Clinical trial NCT04035343: Effect of Type of Head Positioning on Retinal Displacement in Vitrectomy for Retinal Detachment
Official title: Difference In Anatomic Integrity in Vitrectomy for Macula Off Rhegmatogenous RetiNal Detachments With Face Down Compared to Supine Positioning (the DIAMOND Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Detachment
Metamorphopsia
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Retinal displacement
timeFrame: 3 months
Secondary outcomes:
measure: Visual Distortion
timeFrame: 3 months
measure: Aniseikonia
timeFrame: 3 months
measure: Optical coherence tomography (OCT) changes
timeFrame: 3 months
measure: Optical coherence tomography angiography (OCTA) changes
timeFrame: 3 months
measure: Metamorphopsia
timeFrame: 3 months
measure: Best corrected Visual Acuity measured in "Early Treatment of Diabetic Retinopathy Study" letters
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Ophthalmology, St. Michael's Hospital
state: Ontario
Study officials:
References: