Intraoperative Floppy Iris Syndrome

Cataract Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711347
• Other study ID #: M07-013
• Status: Completed
• Phase: Phase 4
• First received: July 3, 2008
• Last updated: August 4, 2010
• Start date: June 2007
• Est. completion date: April 2008

Study information

• Verified date: August 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosed with floppy iris syndrome

• operable bilateral cataracts

Exclusion Criteria:

• Intraocular Pressure (IOP) > 21mmHg

• ocular inflammatory disease

• systemic or ocular diseases affecting Endothelial Cell Count

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Floppy Iris Syndrome

Intervention

Device:
• DisCoVisc
Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.
• Healon5
Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Study Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Endothelial Cell Loss	Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells.	1 month	Yes
Secondary	Intraocular Pressure (IOP)	Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg.	1 Day Postoperative	Yes
Secondary	Aqueous Signs - Cells	Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells	1 Day Postoperative	Yes
Secondary	Aqueous Signs - Flare	Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale: 0:No-Visible flare when compared with the normal eye.; Mild-Flare visible against dark papillary background but not visible against iris background.; Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background.; Severe-Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp.	1 Day Postoperative	Yes
Secondary	Aqueous Signs - Edema	Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none; = mild - slight localized or generalized edema; = moderate - significant localized or generalized edema; = severe - advanced localized or generalized edema	1 Day Postoperative	Yes
Secondary	Surgeon Survey	Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported: Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult; Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree; Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective	Time of Surgery	No