Vitreous Surgery With Intraocular Assistance

Not Applicable

Terminated

• Conditions: Traction Retinal Detachments; Rhegmatogenous Retinal Detachments; Dislocated Intraocular Lens
• Interventions: Procedure: Intraocular assistance

• Registration Number: NCT02574624
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-14
• Study Start: 2015-11
• Status Verified: 2017-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Last Update Submitted: 2017-09-25
• Last Update Posted: 2017-09-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraocular Assistance	Intraocular assistance	Intraocular assistance in patients undergoing standard of care vitreous surgeries

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.	4 months

Secondary Outcome Measures

Name	Time	Method
Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.	4 months
Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.	4 months

Trial Locations

Locations (1)

Wilmer Eye Institute, Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States