Epiretinal Membrane, Macular Hole, Proliferative Diabetic Retinopathy, Retained Lens Material in the Posterior Segment, Rhegmatogenous Retinal Detachment, Visually Significant Vitreous Floater, Vitreomacular Traction, Vitreous Hemorrhage
Conditions
Keywords
Vitreoretinal Disease
Brief summary
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
Detailed description
Subjects will attend a total of 6 scheduled visits for an individual of participation of approximately 3 months. One eye (study eye) will be treated with either UNITY VCS or CONSTELLATION, as randomized.
Interventions
PROCEDUREVitreoretinal ophthalmic surgery
Ophthalmic surgery performed in the posterior segment of the eye
DEVICEUNITY Vitreoretinal Cataract System (VCS)
UNITY VCS is a commercially approved surgical system that facilitates the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during eye surgery. In this study, the UNITY VCS posterior segment functionalities will be used to perform posterior segment (i.e., vitreoretinal) ophthalmic surgery.
DEVICECONSTELLATION Vision System
CONSTELLATION is a commercially approved, multifunctional surgical instrument used during ophthalmic surgery to cut vitreous and tissues, emulsify the lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding.
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Requires surgery for a clinically documented posterior vitreoretinal medical condition. * Clear ocular media except for vitreous hemorrhage and floaters undergoing surgery. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Presence of clinically significant ocular or systemic diseases that may interfere with study outcomes or safety. * Diagnosis of glaucoma or suspected ocular hypertension. * Recent intraocular eye surgery, other than cataract surgery, resulting in retained lens materials in the posterior segment (within the past 3-months). * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of vitreoretinal surgeries performed using 27-gauge consumables | Day 0 operative | The surgeon will select the gauge size of the surgical consumables used for vitreoretinal surgery |
Countries
United States
Outcome results
None listed