Clinical trial NCT02871531: Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Keywords: retinal detachment
pneumatic retinopexy
vitrectomy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2016-08-18
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual acuity (ETDRS)
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Visual acuity (ETDRS)
timeFrame: 3, 6 and 24 months post intervention
measure: Visual acuity (Snellen)
timeFrame: 1 week, 1, 3, 6, 12 and 24 months post intervention
measure: Subjective visual function (VFQ25)
timeFrame: 3, 6, 12 and 24 months post intervention
measure: Anatomical success (complete retinal re-attachment with no adjuvant surgical procedure)
timeFrame: 3, 6, 12 and 24 months post intervention
measure: Subjective health related quality of life (SF-36v2)
timeFrame: baseline, 1 month, 12 and 24 months post intervention
measure: Aniseikonia rates
timeFrame: 12 and 24 months
measure: Metamorphopsia rates
timeFrame: 3, 12 and 24 months
measure: Retinal displacement rate measured with fundus autofluorescence
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital Eye Clinic
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
Study officials:
affiliation: staff
name: Rajeev Muni, FRSCS
role: PRINCIPAL_INVESTIGATOR
affiliation: research fellow
name: Verena Juncal, MD
role: PRINCIPAL_INVESTIGATOR
References: