Adaptive Optics in PVR

NCT ID: NCT03551574

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-13

Study Completion Date

2018-06-04

Brief Summary

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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

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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.

Conditions

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Retinal Detachment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Macular involving retinal detachment

Patients with retinal detachments that have developed PVR when the macula has been involved

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* RD-PVR group: patients who have had successful retinal surgery to treat macular-involving retinal detachment with PVR C.
* RD-OFF group: patients who have had successful retinal surgery to treat macular-involving retinal detachment without PVR.
* RD-ON group: patients who have had successful retinal surgery to treat macular-sparing retinal detachment without PVR.
* 18 years of age

Exclusion Criteria

* Media opacity precluding imaging (including silicone oil tamponade)
* Poor central fixation (defined as a fixation score of \<10 out of 20)
* Recent contact lens (CLs) wear in the last 48 hours
* Previous refractive surgery/ other corneal surgery
* Spherical equivalent refractive error exceeding -12 or +6D
* Irregularly shaped pupil
* Unable to be dilated
* Unable to give informed consent
* Ocular co-morbidity affecting visual outcome
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CHAD1033

Identifier Type: -

Identifier Source: org_study_id

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