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

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ClinicalTrials.gov Identifier: NCT04158622
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE October 16, 2019
First Posted Date  ICMJE November 12, 2019
Last Update Posted Date March 24, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
Retinal Displacement [ Time Frame: 3 months post intervention ]
Retinal displacement by the presence of retinal vessels printing on FAF imaging
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
  • Visual acuity (ETDRS) [ Time Frame: 3, 6, and 12 months post intervention ]
    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.
  • Objective Metamorphopsia [ Time Frame: 3, 6, and 12 months post intervention ]
    Metamorphopsia assessed by M-CHARTS, which measures the minimum visual angle of a dotted line needed to detect metamorphopsia.
  • Subjective Metamorphopsia [ Time Frame: 3, 6, and 12 months post intervention ]
    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.
  • Aniseikonia Test [ Time Frame: 3, 6, and 12 months post intervention ]
    Aniseikonia Test measures the ratio of image size difference between the 2 eyes.
  • Optical Coherence Tomography (OCT) cystoid macular edema (CME) [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze the cross-sectional OCT images regarding the presence of CME.
  • Optical Coherence Tomography (OCT) layers disruption [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze the cross-sectional OCT images regarding the presence of retinal layers disruption.
  • Optical Coherence Tomography (OCT) retinal folds [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze the cross-sectional OCT images regarding the presence of outer/inner retinal folds.
  • Optical Coherence Tomography Angiography (OCTA) capillary perfusion [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze OCTA images regarding retinal capillary plexuses perfusion.
  • Optical Coherence Tomography Angiography (OCTA) changes [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze OCTA images regarding area of foveal avascular zone.
  • Association between retinal displacement (RVP) and visual function (ETDRS) [ Time Frame: 3 months post intervention ]
    Association between the presence of retinal displacement and ETDRS values.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • Visual acuity (ETDRS) [ Time Frame: 3, 6, and 12 months post intervention ]
    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.
  • Objective Metamorphopsia [ Time Frame: 3, 6, and 12 months post intervention ]
    Metamorphopsia assessed by M-CHARTS, which measures the minimum visual angle of a dotted line needed to detect metamorphopsia.
  • Subjective Metamorphopsia [ Time Frame: 3, 6, and 12 months post intervention ]
    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.
  • Aniseikonia Test [ Time Frame: 3, 6, and 12 months post intervention ]
    Aniseikonia Test measures the ratio of image size difference between the 2 eyes.
  • Optical Coherence Tomography (OCT) cystoid macular edema (CME) [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze the cross-sectional OCT images regarding the presence of CME.
  • Optical Coherence Tomography (OCT) layers disruption [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze the cross-sectional OCT images regarding the presence of retinal layers disruption.
  • Optical Coherence Tomography (OCT) retinal folds [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze the cross-sectional OCT images regarding the presence of outer/inner retinal folds.
  • Optical Coherence Tomography Angiography (OCTA) capillary perfusion [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze OCTA images regarding retinal capillary plexuses perfusion.
  • Optical Coherence Tomography Angiography (OCTA) changes [ Time Frame: 3, 6, and 12 months post intervention ]
    Two readers will analyze OCTA images regarding area of foveal avascular zone.
  • Association between retinal displacement and visual function [ Time Frame: 3 months post intervention ]
    Association between the presence of RVP in FAF and ETDRS values.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retinal Displacement Rates in Pneumatic Retinopexy Versus Pars Plana Vitrectomy For Primary Retinal Detachment
Official Title  ICMJE 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
Brief 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. 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Retinal Detachment
  • Metamorphopsia
Intervention  ICMJE
  • Procedure: PnR + laser/cryotherapy
    Pneumatic retinopexy plus laser/cryotherapy
  • Procedure: PPV + laser/cryotherapy
    Pars plana vitrectomy plus laser/cryotherapy
Study Arms  ICMJE
  • Experimental: Pneumatic Retinopexy
    Patients with retinal detachment allocated to pneumatic retinopexy + laser/cryotherapy
    Intervention: Procedure: PnR + laser/cryotherapy
  • Experimental: Pars Plana Vitrectomy
    Patients with retinal detachment allocated to pars plana vitrectomy + laser/cryotherapy
    Intervention: Procedure: PPV + laser/cryotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 6, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rajeev Muni, MD 416-867-7411 Rajeev.Muni@unityhealth.to
Contact: Philip To 416-867-7411 Philip.To@unityhealth.to
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04158622
Other Study ID Numbers  ICMJE 19-239
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajeev Muni, FRSCS St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP