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Retinal DetachmentREVEALNCT04158622

Retinal Displacement Rates in Pneumatic Retinopexy Versus Pars Plana Vitrectomy For Primary Retinal Detachment

A study testing PnR + laser/cryotherapy and PPV + laser/cryotherapy in people with Retinal Detachment and Metamorphopsia, run by Unity Health Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients may experience metamorphopsia, or image distortion, after having vitrectomy to repair their rhegmatogenous retinal detachments (RRDs) especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Detachment, Metamorphopsia
What is being tested?
PnR + laser/cryotherapy and PPV + laser/cryotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
15 Mar 2021to Dec 2022
Phase
Interventional
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

Who may be able to join

  • Macula-off retinal detachment
  • Single retinal break OR group of breaks no larger than four clock hours apart between each other (Figure 2)
  • All breaks in detached retina must be between 3-9 o'clock (Figure 2, blue lines)
  • No significant proliferative vitreoretinopathy (PVR) (can have grade A or B)

Who cannot join

  • Inferior breaks in detached retina. NOTE: Patient can have any number, location and size of retinal breaks or lattice degeneration in attached retina.
  • Inability to read English language
  • Age < 18 years
  • Mental incapacity
  • Previous vitrectomy (index eye)
  • Previous retinal detachment (index eye)
Show all 11Show fewer
  • Previous or concurrent retina pathology (e.g. vascular)
  • Previous or concurrent macula pathology (macular hole, ERM, AMD, DME)
  • Anterior segment surgery within 3 months
  • Inability to maintain post intervention head positioning
  • Inability to carry out detailed examination of the peripheral retina due to media opacity NOTE: Lens/posterior hyaloid status does not impact eligibility.

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • St. Michael's Hospital Eye Clinic

    Toronto, Ontario, M5C2T2

    Rajeev Muni, MD Msc FRCSC, 4168677411

    Pamela Tan, 416 867 7411, pamela.tan@unityhealth.to

    Recruiting

Other trials in Canada

About this study

Official title: A Randomized controllEd Trial Comparing Pneumatic Retinopexy Versus Pars plAna Vitrectomy for the Management of Primary Retinal Detachment: Retinal Displacement Rates and Impact on Patient Quality of Life: The REVEAL Study

Patients may experience metamorphopsia, or image distortion, after having vitrectomy to repair their rhegmatogenous retinal detachments (RRDs) especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. There is no study in the scientific literature comparing the rate of retinal displacement and its association with visual function, including metamorphopsia, in patients undergoing different procedures for RRD repair. Based on the recently published PIVOT trial, patients who underwent Pneumatic Retinopexy (PnR) had less vertical distortion at 12 months than patients who had Pars Plana Vitrectomy (PPV). It is hypothesized that PnR will cause less retinal displacement than PPV for patients with macula-off primary retinal detachment.

Read the detailed description

Rhegmatogenous retinal detachments (RRD) are a sight-threatening condition with an incidence of approximately 10 per 100 000 people. RRDs can be broadly classified into those with the macula still attached, and those with the macula detached. Without surgical intervention by a vitreoretinal surgeon, retinal detachment almost invariably results in permanent sight loss. Current techniques for RRD repair include scleral buckle (SB), pneumatic retinopexy (PnR), and pars plana vitrectomy (PPV) with or without combination of SB.

Pneumatic retinopexy (PnR) is a minor surgical intervention employed to repair retinal detachments, carried out in the clinic's procedure room. Standard criteria for this procedure include one or more retinal breaks within one clock hour located at the superior eight clock hours, without signs of proliferative vitreoretinopathy. The procedure involves injection of a small gas bubble into the eyeball via a fine needle. Two gases can be injected into the eye: perfluoropropane (C3F8), which lasts 6 weeks, and sulfur hexafluoride (SF6), which lasts about 2 weeks. After injection of the gas bubble, the patient is required to maintain a strict 'head posture' (for example, head tilt to left) for up to 10 days. The gas bubble spontaneously dissipates after 2-6 weeks, depending on the gas selected. Additionally, laser treatment or cryotherapy is carried out either before or 1-2 days after injection of the gas bubble, to secure the retinal tear. The advantages of PnR over PPV are: (1) Low risk of cataract - secondary cataract formation is uncommon after PnR, but more common after PPV; (2) Quicker visual rehabilitation - due to the smaller size gas bubble and less invasive nature of the procedure, patients undergoing PnR commonly have improved vision within days after treatment; (3) Immediate availability of intervention - unlike PPV, PnR is carried out in a treatment room, and there are no delays due to operating room availability.

Pars plana vitrectomy (PPV) is a surgical procedure carried out in the operating room under regional anesthetic, and often times sedation. During PPV, the vitreous gel is removed from the eye to allow space for a larger gas bubble than is possible in PnR, and also to relieve any vitreous traction which may otherwise impair reattachment of the retina. The retina is reattached by either draining the subretinal fluid through a peripheral retinal break; by draining the subretinal fluid through a posterior retinotomy; or by using a heavier-than-water liquid such as perfluocarbon (PFC) to push out the subretinal fluid. Laser or cryotherapy is applied around the retinal tear to create chorioretinal adhesions (as in PnR). At the end of the surgery, the vitreous cavity is filled with a substance that will tamponade the retina to the wall of the eye while the adhesions form. Tamponade agents can be temporary, such as SF6 and C3F8 (same gases as mentioned for PnR), which are absorbed by 2-6 weeks, or long term, such as silicone oil, which requires a second surgery to remove. After the surgery, the patient may be required to maintain a 'head posture' (for example, head tilt to left) for up to one week to support the area of the retinal tear optimally by 'floating' the gas bubble up against it. As the gas bubble is larger in PPV, the head posturing requirements are less strict. The advantages of PPV over PnR are: (1) higher primary single procedure success rate (although same final reattachment success rate); (2) less follow-up visits in the first week.

