Topographic Changes of Retinal Layers After Resolution of Acute Retinal Detachment

April 26, 2012 updated by: Se Woong, Kang, Samsung Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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:

Exclusion Critetia:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At least 6 months after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2011-3-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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