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Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

Primary Purpose

Rhegmatogenous Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vitrectomy
Pneumatic retinopexy
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring Retinal detachment, Pneumatic retinopexy, Vitrectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, St Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vitrectomy

Pneumatic retinopexy

Arm Description

Outcomes

Primary Outcome Measures

Visual acuity

Secondary Outcome Measures

Visual acuity
Subjective visual function
Questionnaire
Anatomical success (complete retinal re-attachment)
Subjective health related quality of life
Questionnaire

Full Information

First Posted
July 9, 2012
Last Updated
September 17, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01639209
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment
Keywords
Retinal detachment, Pneumatic retinopexy, Vitrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitrectomy
Arm Type
Experimental
Arm Title
Pneumatic retinopexy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Intervention Description
Pars plana vitrectomy plus laser/cryotherapy
Intervention Type
Procedure
Intervention Name(s)
Pneumatic retinopexy
Intervention Description
Pneumatic retinopexy plus laser/cryotherapy
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
12 months post intervention
Secondary Outcome Measure Information:
Title
Visual acuity
Time Frame
1 week, 1 month, 3 months and 6 months post intervention
Title
Subjective visual function
Description
Questionnaire
Time Frame
3, 6 and 12 months post intervention
Title
Anatomical success (complete retinal re-attachment)
Time Frame
3, 6 and 12 months post intervention
Title
Subjective health related quality of life
Description
Questionnaire
Time Frame
Baseline and 1 month post intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajeev H Muni, FRCSC
Organizational Affiliation
St. Michael's Hospital (Toronto, Canada)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roxane J Hillier, FRCOphth
Organizational Affiliation
St. Michael's Hospital (Toronto, Canada)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, St Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35953261
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. 2022 Aug 11:bjophthalmol-2021-320981. doi: 10.1136/bjo-2021-320981. Online ahead of print.
Results Reference
derived
PubMed Identifier
33885738
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. Erratum In: JAMA Ophthalmol. 2021 Jun 1;139(6):679.
Results Reference
derived
PubMed Identifier
32556156
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.
Results Reference
derived

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Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

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