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Completed

NCT Number: NCT03551574

Adaptive Optics in PVR

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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. The difference in cone density in patients following repair of macula-involving retinal detachment in eyes with PVR (RD-PVR), versus macula-involving retinal detachment without PVR (RD-OFF) at 26 weeks following retinal detachment repair.

    Time frame: 6 months

    The difference in cone density in patients following repair of macula-involving retinal detachment in eyes with PVR (RD-PVR), versus macula-involving retinal detachment without PVR (RD-OFF) at 26 weeks following retinal detachment repair. Images will be taken with an adaptive optics camera.

Secondary outcomes

  1. Estimate differences in cone mosaics in the PVR-RD vs RD-OFF groups.

    Time frame: 6 months

    Estimate differences in cone mosaics in the PVR-RD vs RD-OFF groups.

  2. Estimate differences in cone mosaics in the PVR-RD & RD-ON groups.3

    Time frame: 6 months

    Estimate differences in cone mosaics in the PVR-RD & RD-ON groups.

  3. Estimate differences in cone mosaics in the RD-OFF & RD-ON groups

    Time frame: 6 months

    Estimate differences in cone mosaics in the RD-OFF & RD-ON groups

  4. Estimate correlation between cone mosaics and post-operative visual acuity & microperimetry

    Time frame: 6 months

    Estimate correlation between cone mosaics and post-operative visual acuity & microperimetry

  5. Estimate correlation between cone mosaics and retinal layer changes on SD-OCT

    Time frame: 6 months

    Estimate correlation between cone mosaics and retinal layer changes on SD-OCT

  6. Estimate differences in cone mosaics at 6 weeks and 26 weeks following retinal detachment repair (RD-OFF & RD-ON groups only)

    Time frame: 6 months

    Estimate differences in cone mosaics at 6 weeks and 26 weeks following retinal detachment repair (RD-OFF & RDIRAS Estimate differences in cone mosaics at 6 weeks and 26 weeks following retinal detachment repair (RD-OFF & RD-ON groups only)

  7. Exploratory correlation comparison between visual function variables in PVR patients, and various matrices of cone mosaic from AOC

    Time frame: 6 months

    Exploratory correlation comparison between visual function variables in PVR patients, and various matrices of cone mosaic from AOC

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study title

An Observational Study of Retinal Function and Structure After Repair of Macula-involving Retinal Detachment Complicated by Proliferative Vitreoretinopathy (RDPVR) Using Adaptive Optics

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2018
Registry last updated
Sep 9, 2020

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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