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

NCT04158622 | Unknown

• 1 other identifier: 19-239
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Detachment; Metamorphopsia

Outcome Measures

Primary Outcomes (1)

• Retinal Displacement

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

  3 months post intervention

Secondary Outcomes (10)

• Visual acuity (ETDRS)

  3, 6, and 12 months post intervention

• Objective Metamorphopsia

  3, 6, and 12 months post intervention

• Subjective Metamorphopsia

  3, 6, and 12 months post intervention

• Aniseikonia Test

  3, 6, and 12 months post intervention

• Optical Coherence Tomography (OCT) cystoid macular edema (CME)

  3, 6, and 12 months post intervention

Study Arms (2)

Pneumatic Retinopexy

EXPERIMENTAL

Patients with retinal detachment allocated to pneumatic retinopexy + laser/cryotherapy

Procedure: PnR + laser/cryotherapy

Pars Plana Vitrectomy

EXPERIMENTAL

Patients with retinal detachment allocated to pars plana vitrectomy + laser/cryotherapy

Procedure: PPV + laser/cryotherapy

Interventions

PnR + laser/cryotherapy PROCEDURE

Pneumatic retinopexy plus laser/cryotherapy

Pneumatic Retinopexy

PPV + laser/cryotherapy PROCEDURE

Pars plana vitrectomy plus laser/cryotherapy

Pars Plana Vitrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital Eye Clinic

Toronto, Ontario, M5C2T2, Canada

RECRUITING

MeSH Terms

Conditions

Retinal Detachment; Vision Disorders

Interventions

Lasers; Cryotherapy; Predictive Value of Tests

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies; Therapeutics; Sensitivity and Specificity; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rajeev Muni, FRSCS

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rajeev Muni, MD

CONTACT

416-867-7411; Rajeev.Muni@unityhealth.to

Philip To

CONTACT

416-867-7411; Philip.To@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Assignment

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 12, 2019
• Study Start: March 15, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)