Dislocated Intraocular Lens, Rhegmatogenous Retinal Detachments, Traction Retinal Detachments
Conditions
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.
Interventions
PROCEDUREIntraocular assistance
Intraocular assistance with help of surgical assistants during vitreous surgery (VISIA) in patients who require vitreous surgeries as part of standard of care procedure for conditions like retinal detachments, dislocated intraocular lens and glaucoma patients requiring endophotocoagulation.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form. | 4 months |
| Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form. | 4 months |
Countries
United States
Outcome results
None listed