Effect of Type of Head Positioning on Retinal Displacement in Vitrectomy for Retinal Detachment

NCT04035343 | Unknown

• 1 other identifier: 18-374
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Detachment; Metamorphopsia

Outcome Measures

Primary Outcomes (1)

• Retinal displacement

  The presence of retinal vessels printing on fundus autofluorescence imaging.

  3 months

Secondary Outcomes (6)

• Visual Distortion

  3 months

• Aniseikonia

  3 months

• Optical coherence tomography (OCT) changes

  3 months

• Optical coherence tomography angiography (OCTA) changes

  3 months

• Metamorphopsia

  3 months

Study Arms (2)

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.

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.

Behavioral: Supine positioning

Interventions

Face down positioning BEHAVIORAL

See description of the face down positioning group

Conventional face down positioning

Supine positioning BEHAVIORAL

See description of the supine positioning group

Supine positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Department of Ophthalmology, St. Michael's Hospital

Toronto, Ontario, M5C 2T2, Canada

RECRUITING

MeSH Terms

Conditions

Retinal Detachment; Vision Disorders

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: July 29, 2019
• Study Start: August 26, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CA (1)