Rhegmatogenous Retinal DetachmentNCT02871531
Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria
A study testing Pneumatic retinopexy and Vitrectomy in people with Rhegmatogenous Retinal Detachment, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and patient quality of life in patients with extended criteria. 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?
- Pneumatic retinopexy and Vitrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2016to Nov 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
- Single retinal tear or group of tears (any distance apart) in detached retina located between 7 and 5 o'clock.
- Retinal detachment with no identifiable tear but where suspected tear is located between 7-5 o'clock based on Lincoff rules
- Any size of retinal tear, including giant retinal tears, if the inferior aspect of it is above 5 and 7 o'clock
- Retinoschisis with retinal detachment if tears are located between 7 and 5 o'clock
- There may be mild proliferative vitreoretinopathy (unless there is a visible traction on the break)
- None or mild vitreous hemorrhage. Note: vitreous hemorrhage will be considered mild if it does not impair an adequate examination of the retinal periphery.
- In the opinion of the investigator, PnR is likely to achieve anatomical re-attachment of the retina
Who cannot join
- Group of tears <30o apart in detached retina if all located within 8-4 o'clock
- Single retinal tear smaller than 1 o'clock in detached retina between 8-4 o'clock
- Retinal tears below the 5 and 7 o'clock meridian in detached retina (note that additional tears in attached retina are acceptable)
- Inability to read English language
- Age <18 years
- Mental incapacity
Show all 10Show fewer
- Previous vitrectomy or scleral buckle (index eye)
- Previous retinal detachment (index eye)
- Inability to maintain the strict post-operative posturing requirements of pneumatic retinopexy
- Inability to carry out detailed examination of the peripheral retina due to media opacity NOTE: Lens/posterior hyaloid status does not affect eligibility.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
St. Michael's Hospital Eye Clinic
Toronto, Ontario, M5C2T2
Rajeev Muni, MD Msc FRCSC, 4168677411
Phillip To, 4168677411, top@smh.ca
- Recruiting
Sunnybrook Health Sciences Centre
Toronto
Peter Kertes
About this study
Official title: A Randomized Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment in Patients With Extended Criteria; Anatomical Success, Functional Success and Impact on Patient Quality of Life
Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and patient quality of life in patients with extended criteria.
Methods: A prospective, randomized, controlled trial will be conducted with 178 patients presenting at St. Michael's Hospital with primary retinal detachment (RD). Inclusion criteria include: a single or multiple retinal tears in detached retina between 7 and 5 o'clock being of any size and any distance apart from each other, including giant retinal tears with inferior aspect above 5 and 7 o'clock, RD with no identifiable tear but where suspected tear is between 7 and 5 o'clock, retinoschisis with RD if tears are located between 7 and 5 o'clock, mild proliferative vitreoretinopathy, none or mild vitreous hemorrhage. Patients will be excluded if there is a small retinal tear or multiple tears less than 30o apart between 8 and 4 o'clock in detached retina, retinal tear in detached retina between 5 and 7 o'clock, <18 years old, inability to read English, mental incapacity, previous history of RD, scleral buckle or vitrectomy in index eye, inability to maintain appropriate head posture at post-operative period and inability to visualize peripheral retinal due to media opacity. Patients will be randomly allocated into two groups: PnR + cryotherapy/laser or vitrectomy + cryotherapy/laser and the intervention will take place within 24 hours and 72 hours for attached and detached macula status, respectively. Patients will undergo a complete ophthalmological examination, including visual acuity and fundus assessment at baseline and at 3, 6 and 12 months after surgery. Visual acuity will also be measured at 1, 7 and 30 days after surgery. Global health related quality of life will be evaluated with the SF-36v2 questionnaire at baseline, 1 month, 1 and 2 years after intervention, while the VFG25 questionnaire will be applied at 3, 6, 12 and 24 months after surgery to measure vision related quality of life.
- Conditions
- Rhegmatogenous Retinal Detachment
- Being tested
- Pneumatic retinopexy, Vitrectomy
- 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.
Pneumatic retinopexyProcedure or surgery
Also called Pneumatic retinopexy plus laser/cryotherapy
VitrectomyProcedure or surgery
Also called Pars plana vitrectomy plus laser/cryotherapy
| Study group | Role | What they receive |
|---|---|---|
| Pneumatic retinopexy | Experimental | Patients with retinal detachment allocated to pneumatic retinopexy Receives: Procedure: Pneumatic retinopexy |
| Vitrectomy | Experimental | Patients with retinal detachment allocated to vitrectomy Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (ETDRS)
Measured: 12 months post intervention
Secondary outcomes (8)
Visual acuity (ETDRS)
Measured: 3, 6 and 24 months post intervention
Visual acuity (Snellen)
Measured: 1 week, 1, 3, 6, 12 and 24 months post intervention
Subjective visual function (VFQ25)
Measured: 3, 6, 12 and 24 months post intervention
Anatomical success (complete retinal re-attachment with no adjuvant surgical procedure)
Measured: 3, 6, 12 and 24 months post intervention
Subjective health related quality of life (SF-36v2)
Measured: baseline, 1 month, 12 and 24 months post intervention
Aniseikonia rates
Measured: 12 and 24 months
Metamorphopsia rates
Measured: 3, 12 and 24 months
Retinal displacement rate measured with fundus autofluorescence
Measured: 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2021 (estimated)
- Study completionNov 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 Unity Health TorontoThe 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
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajeev Muni, FRSCS, Principal investigator, staffVerena Juncal, MD, Principal investigator, research fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871531
- Sponsor's protocol ID
- Extended criteria pneumaticPPV
- Status last verified
- Aug 2019
- First submitted
- 11 Aug 2016
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Pneumatic Retinopexy Versus Vitrectomy for the Management of Primary Retinal Detachment in Patients With Extended Criteria; Anatomical Success, Functional Success and Impact on Patient Quality of Life
- ClinicalTrials.gov ID
- NCT02871531
- Acronym / sponsor ID
- Extended criteria pneumaticPPV
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- retinal detachment, pneumatic retinopexy, vitrectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 18 Aug 2016 (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.
