD involving only the superior or inferior half of the retina and who underwent successful scleral buckling procedure or vitrectomy by a single surgeon between January 1, 2008 and April 1, 2010 were included in the study sample.
Who may be able to join
- Patients who could estimate the time of onset of visual symptom of retinal detachment (sudden decrease in visual acuity or onset of visual field defect) accurately
- Patients who were treated within 2 weeks of symptom onset Exclusion Criteria:
Who cannot join
- traumatic retinal detachment
- recurred retinal detachment
- less than 6 months of follow-up after surgery
- insufficient cooperation for optical coherence tomography examination
- media opacity that would preclude acquisition of clear optical coherence tomography images
- -6.0 diopters or more of spherical equivalent
Show all 11Show fewer
- prominent staphyloma
- history of intraocular surgery other than cataract surgery or intraocular lens implantation
- other ocular diseases that may influence the macular microstructure.
- individuals with indistinct intraretinal structure on optical coherence tomography images
- large retinal vessels at the location of thickness measurement, or epiretinal membrane
About this study
Official title: Topographic Changes of Retinal Layers After Resolution of Acute Retinal
Experimental retinal detachment and reattachment models have demonstrated the recovery process of successfully reattached retina. However, optical coherence tomography analysis of each retinal layers following retinal reattachment has not been investigated This study investigated changes in thickness profiles of retinal layers after resolution of recent-onset rhegmatogenous retinal detachment (RRD) using optical coherence tomography images.
Read the detailed description
Rhegmatogenous retinal detachment is a sight-threatening condition that occurs when the neurosensory retina separates from the underlying retinal pigment epithelium and fluid accumulates within this potential space.Surgical reattachment of a detached retina is the mainstay of treatment.
Experimental retinal detachment and reattachment models have demonstrated the recovery process of successfully reattached retina, including regrowth and reconfiguration of the photoreceptor inner and/or outer segments,reorganization of photoreceptor-RPE interface,increased synaptic terminals in the outer plexiform layer, inhibition of glial cell proliferation,and recovery of normal distribution of proteins. These microscopic changes are thought to be the reason for visual function recovery following retinal reattachment.
Recent development in spectral domain optical coherence tomography, which provides faster imaging speed and higher resolution, allows more detailed retinal layer evaluation. Previous studies using spectral domain optical coherence tomography have revealed abnormalities of retinal microstructure in reattached retina. However, these studies mainly focused on the photoreceptor layer and/or external limiting membrane, although abnormalities of various retinal layers have been revealed in previous microscopic studies. In addition, qualitative rather than quantitative analysis was performed in most of the studies, and most importantly, all previous studies were observational and comparisons between the affected and normal control regions were not performed.
The current study involves a series of recent-onset primary rhegmatogenous retinal detachment that were managed with surgical retinal reattachment. The investigators quantified the thickness of each retinal layer based on spectral domain optical coherence tomography images and compared the thicknesses of reattached regions and undetached normal regions. The primary purpose of this study was to evaluate the changes in thickness profiles of each retinal layer in reattached retina after acute RRD.
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Rhegmatogenous retinal detachment, thickness of retinal layer, outer nuclear layer, photoreceptor layer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| retinal detachment group | Patients who were diagnosed with unilateral rhegmatogenous retinal detachment involving only the superior or inferior half of the retina and who underwent successful scleral buckling procedure or vitrectomy by a single surgeon between January 1, 2008 and April 1, 2010 were included in the study sample. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of each retinal layer
SD-OCT scans were performed for all patients enrolled using Spectralis optical coherence tomography. The thickness of each retinal layer was measured manually using the included Heidelberg Eye Explorer software.
Measured: At least 6 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2010
- Primary completionApr 2011
- Study completionApr 2011
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 Rhegmatogenous Retinal DetachmentStudies 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
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se Woong, Kang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587794
- Sponsor's protocol ID
- 2011-3-31
- Status last verified
- Apr 2012
- First submitted
- 31 Mar 2012
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim JH, Park DY, Ha HS, Kang SW. Topographic changes of retinal layers after resolution of acute retinal detachment. Invest Ophthalmol Vis Sci. 2012 Oct 23;53(11):7316-21. doi: 10.1167/iovs.12-10155.
