Vitreous Surgery With Intraocular Assistance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitreous Surgery With Intraocular Assistance (VISIA)

Conditions
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Traction Retinal Detachments, Rhegmatogenous Retinal Detachments, Dislocated Intraocular Lens

Intervention / Treatment
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* Procedure: Intraocular assistance


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraocular Assistance<br>Intraocular assistance in patients undergoing standard of care vitreous surgeries | Procedure: Intraocular assistance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is recording of adverse events directly related to VISIA and adverse events unrelated to VISIA. |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |