Clinical trial NCT01639209: Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment
Official title: A Randomised Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment; Anatomical Success, Functional Success and Impact on Patient Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Keywords: Retinal detachment
Pneumatic retinopexy
Vitrectomy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 176
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to compare the outcomes of pneumatic retinopexy with the outcomes of vitrectomy (with or without scleral buckle) for the management of retinal detachment, in terms of anatomical success, functional success and impact on patient quality of life.

Detailed description: Rhegmatogenous retinal detachment (RRD)is an acute, sight threatening condition, with an incidence of approximately 10 per 100,000 population. Both of the treatments under investigation are widely used and accepted by vitreoretinal surgeons, but randomised, prospective comparison of the two techniques has not been reported in the scientific literature to date. Currently, the management decisions surrounding primary retinal detachment are grounded on a weak evidence base. The findings of this study will allow vitreoretinal surgeons and their patients to select the most appropriate intervention for that individual, in an informed and holistic manner.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with acute rhegmatogenous retinal detachment
* Single retinal break OR group of breaks no larger than one clock hour (30°)
* All break/s in detached retina between 8-4 o'clock
* No significant proliferative vitreoretinopathy

Exclusion Criteria:

* Inferior breaks in detached retina
* Inability to read English language
* Age \< 18 years
* Mental incapacity
* Previous vitrectomy (index eye)
* Previous retinal detachment (index eye)
* Inability to maintain the post-operative posturing
* Inability to carry out detailed examination of peripheral retina due to media opacity

Primary outcomes:
measure: Visual acuity
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Visual acuity
timeFrame: 1 week, 1 month, 3 months and 6 months post intervention
measure: Subjective visual function
timeFrame: 3, 6 and 12 months post intervention
measure: Anatomical success (complete retinal re-attachment)
timeFrame: 3, 6 and 12 months post intervention
measure: Subjective health related quality of life
timeFrame: Baseline and 1 month post intervention
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Ophthalmology, St Michael's Hospital
state: Ontario
Study officials:
affiliation: St. Michael's Hospital (Toronto, Canada)
name: Rajeev H Muni, FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital (Toronto, Canada)
name: Roxane J Hillier, FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bansal A, Lee WW, Sarraf D, Sadda SR, Berger AR, Wong DT, Kertes PJ, Kohly RP, Hillier RJ, Muni RH. Persistent subfoveal fluid in pneumatic retinopexy versus pars plana vitrectomy for rhegmatogenous retinal detachment: posthoc analysis of the PIVOT randomised trial. Br J Ophthalmol. 2023 Nov;107(11):1693-1697. doi: 10.1136/bjo-2021-320981. Epub 2022 Aug 11.
citation: Muni RH, Felfeli T, Sadda SR, Juncal VR, Francisconi CLM, Nittala MG, Lindenberg S, Gunnemann F, Berger AR, Wong DT, Altomare F, Giavedoni LR, Kohly RP, Kertes PJ, Sarraf D, Hillier RJ. Postoperative Photoreceptor Integrity Following Pneumatic Retinopexy vs Pars Plana Vitrectomy for Retinal Detachment Repair: A Post Hoc Optical Coherence Tomography Analysis From the Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial. JAMA Ophthalmol. 2021 Jun 1;139(6):620-627. doi: 10.1001/jamaophthalmol.2021.0803.
citation: Muni RH, Francisconi CLM, Felfeli T, Mak MYK, Berger AR, Wong DT, Altomare F, Giavedoni LR, Kohly RP, Kertes PJ, Figueiredo N, Zuo F, Thorpe KE, Hillier RJ. Vision-Related Functioning in Patients Undergoing Pneumatic Retinopexy vs Vitrectomy for Primary Rhegmatogenous Retinal Detachment: A Post Hoc Exploratory Analysis of the PIVOT Randomized Clinical Trial. JAMA Ophthalmol. 2020 Aug 1;138(8):826-833. doi: 10.1001/jamaophthalmol.2020.2007.