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OpenTrials
Completed

NCT Number: NCT01587794

Topographic Changes of Retinal Layers After Resolution of Acute Retinal Detachment

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Topographic Changes of Retinal Layers After Resolution of Acute Retinal

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2012
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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