Rhegmatogenous Retinal Detachment Clinical Trial
Official title:
A Randomized Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment in Patients With Extended Criteria; Anatomical Success, Functional Success and Impact on Patient Quality of Life
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.
n/a
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