Clinical trial NCT02574624: Vitreous Surgery With Intraocular Assistance
Official title: Vitreous Surgery With Intraocular Assistance (VISIA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traction Retinal Detachments
Rhegmatogenous Retinal Detachments
Dislocated Intraocular Lens
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
timeFrame: 4 months
Secondary outcomes:
measure: Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
timeFrame: 4 months
measure: Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
timeFrame: 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Wilmer Eye Institute, Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter A. Campochiaro, MD
role: PRINCIPAL_INVESTIGATOR
References: