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Clinical Trials/NCT00627913
NCT00627913TerminatedNot Applicable

Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome

Penn State University2 sites in 1 country6 target enrollmentStarted: February 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
6
Locations
2
Primary Endpoint
Pupil diameter after hydrodissection
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

In this study, the investigators plan to compare the incidence and complications of intraoperative floppy iris syndrome (IFIS) during cataract surgery in patients taking tamsulosin (Flomax) and treated with retrobulbar injection of anesthesia, versus injection of Healon 5 viscoelastic into the anterior chamber.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All cataract patients taking tamsulosin

Exclusion Criteria

  • •Patients with any history of iridocyclitis
  • •Presence of iris neovascularization
  • •History of prior iris surgery
  • •Presence of traumatic cataracts
  • •Presence of zonular dialysis

Arms & Interventions

1

Active Comparator

Healon 5

Intervention: Healon 5 injection (Procedure)

2

Experimental

Retrobulbar Anesthetic Injection

Intervention: Retrobulbar anesthetic injection (Procedure)

Outcomes

Primary Outcomes

Pupil diameter after hydrodissection

Time Frame: 2 years

Secondary Outcomes

  • Pupil diameter at conclusion of surgery(2 years)
  • Pupil diameter after nuclear removal(2 years)
  • Pupil diameter after cortex removal(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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