Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

• ClinicalTrials.gov Identifier: NCT01639209
• Recruitment Status: Completed
• First Posted: July 12, 2012
• Last Update Posted: September 18, 2019
• Sponsor: Unity Health Toronto
• Information provided by (Responsible Party): Unity Health Toronto

Tracking Information

• First Submitted Date: July 9, 2012
• First Posted Date: July 12, 2012
• Last Update Posted Date: September 18, 2019
• Actual Study Start Date: August 2012
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 11, 2012): Visual acuity [ Time Frame: 12 months post intervention ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 30, 2012)

• Visual acuity [ Time Frame: 1 week, 1 month, 3 months and 6 months post intervention ]
• Subjective visual function [ Time Frame: 3, 6 and 12 months post intervention ]
  Questionnaire
• Anatomical success (complete retinal re-attachment) [ Time Frame: 3, 6 and 12 months post intervention ]
• Subjective health related quality of life [ Time Frame: Baseline and 1 month post intervention ]
  Questionnaire

Original Secondary Outcome Measures (submitted: July 11, 2012)

• Visual acuity [ Time Frame: 1 week, 1 month and 3 months post intervention ]
• Subjective visual function [ Time Frame: 3 and 12 months post intervention ]
  Questionnaire
• Anatomical success (complete retinal re-attachment) [ Time Frame: 3 and 12 months post intervention ]
• Subjective health related quality of life [ Time Frame: Baseline and 1 month post intervention ]
  Questionnaire

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rhegmatogenous Retinal Detachment

Intervention

• Procedure: Vitrectomy
  Pars plana vitrectomy plus laser/cryotherapy
• Procedure: Pneumatic retinopexy
  Pneumatic retinopexy plus laser/cryotherapy

Study Arms

• Experimental: Vitrectomy
  Intervention: Procedure: Vitrectomy
• Experimental: Pneumatic retinopexy
  Intervention: Procedure: Pneumatic retinopexy

Publications *

• 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. 2022 Aug 11:bjophthalmol-2021-320981. doi: 10.1136/bjo-2021-320981. Online ahead of print.
• 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. Erratum In: JAMA Ophthalmol. 2021 Jun 1;139(6):679.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 11, 2012): 176
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2017
• Actual Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01639209
• Other Study ID Numbers: REB #12-031
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Unity Health Toronto
• Original Responsible Party: Same as current
• Current Study Sponsor: Unity Health Toronto
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rajeev H Muni, FRCSC; St. Michael's Hospital (Toronto, Canada)
• Principal Investigator: Roxane J Hillier, FRCOphth; St. Michael's Hospital (Toronto, Canada)

• PRS Account: Unity Health Toronto
• Verification Date: September 2019