Vitreous Surgery With Intraocular Assistance

Dislocated Intraocular Lens Clinical Trial

— VISIA  

Official title:

Vitreous Surgery With Intraocular Assistance (VISIA)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02574624
• Other study ID #: VISIA
• Status: Terminated
• Phase: N/A
• First received: September 24, 2015
• Last updated: September 25, 2017
• Start date: November 2015
• Est. completion date: September 2017

Study information

• Verified date: September 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dislocated Intraocular Lens
• Dissociative Disorders
• Retinal Detachment
• Rhegmatogenous Retinal Detachments
• Traction Retinal Detachments

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Wilmer Eye Institute, Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.		4 months
Secondary	Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.		4 months
Secondary	Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.		4 months