Rhegmatogenous Retinal DetachmentNCT04723420
Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
A study testing Steamroller technique and Direct technique in people with Rhegmatogenous Retinal Detachment, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This is a randomized controlled trial comparing displacement of macula and the rapidity of reattachment of macula between two different positioning techniques after pneumatic retinopexy : Direct technique (patient is positioned so that the bubble is immediately placed directly over the retina break) and Steamroller… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- What is being tested?
- Steamroller technique and Direct technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 7 Aug 2020to 7 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary RRD
- Causative breaks over superior 8 clock hours
- Single break or group of breaks
- No or min proliferative vitreoretinopathy (PVR) (Grade A or B)
- Other breaks or lattice in attached retina are allowed
Who cannot join
- Retinal break in the inferior 4 clock hours in detached retina
- PVR Grade C or worse
- Significant media opacity (Vitreous hemorrhage, dense cataract, cornea scar, etc)
- Pre-existing ocular pathology [macula hole (MH), epiretinal membrane (ERM), cystoid macula edema (CME), age-related macula degeneration, myopic degeneration, advanced glaucoma, uveitis, amblyopia etc] or previous eye trauma with poor baseline vision
- Previous pars plana vitrectomy
- Age ≤18years old
- Inadequate physical or mental competence to maintain the required postoperative head position
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Kenneth Eng, MD FRCSC, 416-480-4688, kenneth.eng@sunnybrook.ca
Kenneth Eng, MD FRCSC
About this study
This is a randomized controlled trial comparing displacement of macula and the rapidity of reattachment of macula between two different positioning techniques after pneumatic retinopexy : Direct technique (patient is positioned so that the bubble is immediately placed directly over the retina break) and Steamroller technique (patient is initially positioned face down for 4-6 hours and subsequently changes their head position so that the bubble is then placed directly over the retina break).
Read the detailed description
Pneumatic retinopexy (PR) is an established treatment for rhegmatogenous retinal detachment (RRD). In our centre, PR is the most commonly performed procedure for primary RRD repair with a high retinal reattachment success rate. In this procedure, patients are required to position according to the site of pathology following injection of an intravitreal gas bubble. Some practitioners position the patient so that the gas bubble is immediately apposed directly against the retinal break (direct technique). Others favour the steamroller technique whereby the patient is initially positioned face down, then after 4-6 hours, the position is changed sequentially so that the bubble is rolled over the retina towards the break responsible for the detachment (steamroller technique). Variable visual acuity (VA) outcomes and metamorphopsia are common post-procedure complaints despite successful RRD repair with PR. It has been suggested that variability in functional outcomes may be associated with the timing and ease of reattachment of macula. The purpose of this prospective study is to evaluate whether the steamroller technique is superior to the direct technique in faster reattachment of macula with less macula displacement.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Steamroller technique, Direct technique
- Keywords
- Pneumatic Retinopexy, Steamroll, Direct to break
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steamroller techniqueOther
Following intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break.
Direct techniqueOther
Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.
| Study group | Role | What they receive |
|---|---|---|
| Steamroller Technique | Active comparator | Following intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break. Receives: Other: Steamroller technique |
| Direct Technique | Active comparator | Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break. Receives: Other: Direct technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular status at Day 1
Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula
Measured: 24hours post intervention
Secondary outcomes (5)
Anatomical displacement of macula and its changes with time.
Measurement of retinal vessel imprinting on fundus autofluorescence
Measured: 1,2, 3 and 6 months post intervention
Functional displacement of macula and its changes with time.
