Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitrectomy
Intervention: Vitrectomy using triamcinolone acetonide (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Dana Sager, M.S., Study Director, Affiliation: Alcon Research
Summary
Vitreous delineating agents are used in ophthalmic surgery to permit visualization of
structures in the back of the eye to aid in their removal and improve safety of the surgery.
If you agree to participate in the study, your surgeon will inject the vitreous delineating
agent inside your eye at some point during your surgery. When your surgeon no longer needs a
visualization aid, the vitreous delineating agent will be removed from the inside of your eye
as much as possible. If you decide to participate, this clinical study will last
approximately one week.
Clinical Details
Official title: Clinical Evaluation of the Safety and Efficacy of Vitreous Delineating Agent for Visualization During Vitrectomy Surgery
Study design: Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Masked reader evaluations of the visualization or posterior segment structures in pars plana vitrectomy before andn after instillation of the vitreous delineating agent.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients planning to undergo pars plana vitrectomy with good vision in the non-surgery
eye. The study excludes patients with previous vitrectomy, elevated IOP and/or
history of ocular inflammatory disease.
Exclusion Criteria:
- Patients under 18
Locations and Contacts
Houston, Houston, Texas 77025, United States
Additional Information
Starting date: September 2007
Last updated: March 26, 2008
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