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

Rhegmatogenous Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04723420
• Other study ID #: 270-2019
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: December 7, 2023

Study information

• Verified date: April 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Study Coordinator
• Phone: 416-480-5091
• Email: Cindy.Rutz[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

Other:
• Steamroller technique
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 technique
Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Functional displacement of macula and its changes with time.	Measurement of metamorphopsia with M-charts	1,2, 3 and 6 months post intervention
Secondary	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
Secondary	Visual acuity	ETDRS	1, 3 and 6 months post intervention
Secondary	Primary anatomical success	Complete reattachment of retina via clinical fundus examination and optos fundus photography	1, 3 and 6 months post intervention