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Adaptive Optics in PVR

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ClinicalTrials.gov Identifier: NCT03551574
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

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.


Condition or disease
Retinal Detachment

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 Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Macular involving retinal detachment
Patients with retinal detachments that have developed PVR when the macula has been involved



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with retinal detachments that have developed PVR when the macula has been involved
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551574


Contacts
Contact: Moorfields R&D 020 7253 3411 ext 2937 res-admin@moorfields.nhs.uk

Locations
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Moorfields R&D    020 7253 3411 ext 2937    res-admin@moorfields.nhs.uk   
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust

Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03551574     History of Changes
Other Study ID Numbers: CHAD1033
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases