Intraoperative Floppy Iris Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00711347

Enrollment

Registered

2008-07-08

Start date

2007-06-30

Completion date

2008-04-30

Last updated

2010-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Floppy Iris Syndrome

Keywords

Discovisc, Ophthalmic Visco Surgical Device

Brief 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.

Interventions

DEVICEDisCoVisc

Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation.

DEVICEHealon5

Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Corneal Endothelial Cell Loss	1 month	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.

Secondary

Measure	Time frame	Description
Intraocular Pressure (IOP)	1 Day Postoperative	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.
Aqueous Signs - Cells	1 Day Postoperative	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
Aqueous Signs - Flare	1 Day Postoperative	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. 1. Mild-Flare visible against dark papillary background but not visible against iris background. 2. Moderate-flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background. 3. 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.
Aqueous Signs - Edema	1 Day Postoperative	Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none 1. = mild - slight localized or generalized edema 2. = moderate - significant localized or generalized edema 3. = severe - advanced localized or generalized edema
Surgeon Survey	Time of Surgery	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

Countries

United States

Participant flow

Recruitment details

Patients were scheduled for routine, primary, bilateral cataract extraction with subsequent insertion of an intraocular lens implant and demonstrating miotic/small pupils or intraoperative floppy iris syndrome. Additionally patients were free of ocular co-morbidities that may affect results.

Pre-assignment details

During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. Patients were randomized (Excel based schedule) based on enrollment order.

Participants by arm

Arm	Count
DisCoVisc Alcon's DisCoVisc used at time of surgery	14
Healon5 Abbot Medical Optics (AMO) Healon5 used at time of surgery	14
Total	28

Baseline characteristics

Characteristic	DisCoVisc	Healon5	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	13 Participants	13 Participants	26 Participants
Age, Categorical Between 18 and 65 years	1 Participants	1 Participants	2 Participants
Sex: Female, Male Female	1 Participants	2 Participants	3 Participants
Sex: Female, Male Male	13 Participants	12 Participants	25 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 14	0 / 14
serious Total, serious adverse events	0 / 14	0 / 14

Outcome results

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.

Time frame: 1 month