Adaptive Optics in PVR

Retinal Detachment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551574
• Other study ID #: CHAD1033
• Status: Completed
• Start date: April 13, 2017
• Est. completion date: June 4, 2018

Study information

• Verified date: September 2020
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 4, 2018
• Est. primary completion date: June 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Detachment

Locations

Country	Name	City	State
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Estimate differences in cone mosaics in the PVR-RD vs RD-OFF groups.	Estimate differences in cone mosaics in the PVR-RD vs RD-OFF groups.	6 months
Secondary	Estimate differences in cone mosaics in the PVR-RD & RD-ON groups.3	Estimate differences in cone mosaics in the PVR-RD & RD-ON groups.	6 months
Secondary	Estimate differences in cone mosaics in the RD-OFF & RD-ON groups	Estimate differences in cone mosaics in the RD-OFF & RD-ON groups	6 months
Secondary	Estimate correlation between cone mosaics and post-operative visual acuity & microperimetry	Estimate correlation between cone mosaics and post-operative visual acuity & microperimetry	6 months
Secondary	Estimate correlation between cone mosaics and retinal layer changes on SD-OCT	Estimate correlation between cone mosaics and retinal layer changes on SD-OCT	6 months
Secondary	Estimate differences in cone mosaics at 6 weeks and 26 weeks following retinal detachment repair (RD-OFF & RD-ON groups only)	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)	6 months
Secondary	Exploratory correlation comparison between visual function variables in PVR patients, and various matrices of cone mosaic from AOC	Exploratory correlation comparison between visual function variables in PVR patients, and various matrices of cone mosaic from AOC	6 months