An interventional study of Intraocular assistance in Traction Retinal Detachments, Rhegmatogenous Retinal Detachments and Dislocated Intraocular Lens, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-09-26.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Health services research
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.
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.
207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 136 interventional studies indexed under Retinal Detachment.
Browse Retinal Detachment studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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All subjects must meet the following criteria to be eligible for study entry:
Exclusion Criteria:
Subjects who meet any of the following criteria will be ineligible for study entry:
Intraocular assistance in patients undergoing standard of care vitreous surgeries
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.
The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA.
Time frame: 4 months
Surgeon's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Time frame: 4 months
Assistant's assessment of the benefits and risks of VISIA recorded on the surgical case report form.
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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