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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitrectomy | Experimental |
| |
| Pneumatic retinopexy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitrectomy | Procedure | Pars plana vitrectomy plus laser/cryotherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | 12 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | 1 week, 1 month, 3 months and 6 months post intervention | |
| Subjective visual function | Questionnaire | 3, 6 and 12 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajeev H Muni, FRCSC | St. Michael's Hospital (Toronto, Canada) | Principal Investigator |
| Roxane J Hillier, FRCOphth | St. Michael's Hospital (Toronto, Canada) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, St Michael's Hospital | Toronto | Ontario | M5C 2T2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35953261 | Derived | 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. | |
| 33885738 |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Pneumatic retinopexy |
| Procedure |
Pneumatic retinopexy plus laser/cryotherapy |
|
| Anatomical success (complete retinal re-attachment) | 3, 6 and 12 months post intervention |
| Subjective health related quality of life | Questionnaire | Baseline and 1 month post intervention |
| 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. |
| 32556156 | Derived | 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. |