Vitreous Surgery With Intraocular Assistance (VISIA)

Johns Hopkins University

Status: Terminated

Conditions: Rhegmatogenous Retinal Detachments; Traction Retinal Detachments; Dislocated Intraocular Lens

Treatments: Procedure: Intraocular assistance

Study type: Interventional

Funder types: Other

Identifiers

NCT02574624

VISIA

Details and patient eligibility

About

To Assess the Safety of Vitreous surgery with intraocular assistance (VISIA) & to identify and document with video evidence and surgeon's case report forms intraocular maneuvers that are facilitated by VISIA.

Full description

Standard care surgery will be done with a few novel additions to facilitate the surgical procedure. Currently 3 ports are inserted by creating holes in the sclera (white part of the eye) to enter into the posterior part of the eye. When complex dissection is needed, a fourth port will be inserted. The assistant will insert light source through the 4th port. This eliminates the need for the surgeon to hold the light in one hand. Hence allows freeing of both hands for the surgeon to use a forceps in one hand to grasp and elevate membranes and a scissors in the other to cut connections between the retina and the membranes. When membranes are particularly thick, it can be difficult to dissect with a single forceps holding up the membrane. In this situation, a 5th port will be inserted allowing the assistant to insert a light source through one and a forceps though another. The surgeon will have a forceps in one hand and a scissors in another making dissection process more efficient.

Enrollment: 5 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All subjects must meet the following criteria to be eligible for study entry:

• Signed informed consent and authorization of use and disclosure of protected health information
• Age ≥18 years
• Subject will have complex retinal pathology for which it is judged that surgical objectives could be facilitated by VISIA

Exclusion criteria

Subjects who meet any of the following criteria will be ineligible for study entry:

• Patients with disease processes such as macular pucker and macular hole that are generally well-managed by standard two-handed vitrectomy.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Intraocular Assistance

Experimental group

Description:

Intraocular assistance in patients undergoing standard of care vitreous surgeries

Treatment:

Procedure: Intraocular assistance