Objective: To compare outcomes of retinal detachment repair following pneumatic retinopexy (PnR) versus pars plana vitrectomy in terms of anatomical success, functional success and patient quality of life in patients with extended criteria.
Methods: A prospective, randomized, controlled trial will be conducted with 178 patients presenting at St. Michael's Hospital with primary retinal detachment (RD). Inclusion criteria include: a single or multiple retinal tears in detached retina between 7 and 5 o'clock being of any size and any distance apart from each other, including giant retinal tears with inferior aspect above 5 and 7 o'clock, RD with no identifiable tear but where suspected tear is between 7 and 5 o'clock, retinoschisis with RD if tears are located between 7 and 5 o'clock, mild proliferative vitreoretinopathy, none or mild vitreous hemorrhage. Patients will be excluded if there is a small retinal tear or multiple tears less than 30o apart between 8 and 4 o'clock in detached retina, retinal tear in detached retina between 5 and 7 o'clock, <18 years old, inability to read English, mental incapacity, previous history of RD, scleral buckle or vitrectomy in index eye, inability to maintain appropriate head posture at post-operative period and inability to visualize peripheral retinal due to media opacity. Patients will be randomly allocated into two groups: PnR + cryotherapy/laser or vitrectomy + cryotherapy/laser and the intervention will take place within 24 hours and 72 hours for attached and detached macula status, respectively. Patients will undergo a complete ophthalmological examination, including visual acuity and fundus assessment at baseline and at 3, 6 and 12 months after surgery. Visual acuity will also be measured at 1, 7 and 30 days after surgery. Global health related quality of life will be evaluated with the SF-36v2 questionnaire at baseline, 1 month, 1 and 2 years after intervention, while the VFG25 questionnaire will be applied at 3, 6, 12 and 24 months after surgery to measure vision related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumatic retinopexy | Experimental | Procedure: Pneumatic retinopexyPatients with retinal detachment allocated to pneumatic retinopexy |
| Vitrectomy | Experimental | Procedure: VitrectomyPatients with retinal detachment allocated to vitrectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Single retinal tear or group of tears (any distance apart) in detached retina located between 7 and 5 o'clock.
- Retinal detachment with no identifiable tear but where suspected tear is located between 7-5 o'clock based on Lincoff rules
- Any size of retinal tear, including giant retinal tears, if the inferior aspect of it is above 5 and 7 o'clock
- Retinoschisis with retinal detachment if tears are located between 7 and 5 o'clock
- There may be mild proliferative vitreoretinopathy (unless there is a visible traction on the break)
Key exclusion criteria (10 listed)
- Group of tears <30o apart in detached retina if all located within 8-4 o'clock
- Single retinal tear smaller than 1 o'clock in detached retina between 8-4 o'clock
- Retinal tears below the 5 and 7 o'clock meridian in detached retina (note that additional tears in attached retina are acceptable)
- Inability to read English language
- Age <18 years
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 |
|---|---|---|
| Pneumatic retinopexyAlso: Pneumatic retinopexy plus laser/cryotherapy | Procedure or surgery | Pneumatic retinopexy |
| VitrectomyAlso: Pars plana vitrectomy plus laser/cryotherapy | Procedure or surgery | Vitrectomy |
Primary outcome
Visual acuity (ETDRS)
Time frame: 12 months post intervention
8 secondary outcomes
Visual acuity (ETDRS)
Time frame: 3, 6 and 24 months post intervention
Visual acuity (Snellen)
Time frame: 1 week, 1, 3, 6, 12 and 24 months post intervention
Subjective visual function (VFQ25)
Time frame: 3, 6, 12 and 24 months post intervention
Anatomical success (complete retinal re-attachment with no adjuvant surgical procedure)
Time frame: 3, 6, 12 and 24 months post intervention
Subjective health related quality of life (SF-36v2)
Time frame: baseline, 1 month, 12 and 24 months post intervention
Aniseikonia rates
Time frame: 12 and 24 months
Metamorphopsia rates
Time frame: 3, 12 and 24 months
Retinal displacement rate measured with fundus autofluorescence
Time frame: 3 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
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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 Muni, FRSCS principal investigator
staff
Verena Juncal, MD principal investigator
research fellow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pneumatic retinopexy and Vitrectomy in people with Rhegmatogenous Retinal Detachment, run by Unity Health Toronto at 2 sites 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 7 inclusion and 10 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rajeev Muni, MD (416-867-7411, rajeev.muni@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (ETDRS) (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?
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 26 Aug 2019.