Retinal DetachmentNCT03551574
Adaptive Optics in PVR
An observational study of Retinal Detachment, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Apr 2017to 4 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with retinal detachments that have developed PVR when the macula has been involved
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Unable to be dilated
- Unable to give informed consent
- Ocular co-morbidity affecting visual outcome
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London
About this study
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
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:
Read more
- Patients with macula-involving retinal detachments without PVR
- 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.
Read the 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.
- Conditions
- Retinal Detachment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Macular involving retinal detachment | Patients with retinal detachments that have developed PVR when the macula has been involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (7)
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.
Measured: 6 months
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.
Measured: 6 months
Estimate differences in cone mosaics in the RD-OFF & RD-ON groups
Estimate differences in cone mosaics in the RD-OFF \& RD-ON groups
Measured: 6 months
Estimate correlation between cone mosaics and post-operative visual acuity & microperimetry
Estimate correlation between cone mosaics and post-operative visual acuity \& microperimetry
Measured: 6 months
Estimate correlation between cone mosaics and retinal layer changes on SD-OCT
Estimate correlation between cone mosaics and retinal layer changes on SD-OCT
Measured: 6 months
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)
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start13 Apr 2017
- Primary completion4 Jun 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551574
- Sponsor's protocol ID
- CHAD1033
- Status last verified
- Sep 2020
- First submitted
- 10 May 2018
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03551574
- Acronym / sponsor ID
- CHAD1033
- Conditions
- Retinal Detachment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 4 Jun 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with macula-involving retinal detachments without PVR
- 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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macular involving retinal detachment | – | –Patients with retinal detachments that have developed PVR when the macula has been involved |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with retinal detachments that have developed PVR when the macula has been involved
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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 & RD-ON groups.3
Time frame: 6 months
Estimate differences in cone mosaics in the RD-OFF & RD-ON groups
Time frame: 6 months
Estimate correlation between cone mosaics and post-operative visual acuity & microperimetry
Time frame: 6 months
Estimate correlation between cone mosaics and retinal layer changes on SD-OCT
Time frame: 6 months
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
Exploratory correlation comparison between visual function variables in PVR patients, and various matrices of cone mosaic from AOC
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.