Study Stopped
Difficulty in finding patients with complex retinal pathology to enroll in this study.
Vitreous Surgery With Intraocular Assistance
VISIA
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 26, 2017
September 1, 2017
1.8 years
September 24, 2015
September 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
4 months
Secondary Outcomes (2)
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
Study Arms (1)
Intraocular Assistance
EXPERIMENTALIntraocular assistance in patients undergoing standard of care vitreous surgeries
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wilmer Eye Institute, Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Peter A. Campochiaro, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology and Neuroscience
Study Record Dates
First Submitted
September 24, 2015
First Posted
October 14, 2015
Study Start
November 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
September 26, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share