Study Stopped
Study terminated due to insufficient subject participation
Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2010
CompletedNovember 24, 2017
November 1, 2017
2.8 years
February 25, 2008
November 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pupil diameter after hydrodissection
2 years
Secondary Outcomes (3)
Pupil diameter after nuclear removal
2 years
Pupil diameter after cortex removal
2 years
Pupil diameter at conclusion of surgery
2 years
Study Arms (2)
1
ACTIVE COMPARATORHealon 5
2
EXPERIMENTALRetrobulbar Anesthetic Injection
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- All cataract patients taking tamsulosin
You may not qualify if:
- Patients with any history of iridocyclitis
- Presence of iris neovascularization
- History of prior iris surgery
- Presence of traumatic cataracts
- Presence of zonular dialysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State Hershey Eye Center
Hershey, Pennsylvania, 17036, United States
Related Publications (1)
Chang DF, Osher RH, Wang L, Koch DD. Prospective multicenter evaluation of cataract surgery in patients taking tamsulosin (Flomax). Ophthalmology. 2007 May;114(5):957-64. doi: 10.1016/j.ophtha.2007.01.011.
PMID: 17467530BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmad A Aref, M.D.
The Penn State Hershey Eye Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2008
First Posted
March 4, 2008
Study Start
February 1, 2008
Primary Completion
November 11, 2010
Study Completion
November 11, 2010
Last Updated
November 24, 2017
Record last verified: 2017-11