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Vitreous Surgery With Intraocular Assistance (VISIA)

Primary Purpose

Traction Retinal Detachments, Rhegmatogenous Retinal Detachments, Dislocated Intraocular Lens

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraocular assistance
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Traction Retinal Detachments

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wilmer Eye Institute, Johns Hopkins University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraocular Assistance

Arm Description

Intraocular assistance in patients undergoing standard of care vitreous surgeries

Outcomes

Primary Outcome Measures

The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.

Secondary Outcome Measures

Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.

Full Information

First Posted
September 24, 2015
Last Updated
September 25, 2017
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02574624
Brief Title
Vitreous Surgery With Intraocular Assistance
Acronym
VISIA
Official Title
Vitreous Surgery With Intraocular Assistance (VISIA)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in finding patients with complex retinal pathology to enroll in this study.
Study Start Date
November 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traction Retinal Detachments, Rhegmatogenous Retinal Detachments, Dislocated Intraocular Lens

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraocular Assistance
Arm Type
Experimental
Arm Description
Intraocular assistance in patients undergoing standard of care vitreous surgeries
Intervention Type
Procedure
Intervention Name(s)
Intraocular assistance
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Time Frame
4 months
Title
Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. Campochiaro, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmer Eye Institute, Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vitreous Surgery With Intraocular Assistance

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