Recruiting

Pneumatic Retinopexy vs. Vitrectomy

Sponsor:

Unity Health Toronto

Code:

NCT02871531

Conditions

Rhegmatogenous Retinal Detachment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pneumatic retinopexy

Vitrectomy

Study Details

Brief summary:

Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and patient quality of life in patients with extended criteria.

Methods: A prospective, randomized, controlled trial will be conducted with 178 patients presenting at St. Michael's Hospital with primary retinal detachment (RD). Inclusion criteria include: a single or multiple retinal tears in detached retina between 7 and 5 o'clock being of any size and any distance apart from each other, including giant retinal tears with inferior aspect above 5 and 7 o'clock, RD with no identifiable tear but where suspected tear is between 7 and 5 o'clock, retinoschisis with RD if tears are located between 7 and 5 o'clock, mild proliferative vitreoretinopathy, none or mild vitreous hemorrhage. Patients will be excluded if there is a small retinal tear or multiple tears less than 30o apart between 8 and 4 o'clock in detached retina, retinal tear in detached retina between 5 and 7 o'clock, <18 years old, inability to read English, mental incapacity, previous history of RD, scleral buckle or vitrectomy in index eye, inability to maintain appropriate head posture at post-operative period and inability to visualize peripheral retinal due to media opacity. Patients will be randomly allocated into two groups: PnR + cryotherapy/laser or vitrectomy + cryotherapy/laser and the intervention will take place within 24 hours and 72 hours for attached and detached macula status, respectively. Patients will undergo a complete ophthalmological examination, including visual acuity and fundus assessment at baseline and at 3, 6 and 12 months after surgery. Visual acuity will also be measured at 1, 7 and 30 days after surgery. Global health related quality of life will be evaluated with the SF-36v2 questionnaire at baseline, 1 month, 1 and 2 years after intervention, while the VFG25 questionnaire will be applied at 3, 6, 12 and 24 months after surgery to measure vision related quality of life.

Conditions

Rhegmatogenous Retinal Detachment

Study ID

NCT02871531

Start date

Nov, 2016

Status verified date

Aug, 2019

Completion date

Nov, 2023

Anticipated

Primary completion date

Nov, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Single retinal tear or group of tears (any distance apart) in detached retina located between 7 and 5 o'clock.
  • Retinal detachment with no identifiable tear but where suspected tear is located between 7-5 o'clock based on Lincoff rules
  • Any size of retinal tear, including giant retinal tears, if the inferior aspect of it is above 5 and 7 o'clock
  • Retinoschisis with retinal detachment if tears are located between 7 and 5 o'clock
  • There may be mild proliferative vitreoretinopathy (unless there is a visible traction on the break)
  • None or mild vitreous hemorrhage. Note: vitreous hemorrhage will be considered mild if it does not impair an adequate examination of the retinal periphery.
  • In the opinion of the investigator, PnR is likely to achieve anatomical re-attachment of the retina

Exclusion Criteria:

  • Group of tears <30o apart in detached retina if all located within 8-4 o'clock
  • Single retinal tear smaller than 1 o'clock in detached retina between 8-4 o'clock
  • Retinal tears below the 5 and 7 o'clock meridian in detached retina (note that additional tears in attached retina are acceptable)
  • Inability to read English language
  • Age <18 years
  • Mental incapacity
  • Previous vitrectomy or scleral buckle (index eye)
  • Previous retinal detachment (index eye)
  • Inability to maintain the strict post-operative posturing requirements of pneumatic retinopexy
  • Inability to carry out detailed examination of the peripheral retina due to media opacity NOTE: Lens/posterior hyaloid status does not affect eligibility.

Study Design

Enrollment

178 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pneumatic retinopexy

Patients with retinal detachment allocated to pneumatic retinopexy

experimental: Vitrectomy

Patients with retinal detachment allocated to vitrectomy

Interventions

Pneumatic retinopexy

Vitrectomy

Primary outcome measure

  • Visual acuity (ETDRS) [ Time Frame: 12 months post intervention ]

Central Contacts and Locations

Locations

St. Michael's Hospital Eye Clinic

Recruiting

Toronto, Ontario, Canada, M5C2T2

Contacts

Rajeev Muni, MD Msc FRCSC

4168677411

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Canada

More Information

Sponsor

Unity Health Toronto

Last update posted

Aug 26, 2019

Last verified

Aug, 2019

Keywords

  • retinal detachment
  • pneumatic retinopexy
  • vitrectomy

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 2019-08-26.