NCT01639209

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

July 9, 2012

Last Update Submit

September 17, 2019

Conditions

Rhegmatogenous Retinal Detachment

Keywords

Retinal detachmentPneumatic retinopexyVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    12 months post intervention

Secondary Outcomes (4)

  • Visual acuity

    1 week, 1 month, 3 months and 6 months post intervention

  • Subjective visual function

    3, 6 and 12 months post intervention

  • Anatomical success (complete retinal re-attachment)

    3, 6 and 12 months post intervention

  • Subjective health related quality of life

    Baseline and 1 month post intervention

Study Arms (2)

Vitrectomy

EXPERIMENTAL
Procedure: Vitrectomy

Pneumatic retinopexy

EXPERIMENTAL
Procedure: Pneumatic retinopexy

Interventions

VitrectomyPROCEDURE

Pars plana vitrectomy plus laser/cryotherapy

Vitrectomy
Pneumatic retinopexyPROCEDURE

Pneumatic retinopexy plus laser/cryotherapy

Pneumatic retinopexy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, St Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (3)

  • 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.

    PMID: 35953261DERIVED

  • 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.

    PMID: 33885738DERIVED

  • 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.

    PMID: 32556156DERIVED

MeSH Terms

Conditions

Retinal Detachment

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Rajeev H Muni, FRCSC

    St. Michael's Hospital (Toronto, Canada)

    PRINCIPAL INVESTIGATOR

  • Roxane J Hillier, FRCOphth

    St. Michael's Hospital (Toronto, Canada)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 12, 2012

Study Start

August 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

CA(1)