Intraoperative Floppy Iris SyndromeNCT00627913
Retrobulbar Injection of Anesthesia Versus Healon 5 in the Management of Intraoperative Floppy Iris Syndrome
A study testing Healon 5 injection and Retrobulbar anesthetic injection in people with Intraoperative Floppy Iris Syndrome, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intraoperative Floppy Iris Syndrome
- What is being tested?
- Healon 5 injection and Retrobulbar anesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to 11 Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cataract patients taking tamsulosin
Who cannot join
- Patients with any history of iridocyclitis
- Presence of iris neovascularization
- History of prior iris surgery
- Presence of traumatic cataracts
- Presence of zonular dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Eye Center
Hershey, Pennsylvania, 17036
About this study
Official title: Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome
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.
- Conditions
- Intraoperative Floppy Iris Syndrome
- Being tested
- Healon 5 injection, Retrobulbar anesthetic injection
- Keywords
- Floppy Iris Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healon 5 injectionProcedure or surgery
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.
Retrobulbar anesthetic injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Healon 5 Receives: Procedure: Healon 5 injection |
| 2 | Experimental | Retrobulbar Anesthetic Injection Receives: Procedure: Retrobulbar anesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil diameter after hydrodissection
Measured: 2 years
Secondary outcomes (3)
Pupil diameter after nuclear removal
Measured: 2 years
Pupil diameter after cortex removal
Measured: 2 years
Pupil diameter at conclusion of surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completion11 Nov 2010
- Study completion11 Nov 2010
Why it stopped: Study terminated due to insufficient subject participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative Floppy Iris SyndromeStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmad A Aref, M.D., Principal investigator, The Penn State Hershey Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627913
- Sponsor's protocol ID
- 27170
- Status last verified
- Nov 2017
- First submitted
- 25 Feb 2008
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17467530
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrobulbar Injection of Anesthesia Versus Injection of Healon 5 Viscoelastic Into the Anterior Chamber in the Management of Intraoperative Floppy Iris Syndrome
- ClinicalTrials.gov ID
- NCT00627913
- Acronym / sponsor ID
- 27170
- Conditions
- Intraoperative Floppy Iris Syndrome
- Keywords
- Floppy Iris Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to insufficient subject participation
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- 11 Nov 2010 (actual)
- Study completion
- 11 Nov 2010 (actual)
- First posted
- 4 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Healon 5 injectionHealon 5 |
| 2 | Experimental | Procedure: Retrobulbar anesthetic injectionRetrobulbar Anesthetic Injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cataract patients taking tamsulosin
Key exclusion criteria (5 listed)
- Patients with any history of iridocyclitis
- Presence of iris neovascularization
- History of prior iris surgery
- Presence of traumatic cataracts
- Presence of zonular dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healon 5 injectionHealon 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. | Procedure or surgery | 1 |
| Retrobulbar anesthetic injection3-4cc 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. | Procedure or surgery | 2 |
Primary outcome
Pupil diameter after hydrodissection
Time frame: 2 years
3 secondary outcomes
Pupil diameter after nuclear removal
Time frame: 2 years
Pupil diameter after cortex removal
Time frame: 2 years
Pupil diameter at conclusion of surgery
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Study terminated due to insufficient subject participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Background: PubMed 17467530Chang 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.
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Benign Prostatic Hyperplasia, Tamsulosin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmad A Aref, M.D. principal investigator
The Penn State Hershey Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healon 5 injection and Retrobulbar anesthetic injection in people with Intraoperative Floppy Iris Syndrome, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to insufficient subject participation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil diameter after hydrodissection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627913, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.