Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment

NCT ID: NCT01639209

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rhegmatogenous Retinal Detachment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitrectomy

Group Type EXPERIMENTAL

Vitrectomy

Intervention Type PROCEDURE

Pars plana vitrectomy plus laser/cryotherapy

Pneumatic retinopexy

Group Type EXPERIMENTAL

Pneumatic retinopexy

Intervention Type PROCEDURE

Pneumatic retinopexy plus laser/cryotherapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitrectomy

Pars plana vitrectomy plus laser/cryotherapy

Intervention Type PROCEDURE

Pneumatic retinopexy

Pneumatic retinopexy plus laser/cryotherapy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, St Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35953261 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33885738 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32556156 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REB #12-031

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Small Macular Holes Treated With Air
NCT06211907 RECRUITING NA
REtinal Detachment Outcomes Study
NCT05863312 RECRUITING NA