Measurement of metamorphopsia with M-charts
Measured: 1,2, 3 and 6 months post intervention
Macular Status
Looking at macula status via optical coherence tomography after intervention to see which technique is more effective in reattaching the macula early
Measured: 1hour, 2hours, Day 2, Week 1, Week 2
Visual acuity
ETDRS
Measured: 1, 3 and 6 months post intervention
Primary anatomical success
Complete reattachment of retina via clinical fundus examination and optos fundus photography
Measured: 1, 3 and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start7 Aug 2020
- Primary completion7 Dec 2023 (estimated)
- Study completion7 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kenneth Eng, Sunnybrook Health Sciences Centre
- Investigators
- Kenneth Eng, MD FRCSC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723420
- Sponsor's protocol ID
- 270-2019
- Status last verified
- Apr 2023
- First submitted
- 19 Dec 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not
- ClinicalTrials.gov ID
- NCT04723420
- Acronym / sponsor ID
- 270-2019
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- Pneumatic Retinopexy, Steamroll, Direct to break
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 7 Dec 2023 (estimated)
- Study completion
- 7 Dec 2023 (estimated)
- First posted
- 25 Jan 2021 (actual)
- 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.
This is a randomized controlled trial comparing displacement of macula and the rapidity of reattachment of macula between two different positioning techniques after pneumatic retinopexy : Direct technique (patient is positioned so that the bubble is immediately placed directly over the retina break) and Steamroller technique (patient is initially positioned face down for 4-6 hours and subsequently changes their head position so that the bubble is then placed directly over the retina break).
Detailed description
Pneumatic retinopexy (PR) is an established treatment for rhegmatogenous retinal detachment (RRD). In our centre, PR is the most commonly performed procedure for primary RRD repair with a high retinal reattachment success rate. In this procedure, patients are required to position according to the site of pathology following injection of an intravitreal gas bubble. Some practitioners position the patient so that the gas bubble is immediately apposed directly against the retinal break (direct technique). Others favour the steamroller technique whereby the patient is initially positioned face down, then after 4-6 hours, the position is changed sequentially so that the bubble is rolled over the retina towards the break responsible for the detachment (steamroller technique). Variable visual acuity (VA) outcomes and metamorphopsia are common post-procedure complaints despite successful RRD repair with PR. It has been suggested that variability in functional outcomes may be associated with the timing and ease of reattachment of macula. The purpose of this prospective study is to evaluate whether the steamroller technique is superior to the direct technique in faster reattachment of macula with less macula displacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steamroller Technique | Active comparator | Other: Steamroller techniqueFollowing intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break. |
| Direct Technique | Active comparator | Other: Direct techniqueFollowing intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary RRD
- Causative breaks over superior 8 clock hours
- Single break or group of breaks
- No or min proliferative vitreoretinopathy (PVR) (Grade A or B)
- Other breaks or lattice in attached retina are allowed
Key exclusion criteria (7 listed)
- Retinal break in the inferior 4 clock hours in detached retina
- PVR Grade C or worse
- Significant media opacity (Vitreous hemorrhage, dense cataract, cornea scar, etc)
- Pre-existing ocular pathology [macula hole (MH), epiretinal membrane (ERM), cystoid macula edema (CME), age-related macula degeneration, myopic degeneration, advanced glaucoma, uveitis, amblyopia etc] or previous eye trauma with poor baseline vision
- Previous pars plana vitrectomy
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 |
|---|---|---|
| Steamroller techniqueFollowing intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break. | Other | Steamroller Technique |
| Direct techniqueFollowing intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break. | Other | Direct Technique |
Primary outcome
Macular status at Day 1
Time frame: 24hours post intervention
Assessment of macular status by optical coherence tomography at 24 hours after intervention to see which technique is most effective for reattaching the macula
5 secondary outcomes
Anatomical displacement of macula and its changes with time.
Time frame: 1,2, 3 and 6 months post intervention
Functional displacement of macula and its changes with time.
Time frame: 1,2, 3 and 6 months post intervention
Macular Status
Time frame: 1hour, 2hours, Day 2, Week 1, Week 2
Visual acuity
Time frame: 1, 3 and 6 months post intervention
Primary anatomical success
Time frame: 1, 3 and 6 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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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.
Kenneth Eng, MD FRCSC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steamroller technique and Direct technique in people with Rhegmatogenous Retinal Detachment, run by Sunnybrook Health Sciences Centre 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (416-480-5091, Cindy.Rutz@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular status at Day 1 (time frame: 24hours post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2023.