Patients may experience metamorphopsia, or image distortion, after having their RRD repaired especially those with a detached macula. In 2010, Shiragami et al were the first to demonstrate hyperfluorescent lines, adjacent to the retinal blood vessels in Fundus autofluorescence imaging (FAF) of the retina after RD repair surgery.They theorized that these lines which are called Retinal Vessel Printings (RVP) correspond to the location of the retinal blood vessels before the retinal detachment. In FAF, an image is taken with structures that naturally fluoresce such as the lipofuscin in the retinal pigment epithelium (RPE) appearing brighter. According to this theory, prior to the retinal detachment, certain RPE cells were covered by the retinal blood vessels. Afterwards, with the displacement of the retina due to the retinal detachment these RPE cells become exposed to light which increases in metabolic activity producing more lipofuscin and therefore, appearing more hyperautofluorescent on the FAF. Moreover, these reference lines allow us to quantify the displacement of the retina after retinal detachment surgeries. In this study by Shiragami, 62.8% of eyes demonstrated hyperautofluorescent lines superior to the retinal blood vessels suggesting downward displacement. Since Shiragami's first report, several other studies looked into retinal displacement after RD repair.

There is no study in the scientific literature comparing the rate of retinal displacement and its association with visual function, including metamorphopsia, in patients undergoing different procedures for RRD repair.

The aim of this study is to compare retinal displacement following primary macula-off retinal detachment repair treated with pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV). The primary study hypothesis is that pneumatic retinopexy will cause less retinal displacement at 3 months for patients with macula-off primary retinal detachment.

Being tested
PnR + laser/cryotherapy, PPV + laser/cryotherapy
Medical subject headings
Retinal Detachment, Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PnR + laser/cryotherapyProcedure or surgery

    Pneumatic retinopexy plus laser/cryotherapy

  • PPV + laser/cryotherapyProcedure or surgery

    Pars plana vitrectomy plus laser/cryotherapy

Study groups in NCT04158622
Study groupRoleWhat they receive
Pneumatic RetinopexyExperimentalPatients with retinal detachment allocated to pneumatic retinopexy + laser/cryotherapy
Receives: Procedure: PnR + laser/cryotherapy
Pars Plana VitrectomyExperimentalPatients with retinal detachment allocated to pars plana vitrectomy + laser/cryotherapy
Receives: Procedure: PPV + laser/cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retinal Displacement

    Retinal displacement by the presence of retinal vessels printing on FAF imaging

    Measured: 3 months post intervention

Secondary outcomes (10)
  1. Visual acuity (ETDRS)

    The Early Treatment of Diabetic Retinopathy Study (ETDRS) developed a vision chart that has now become the gold standard for measuring visual function in ophthalmic research.

    Measured: 3, 6, and 12 months post intervention

  2. Objective Metamorphopsia

    Metamorphopsia assessed by M-CHARTS, which measures the minimum visual angle of a dotted line needed to detect metamorphopsia.

    Measured: 3, 6, and 12 months post intervention

  3. Subjective Metamorphopsia

    Metamorphopsia Questionnaire; The Questionnaire is a valid tool to assess patient's subjective perception of metamorphopsia. The minimum score is 0 and maximum score is 3, and higher scores mean a worse outcome.

    Measured: 3, 6, and 12 months post intervention

  4. Aniseikonia Test

    Aniseikonia Test measures the ratio of image size difference between the 2 eyes.

    Measured: 3, 6, and 12 months post intervention

  5. Optical Coherence Tomography (OCT) cystoid macular edema (CME)

    Two readers will analyze the cross-sectional OCT images regarding the presence of CME.

    Measured: 3, 6, and 12 months post intervention

  6. Optical Coherence Tomography (OCT) layers disruption

    Two readers will analyze the cross-sectional OCT images regarding the presence of retinal layers disruption.

    Measured: 3, 6, and 12 months post intervention

  7. Optical Coherence Tomography (OCT) retinal folds

    Two readers will analyze the cross-sectional OCT images regarding the presence of outer/inner retinal folds.

    Measured: 3, 6, and 12 months post intervention

  8. Optical Coherence Tomography Angiography (OCTA) capillary perfusion

    Two readers will analyze OCTA images regarding retinal capillary plexuses perfusion.

    Measured: 3, 6, and 12 months post intervention

  9. Optical Coherence Tomography Angiography (OCTA) changes

    Two readers will analyze OCTA images regarding area of foveal avascular zone.

    Measured: 3, 6, and 12 months post intervention

  10. Association between retinal displacement (RVP) and visual function (ETDRS)

    Association between the presence of retinal displacement and ETDRS values.

    Measured: 3 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2019
  2. Study start15 Mar 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Assignment
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04158622
Sponsor's protocol ID
19-239
Acronym
REVEAL
Status last verified
Apr 2021
First submitted
16 Oct 2019
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing PnR + laser/cryotherapy and PPV + laser/cryotherapy in people with Retinal Detachment and Metamorphopsia, run by Unity Health Toronto at 1 site in Canada.

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 11 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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. 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 Canada. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rajeev Muni, MD (416-867-7411, Rajeev.Muni@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retinal Displacement (time frame: 3 months post intervention). 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 28 Apr 2021.

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