Intraoperative Floppy Iris Syndrome
Conditions
Keywords
Floppy Iris Syndrome
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.
Interventions
PROCEDUREHealon 5 injection
Healon 5 (2.3% Sodium hyaluronate) ophthalmic viscoelastic device will be injected into the anterior chamber as needed for pupillary dilation and adequate cataract extraction with intraocular lens placement.
PROCEDURERetrobulbar anesthetic injection
3-4cc of anesthetic (1% lidocaine/0.75% bupivicaine) will be injected with a 25 gauge needle into the extraocular muscle cone prior to patient and microscope positioning. Cataract extraction with intraocular lens placement will then proceed in standard fashion.
Sponsors
Penn State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pupil diameter after hydrodissection | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Pupil diameter after nuclear removal | 2 years |
| Pupil diameter after cortex removal | 2 years |
| Pupil diameter at conclusion of surgery | 2 years |
Countries
United States
Outcome results
None listed