PubMed 23033395
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topographic Changes of Retinal Layers After Resolution of Acute Retinal
- ClinicalTrials.gov ID
- NCT01587794
- Acronym / sponsor ID
- 2011-3-31
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Rhegmatogenous retinal detachment, thickness of retinal layer, outer nuclear layer, photoreceptor layer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Apr 2012 (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.
Experimental retinal detachment and reattachment models have demonstrated the recovery process of successfully reattached retina. However, optical coherence tomography analysis of each retinal layers following retinal reattachment has not been investigated This study investigated changes in thickness profiles of retinal layers after resolution of recent-onset rhegmatogenous retinal detachment (RRD) using optical coherence tomography images.
Detailed description
Rhegmatogenous retinal detachment is a sight-threatening condition that occurs when the neurosensory retina separates from the underlying retinal pigment epithelium and fluid accumulates within this potential space.Surgical reattachment of a detached retina is the mainstay of treatment.
Experimental retinal detachment and reattachment models have demonstrated the recovery process of successfully reattached retina, including regrowth and reconfiguration of the photoreceptor inner and/or outer segments,reorganization of photoreceptor-RPE interface,increased synaptic terminals in the outer plexiform layer, inhibition of glial cell proliferation,and recovery of normal distribution of proteins. These microscopic changes are thought to be the reason for visual function recovery following retinal reattachment.
Recent development in spectral domain optical coherence tomography, which provides faster imaging speed and higher resolution, allows more detailed retinal layer evaluation. Previous studies using spectral domain optical coherence tomography have revealed abnormalities of retinal microstructure in reattached retina. However, these studies mainly focused on the photoreceptor layer and/or external limiting membrane, although abnormalities of various retinal layers have been revealed in previous microscopic studies. In addition, qualitative rather than quantitative analysis was performed in most of the studies, and most importantly, all previous studies were observational and comparisons between the affected and normal control regions were not performed.
The current study involves a series of recent-onset primary rhegmatogenous retinal detachment that were managed with surgical retinal reattachment. The investigators quantified the thickness of each retinal layer based on spectral domain optical coherence tomography images and compared the thicknesses of reattached regions and undetached normal regions. The primary purpose of this study was to evaluate the changes in thickness profiles of each retinal layer in reattached retina after acute RRD.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| retinal detachment group | – | –Patients who were diagnosed with unilateral rhegmatogenous retinal detachment involving only the superior or inferior half of the retina and who underwent successful scleral buckling procedure or vitrectomy by a single surgeon between January 1, 2008 and April 1, 2010 were included in the study sample. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were diagnosed with unilateral RRD involving only the superior or inferior half of the retina and who underwent successful scleral buckling procedure or vitrectomy by a single surgeon between January 1, 2008 and April 1, 2010 were included in the study sample.
Key inclusion criteria (2 listed)
- Patients who could estimate the time of onset of visual symptom of retinal detachment (sudden decrease in visual acuity or onset of visual field defect) accurately
- Patients who were treated within 2 weeks of symptom onset Exclusion Criteria:
Key exclusion criteria (11 listed)
- traumatic retinal detachment
- recurred retinal detachment
- less than 6 months of follow-up after surgery
- insufficient cooperation for optical coherence tomography examination
- media opacity that would preclude acquisition of clear optical coherence tomography images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thickness of each retinal layer
Time frame: At least 6 months after the operation
SD-OCT scans were performed for all patients enrolled using Spectralis optical coherence tomography. The thickness of each retinal layer was measured manually using the included Heidelberg Eye Explorer software.
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 30 Apr 2012.
- Derived from this study: PubMed 23033395Kim JH, Park DY, Ha HS, Kang SW. Topographic changes of retinal layers after resolution of acute retinal detachment. Invest Ophthalmol Vis Sci. 2012 Oct 23;53(11):7316-21. doi: 10.1167/iovs.12-10155.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhegmatogenous Retinal Detachment, run by Samsung Medical Center.
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 2 inclusion and 11 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Thickness of each retinal layer (time frame: At least 6 months after the operation). 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 NCT01587794, 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 30 Apr 2012.