Recruiting

Pneumatic Retinopexy vs. Pars Plana Vitrectomy

Sponsor:

Unity Health Toronto

Code:

NCT04158622

Conditions

Retinal Detachment

Metamorphopsia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PnR + laser/cryotherapy

PPV + laser/cryotherapy

Study Details

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

Study ID

NCT04158622

Start date

Mar 15, 2021

Status verified date

Apr, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Pneumatic Retinopexy

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

experimental: Pars Plana Vitrectomy

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

Interventions

PnR + laser/cryotherapy

Pneumatic retinopexy plus laser/cryotherapy

PPV + laser/cryotherapy

Pars plana vitrectomy plus laser/cryotherapy

Primary outcome measure

  • Retinal Displacement [ Time Frame: 3 months post intervention ]

Central Contacts and Locations

Central contacts

Rajeev Muni, MD

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

Philip To

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

Locations

St. Michael's Hospital Eye Clinic

Recruiting

Toronto, Ontario, Canada, M5C2T2

Contacts

Rajeev Muni, MD Msc FRCSC

4168677411

Pamela Tan

416 867 7411pamela.tan@unityhealth.to

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 28, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2021-04-28.