NCT03551574

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

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 13, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2018

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

May 10, 2018

Last Update Submit

September 7, 2020

Conditions

Retinal Detachment

Outcome Measures

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.

    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.

    6 months

Secondary Outcomes (7)

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

    6 months

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

    6 months

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

    6 months

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

    6 months

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

    6 months

  • +2 more secondary outcomes

Study Arms (1)

Macular involving retinal detachment

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2018

First Posted

June 11, 2018

Study Start

April 13, 2017

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

GB(1)