Vitreous Surgery With Intraocular Assistance

NCT ID: NCT02574624

Last Updated: 2017-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-09-30

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.

Conditions

Traction Retinal Detachments; Rhegmatogenous Retinal Detachments; Dislocated Intraocular Lens

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intraocular Assistance

Intraocular assistance in patients undergoing standard of care vitreous surgeries

Group Type: EXPERIMENTAL

Intraocular assistance

Intervention Type: PROCEDURE

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.

Interventions

Intraocular 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Peter A Campochiaro, MD

Professor of Ophthalmology and Neuroscience

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter A. Campochiaro, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Wilmer Eye Institute, Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

VISIA

Identifier Type: -

Identifier Source: org_study_id