Viewing Study NCT03551574



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Last Modification Date: 2024-10-26 @ 12:47 PM
Study NCT ID: NCT03551574
Status: COMPLETED
Last Update Posted: 2020-09-09
First Post: 2018-05-10

Brief Title: Adaptive Optics in PVR
Sponsor: Moorfields Eye Hospital NHS Foundation Trust
Organization: Moorfields Eye Hospital NHS Foundation Trust

Study Overview

Official Title: An Observational Study of Retinal Function and Structure After Repair of Macula-involving Retinal Detachment Complicated by Proliferative Vitreoretinopathy RDPVR Using Adaptive Optics
Status: COMPLETED
Status Verified Date: 2020-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to investigate the loss of retinal cells following retinal detachment surgery using an imaging device called an adaptive optics camera The retina is a thin layer which lines the back of the eye It is sensitive to light like the film in a camera and is necessary for vision If a hole or rip develops in a retina it can become detached The macula is the central portion of the retina which the investigators use for fine vision This area can also become detached as part of a retinal detachment Proliferative vitreoretinopathy PVR is an abnormal scarring response inside the eye which can occur when the retina detaches It can adversely affect the outcome of the retinal detachment repair and is associated with a worse visual prognosis The investigators want to investigate retinal cell loss in patients with retinal detachments that have developed PVR when the macula has been involved

The investigators plan to compare them to two other groups of patients who have not developed PVR

1 Patients with macula-involving retinal detachments without PVR
2 Patients with macula-sparing detachments without PVR

The investigators will investigate retinal cell loss in these types of retinal detachments using adaptive optics imaging This is a non-invasive imaging technique which allows the investigators to view the retina at very high magnification Investigating photoreceptor loss and its association with visual outcome in this way should help to guide future interventions in promoting retinal regeneration The investigators plan to recruit 25 patients at one UK hospital The project is funded by the charity Fight for Sight
Detailed Description: A cohort of 10 cases of macula-involving retinal detachment complicated by proliferative vitreoretinopathy grade C RDPVR group will be identified from vitreoretinal clinics at Moorfields Eye Hospital 26 weeks following retinal detachment repair and after removal of any silicone oil tamponade these cases will undergo post-operative visual assessment OCT imaging and microperimetry These investigations will be correlated with adaptive optics AO enface imaging of cone photoreceptors at the macula This will be compared with groups of 10 cases of macula involving retinal detachment without PVR RD-OFF and 5 cases of macula-sparing retinal detachment RD-ON Both comparison groups RD-OFF RD-ON will undergo assessments at both 6 weeks and 26 weeks post-operatively

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None