Rhegmatogenous Retinal DetachmentNCT01639209
Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment
A study testing Vitrectomy and Pneumatic retinopexy in people with Rhegmatogenous Retinal Detachment, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Vitrectomy and Pneumatic retinopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2012to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Ophthalmology, St Michael's Hospital
Toronto, Ontario, M5C 2T2
About this study
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
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.
Read the 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.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Vitrectomy, Pneumatic retinopexy
- Keywords
- Retinal detachment, Pneumatic retinopexy, Vitrectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
Pars plana vitrectomy plus laser/cryotherapy
Pneumatic retinopexyProcedure or surgery
Pneumatic retinopexy plus laser/cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Vitrectomy | Experimental | Not described Receives: Procedure: Vitrectomy |
| Pneumatic retinopexy | Experimental | Not described Receives: Procedure: Pneumatic retinopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 12 months post intervention
Secondary outcomes (4)
Visual acuity
Measured: 1 week, 1 month, 3 months and 6 months post intervention
Subjective visual function
Questionnaire
Measured: 3, 6 and 12 months post intervention
Anatomical success (complete retinal re-attachment)
Measured: 3, 6 and 12 months post intervention
Subjective health related quality of life
Questionnaire
Measured: Baseline and 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajeev H Muni, FRCSC, Principal investigator, St. Michael's Hospital (Toronto, Canada)Roxane J Hillier, FRCOphth, Principal investigator, St. Michael's Hospital (Toronto, Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639209
- Sponsor's protocol ID
- REB #12-031
- Status last verified
- Sep 2019
- First submitted
- 9 Jul 2012
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
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. 2023 Nov;107(11):1693-1697. doi: 10.1136/bjo-2021-320981. Epub 2022 Aug 11.
PubMed 35953261Muni 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.
PubMed 33885738Muni 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.
PubMed 32556156
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01639209
- Acronym / sponsor ID
- REB #12-031
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Retinal detachment, Pneumatic retinopexy, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 12 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitrectomy | Experimental | Procedure: Vitrectomy |
| Pneumatic retinopexy | Experimental | Procedure: Pneumatic retinopexy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Inferior breaks in detached retina
- Inability to read English language
- Age < 18 years
- Mental incapacity
- Previous vitrectomy (index eye)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitrectomyPars plana vitrectomy plus laser/cryotherapy | Procedure or surgery | Vitrectomy |
| Pneumatic retinopexyPneumatic retinopexy plus laser/cryotherapy | Procedure or surgery | Pneumatic retinopexy |
Primary outcome
Visual acuity
Time frame: 12 months post intervention
4 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 35953261Bansal 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.
- Derived from this study: PubMed 33885738Muni 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.
- Derived from this study: PubMed 32556156Muni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeev H Muni, FRCSC principal investigator
St. Michael's Hospital (Toronto, Canada)
Roxane J Hillier, FRCOphth principal investigator
St. Michael's Hospital (Toronto, Canada)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitrectomy and Pneumatic retinopexy in people with Rhegmatogenous Retinal Detachment, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 12 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01639209, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019.