Clinical Trial: Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment in Patients With Extended Criteria; Anatomi

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 mon

Detailed Summary:
Sponsor: St. Michael's Hospital, Toronto

Current Primary Outcome: Visual acuity (ETDRS) [ Time Frame: 12 months post intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual acuity (ETDRS) [ Time Frame: 3, 6 and 24 months post intervention ]
  • Visual acuity (Snellen) [ Time Frame: 1 week, 1, 3, 6, 12 and 24 months post intervention ]
  • Subjective visual function (VFQ25) [ Time Frame: 3, 6, 12 and 24 months post intervention ]
  • Anatomical success (complete retinal re-attachment with no adjuvant surgical procedure) [ Time Frame: 3, 6, 12 and 24 months post intervention ]
  • Subjective health related quality of life (SF-36v2) [ Time Frame: baseline, 1 month, 12 and 24 months post intervention ]


Original Secondary Outcome: Same as current

Information By: St. Michael's Hospital, Toronto

Dates:
Date Received: August 11, 2016
Date Started: November 2016
Date Completion:
Last Updated: August 15, 2016
Last Verified: August 2016