Pupil ConstrictionNCT00472888
Clinical Factors Associated Floppy Iris
An observational study of Pupil Constriction and Iris Floppiness, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study is planned to investigate the incidence of intraoperative floppy iris and its relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1 adrenergic blocker use. Read more about this study
- Who is it for?
- Ages 28 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pupil Constriction, Iris Floppiness, Iris Prolapsus From the Wound
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2005to Nov 2006
- Phase
- Observational
- 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 28 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with the diagnosis of cataract who were decided to have phacoemulsification
Who cannot join
- Previous history of trauma or surgery of the eye, congenital ocular disease including cataract, infection, inflammation, angle closure glaucoma, or medication (topical) that might affect the size and shape of the pupil
- Only the first operated eye of each patient was included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University, Faculty of Medicine, Department of Ophthalmology
Ankara, 06490
About this study
Official title: Clinical Factors Associated With Floppy Iris Signs: a Prospective Study From Two Centers
This study is planned to investigate the incidence of intraoperative floppy iris and its relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1 adrenergic blocker use.
Read the detailed description
Our aim is to investigate the incidence of intraoperative floppy iris syndrome (IFIS) signs and evaluate the relationship of IFIS signs as well as complete IFIS with pseudoexfoliation, diabetes, hypertension, and alpha-1 adrenergic blocker (A1AB) use. Five-hundred patients will be included in this prospective study. Preoperatively, pupil diameter before and after dilation, presence of pseudoexfoliation, history of diabetes, hypertension, and use of any A1AB will be recorded. Intraoperative adverse events such as pupillary constriction, iris billowing, and iris prolapse from the wound will be noted. Multinomial regression analysis will be used to evaluate the relationship of IFIS signs with pseudoexfoliation, diabetes, hypertension, and A1AB usage. According to the results we will determine the incidence of IFIS in our patient population and evaluate its relationship with alpha-1 adrenergic blocker use. We will also investigate the relationship of floppy iris problems with pseudoexfoliation, diabetes, high blood pressure.
- Keywords
- Alpha-adrenergic blockers, cataract surgery, pseudoexfoliation syndrome, diabetes mellitus, hypertension, pupil
- Medical subject headings
- Miosis, Exfoliation Syndrome, Diabetes Mellitus, Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startNov 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pupil ConstrictionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Investigators
- Rana Altan-Yaycioglu, MD, Study chair, Baskent University, Faculty of Medicine, Department of OphthalmologyYonca A Akova, MD, Study director, Baskent University, Faculty of Medicine, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472888
- Sponsor's protocol ID
- KA 05/244
- Status last verified
- May 2007
- First submitted
- 10 May 2007
- Last updated
- 14 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005 Apr;31(4):664-73. doi: 10.1016/j.jcrs.2005.02.027.
PubMed 15899440Schwinn DA, Afshari NA. alpha(1)-Adrenergic receptor antagonists and the iris: new mechanistic insights into floppy iris syndrome. Surv Ophthalmol. 2006 Sep-Oct;51(5):501-12. doi: 10.1016/j.survophthal.2006.06.011.
PubMed 16950249Altan-Yaycioglu R, Gedik S, Pelit A, Akova YA, Akman A. Clinical factors associated with floppy iris signs: a prospective study from two centers. Ophthalmic Surg Lasers Imaging. 2009 May-Jun;40(3):232-8. doi: 10.3928/15428877-20090430-02.
PubMed 19485285
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Factors Associated With Floppy Iris Signs: a Prospective Study From Two Centers
- ClinicalTrials.gov ID
- NCT00472888
- Acronym / sponsor ID
- KA 05/244
- Keywords
- Alpha-adrenergic blockers, cataract surgery, pseudoexfoliation syndrome, diabetes mellitus, hypertension, pupil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Nov 2006 (actual)
- First posted
- 14 May 2007 (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.
This study is planned to investigate the incidence of intraoperative floppy iris and its relationship with pseudoexfoliation, diabetes, hypertension as well as systemic alpha-1 adrenergic blocker use.
Detailed description
Our aim is to investigate the incidence of intraoperative floppy iris syndrome (IFIS) signs and evaluate the relationship of IFIS signs as well as complete IFIS with pseudoexfoliation, diabetes, hypertension, and alpha-1 adrenergic blocker (A1AB) use. Five-hundred patients will be included in this prospective study. Preoperatively, pupil diameter before and after dilation, presence of pseudoexfoliation, history of diabetes, hypertension, and use of any A1AB will be recorded. Intraoperative adverse events such as pupillary constriction, iris billowing, and iris prolapse from the wound will be noted. Multinomial regression analysis will be used to evaluate the relationship of IFIS signs with pseudoexfoliation, diabetes, hypertension, and A1AB usage. According to the results we will determine the incidence of IFIS in our patient population and evaluate its relationship with alpha-1 adrenergic blocker use. We will also investigate the relationship of floppy iris problems with pseudoexfoliation, diabetes, high blood pressure.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 28 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with the diagnosis of cataract who were decided to have phacoemulsification
Key exclusion criteria (2 listed)
- Previous history of trauma or surgery of the eye, congenital ocular disease including cataract, infection, inflammation, angle closure glaucoma, or medication (topical) that might affect the size and shape of the pupil
- Only the first operated eye of each patient was included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2007.
- Background: PubMed 15899440Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. J Cataract Refract Surg. 2005 Apr;31(4):664-73. doi: 10.1016/j.jcrs.2005.02.027.
- Background: PubMed 16950249Schwinn DA, Afshari NA. alpha(1)-Adrenergic receptor antagonists and the iris: new mechanistic insights into floppy iris syndrome. Surv Ophthalmol. 2006 Sep-Oct;51(5):501-12. doi: 10.1016/j.survophthal.2006.06.011.
- Derived from this study: PubMed 19485285Altan-Yaycioglu R, Gedik S, Pelit A, Akova YA, Akman A. Clinical factors associated with floppy iris signs: a prospective study from two centers. Ophthalmic Surg Lasers Imaging. 2009 May-Jun;40(3):232-8. doi: 10.3928/15428877-20090430-02.
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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.
Rana Altan-Yaycioglu, MD study chair
Baskent University, Faculty of Medicine, Department of Ophthalmology
Yonca A Akova, MD study director
Baskent University, Faculty of Medicine, Department of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pupil Constriction and Iris Floppiness, run by Baskent University at 1 site in Turkey (Türkiye).
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 2 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: finished, as of the sponsor's last update on 14 May 2007. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00472888, which also lists 3 linked publications.
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 14 May 2007.