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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

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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Metamorphopsia Procedure: PnR + laser/cryotherapy Procedure: PPV + laser/cryotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pneumatic Retinopexy
Patients with retinal detachment allocated to pneumatic retinopexy + laser/cryotherapy
Procedure: PnR + laser/cryotherapy
Pneumatic retinopexy plus laser/cryotherapy

Experimental: Pars Plana Vitrectomy
Patients with retinal detachment allocated to pars plana vitrectomy + laser/cryotherapy
Procedure: PPV + laser/cryotherapy
Pars plana vitrectomy plus laser/cryotherapy




Primary Outcome Measures :
  1. Retinal Displacement [ Time Frame: 3 months post intervention ]
    Retinal displacement by the presence of retinal vessels printing on FAF imaging


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Aniseikonia Test [ Time Frame: 3, 6, and 12 months post intervention ]
    Aniseikonia Test measures the ratio of image size difference between the 2 eyes.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158622


Contacts
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Contact: Rajeev Muni, MD 416-867-7411 Rajeev.Muni@unityhealth.to
Contact: Philip To 416-867-7411 Philip.To@unityhealth.to

Locations
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Canada, Ontario
St. Michael's Hospital Eye Clinic Recruiting
Toronto, Ontario, Canada, M5C2T2
Contact: Rajeev Muni, MD Msc FRCSC    4168677411      
Contact: Phillip To    4168677411    top@smh.ca   
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Rajeev Muni, FRSCS St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT04158622    
Other Study ID Numbers: 19-239
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vision Disorders
Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms