Retinal DetachmentDIAMONDNCT04035343
Effect of Type of Head Positioning on Retinal Displacement in Vitrectomy for Retinal Detachment
A study testing Face down positioning and Supine positioning in people with Retinal Detachment and Metamorphopsia, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Patients may experience metamorphopsia, or image distortion, after having vitrectomy to repair their rhegmatogenous retinal detachments especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment, Metamorphopsia
- What is being tested?
- Face down positioning and Supine positioning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2019to Oct 2024
- 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
- Age ≥ 18
- Diagnosis of primary rhegmatogenous retinal detachment needing pars plana vitrectomy with the detachment involving at least one of the temporal vascular arcades, which would allow retinal displacement to be detected on fundus autofluorescence photography
Who cannot join
- Rhegmatogenous retinal detachment with an attached macula
- Proliferative retinopathy grade C or worst
- Prior vitrectomy for retinal detachment. Patients having had pneumatic retinopexy that failed to completely reattach the retina and therefore now needing vitrectomy are allowed into the study
- History of preoperative binocular diplopia
- Tamponade with silicone oil instead of gas
- Inability to maintain post operation head positioning
- Mental incapacity
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, St. Michael's Hospital
Toronto, Ontario, M5C 2T2
Rajeev Muni, MD Msc FRCSC, 4168677411, Rajeev.Muni@unityhealth.to
Phillip To, 4168677411, Philip.To@unityhealth.to
About this study
Official title: Difference In Anatomic Integrity in Vitrectomy for Macula Off Rhegmatogenous RetiNal Detachments With Face Down Compared to Supine Positioning (the DIAMOND Study)
Patients may experience metamorphopsia, or image distortion, after having vitrectomy to repair their rhegmatogenous retinal detachments especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. It is thought that the retina slips inferiorly due to the residual subretinal fluid shifting as the patient transitions from the supine position intraoperatively to the sitting up position in the immediate postoperative period. By having the patient immediate position facedown or according to the retinal break, the risk of slippage is theoretically decreased.
Read the detailed description
Rhegmatogenous retinal detachments (RRD) are a sight-threatening condition with an incidence of approximately 10 per 100 000 people. RRDs can be broadly classified into those with the macula still attached, and those with the macula detached. Visual prognosis for RRDs with attached macula tend to be much better than those with detached macula. Pars plana vitrectomy (PPV) is one of the procedures used to treat RRD. PPV is carried out in the operating room under regional anesthestic, and often times sedation. The retina is reattached by either draining the subretinal fluid through a peripheral retinal break, by draining the subretinal fluid through a posterior retinotomy, or by using a heavier-than-water liquid such as perfluorocarbon to push out the subretinal fluid. At the end of the surgery, the vitreous cavity is filled with a substance that will tamponade the retina to the wall of the eye. Tamponade agents can be temporary, such as sulfur hexafluoride (SF6) and octafluoropropane (C3F8), or long term, such as silicone oil. After the surgery, patients are usually told to put their facedown allowing the tamponade agent to keep the macula attached while the remaining subretinal fluid is reabsorbed by the retinal pigment epithelium. Alternatively, some surgeons ask that their patients position according to the location of their retinal breaks with the aim for the buoyant gas bubble to cover the break or breaks. Patients may experience metamorphopsia, or image distortion, after having their RRD repaired especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. Supine positioning in theory covers all break locations as usually breaks occur in the anterior part of the retina near the vitreous base. This position has the advantage of being more ergonomic than face down. Depending on the results, this study might provide evidence for the current standard of care, which is face down positioning for the first day after vitrectomy for retinal detachment. Or, if supine positioning demonstrates superiority in reducing the risk of retinal displacement, patients would be able to maintain a more comfortable position after surgery.
- Conditions
- Retinal Detachment, Metamorphopsia
- Being tested
- Face down positioning, Supine positioning
- Medical subject headings
- Retinal Detachment, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face down positioningBehavioural
See description of the face down positioning group
Supine positioningBehavioural
See description of the supine positioning group
| Study group | Role | What they receive |
|---|---|---|
| Conventional face down positioning | Active comparator | Patients in third arm will be treated with the current standard of care, that is, they will be kept supine in the ophthalmic surgery chair after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will transition to face down positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery. Receives: Behavioral: Face down positioning |
| Supine positioning | Experimental | Patients in the second arm will be kept supine after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will maintain supine positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery. Receives: Behavioral: Supine positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal displacement
The presence of retinal vessels printing on fundus autofluorescence imaging.
Measured: 3 months
Secondary outcomes (6)
Visual Distortion
measured with M chart.
Measured: 3 months
Aniseikonia
Measured with aniseikonia testing. The aniseikonia test measures the ratio of image size difference between the 2 eyes
Measured: 3 months
Optical coherence tomography (OCT) changes
Changes seen on OCT
Measured: 3 months
Optical coherence tomography angiography (OCTA) changes
Changes seen on OCTA
Measured: 3 months
Metamorphopsia
Metamorphopsia is the image distortion experienced by the patient. It will be recorded in a data collection sheet as "yes" or "no" according to the patient subjective complain on metamorphopsia.
Measured: 3 months
Best corrected Visual Acuity measured in "Early Treatment of Diabetic Retinopathy Study" letters
Best corrected Visual Acuity measured in "Early Treatment of Diabetic Retinopathy Study" letters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start26 Aug 2019
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035343
- Sponsor's protocol ID
- 18-374
- Acronym
- DIAMOND
- Status last verified
- Apr 2021
- First submitted
- 11 Feb 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference In Anatomic Integrity in Vitrectomy for Macula Off Rhegmatogenous RetiNal Detachments With Face Down Compared to Supine Positioning (the DIAMOND Study)
- ClinicalTrials.gov ID
- NCT04035343
- Acronym / sponsor ID
- DIAMOND / 18-374
- Conditions
- Retinal Detachment, Metamorphopsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 29 Jul 2019 (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.
Patients may experience metamorphopsia, or image distortion, after having vitrectomy to repair their rhegmatogenous retinal detachments especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. It is thought that the retina slips inferiorly due to the residual subretinal fluid shifting as the patient transitions from the supine position intraoperatively to the sitting up position in the immediate postoperative period. By having the patient immediate position facedown or according to the retinal break, the risk of slippage is theoretically decreased.
Detailed description
Rhegmatogenous retinal detachments (RRD) are a sight-threatening condition with an incidence of approximately 10 per 100 000 people. RRDs can be broadly classified into those with the macula still attached, and those with the macula detached. Visual prognosis for RRDs with attached macula tend to be much better than those with detached macula. Pars plana vitrectomy (PPV) is one of the procedures used to treat RRD. PPV is carried out in the operating room under regional anesthestic, and often times sedation. The retina is reattached by either draining the subretinal fluid through a peripheral retinal break, by draining the subretinal fluid through a posterior retinotomy, or by using a heavier-than-water liquid such as perfluorocarbon to push out the subretinal fluid. At the end of the surgery, the vitreous cavity is filled with a substance that will tamponade the retina to the wall of the eye. Tamponade agents can be temporary, such as sulfur hexafluoride (SF6) and octafluoropropane (C3F8), or long term, such as silicone oil. After the surgery, patients are usually told to put their facedown allowing the tamponade agent to keep the macula attached while the remaining subretinal fluid is reabsorbed by the retinal pigment epithelium. Alternatively, some surgeons ask that their patients position according to the location of their retinal breaks with the aim for the buoyant gas bubble to cover the break or breaks. Patients may experience metamorphopsia, or image distortion, after having their RRD repaired especially those with a detached macula. Retinal displacement, as measured on autofluorescence photography, likely contributes to this distortion. Supine positioning in theory covers all break locations as usually breaks occur in the anterior part of the retina near the vitreous base. This position has the advantage of being more ergonomic than face down. Depending on the results, this study might provide evidence for the current standard of care, which is face down positioning for the first day after vitrectomy for retinal detachment. Or, if supine positioning demonstrates superiority in reducing the risk of retinal displacement, patients would be able to maintain a more comfortable position after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional face down positioning | Active comparator | Behavioral: Face down positioningPatients in third arm will be treated with the current standard of care, that is, they will be kept supine in the ophthalmic surgery chair after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will transition to face down positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery. |
| Supine positioning | Experimental | Behavioral: Supine positioningPatients in the second arm will be kept supine after the completion of their surgery. They will then be taken to the recovery area where, once transferred to the care of the postoperative care unit staff, they will maintain supine positioning. They will maintain this positioning until their first day postoperative visit after which they will position according to the retinal breaks found during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- Diagnosis of primary rhegmatogenous retinal detachment needing pars plana vitrectomy with the detachment involving at least one of the temporal vascular arcades, which would allow retinal displacement to be detected on fundus autofluorescence photography
Key exclusion criteria (7 listed)
- Rhegmatogenous retinal detachment with an attached macula
- Proliferative retinopathy grade C or worst
- Prior vitrectomy for retinal detachment. Patients having had pneumatic retinopexy that failed to completely reattach the retina and therefore now needing vitrectomy are allowed into the study
- History of preoperative binocular diplopia
- Tamponade with silicone oil instead of gas
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 |
|---|---|---|
| Face down positioningSee description of the face down positioning group | Behavioural | Conventional face down positioning |
| Supine positioningSee description of the supine positioning group | Behavioural | Supine positioning |
Primary outcome
Retinal displacement
Time frame: 3 months
The presence of retinal vessels printing on fundus autofluorescence imaging.
6 secondary outcomes
Visual Distortion
Time frame: 3 months
Aniseikonia
Time frame: 3 months
Optical coherence tomography (OCT) changes
Time frame: 3 months
Optical coherence tomography angiography (OCTA) changes
Time frame: 3 months
Metamorphopsia
Time frame: 3 months
Best corrected Visual Acuity measured in "Early Treatment of Diabetic Retinopathy Study" letters
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Related trials for Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Department of Ophthalmology, 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 Face down positioning and Supine positioning in people with Retinal Detachment and Metamorphopsia, 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 2 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 28 Apr 2021. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal displacement (time frame: 3 months). 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 28 Apr 2021.