Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pneumatic Retinopexy for Primary Rhegmatogenous Retinal Detachment: To Steamroll or Not

Conditions
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Rhegmatogenous Retinal Detachment

Intervention / Treatment
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* Other: Steamroller technique
* Other: Direct technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steamroller Technique<br>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. | Other: Steamroller technique<br>* 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.<br>|
| Active Comparator: Direct Technique<br>Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break. | Other: Direct technique<br>* Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24hours post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical displacement of macula and its changes with time. | Measurement of retinal vessel imprinting on fundus autofluorescence | 1,2, 3 and 6 months post intervention | 
| Functional displacement of macula and its changes with time. | Measurement of metamorphopsia with M-charts | 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 | 1hour, 2hours, Day 2, Week 1, Week 2 | 
| Visual acuity | ETDRS | 1, 3 and 6 months post intervention | 
| Primary anatomical success | Complete reattachment of retina via clinical fundus examination and optos fundus photography | 1, 3 and 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumatic Retinopexy, Steamroll, Direct to break