Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment
NCT ID: NCT01639209
Last Updated: 2019-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2012-08-31
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vitrectomy
Vitrectomy
Pars plana vitrectomy plus laser/cryotherapy
Pneumatic retinopexy
Pneumatic retinopexy
Pneumatic retinopexy plus laser/cryotherapy
Interventions
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Vitrectomy
Pars plana vitrectomy plus laser/cryotherapy
Pneumatic retinopexy
Pneumatic retinopexy plus laser/cryotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Rajeev H Muni, FRCSC
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital (Toronto, Canada)
Roxane J Hillier, FRCOphth
Role: PRINCIPAL_INVESTIGATOR
St. Michael's Hospital (Toronto, Canada)
Locations
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Department of Ophthalmology, St Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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.
Other Identifiers
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REB #12-031
Identifier Type: -
Identifier Source: org_study_id
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