NCT01587794

Brief 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 retinal layers after resolution of recent-onset rhegmatogenous retinal detachment (RRD) using optical coherence tomography images.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 31, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

March 31, 2012

Last Update Submit

April 26, 2012

Conditions

Keywords

Rhegmatogenous retinal detachmentthickness of retinal layerouter nuclear layerphotoreceptor layer

Outcome Measures

Primary Outcomes (1)

  • 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.

    At least 6 months after the operation

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 31, 2012

First Posted

April 30, 2012

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 30, 2012

Record last verified: 2012-04