Trial Outcomes & Findings for Intraoperative Floppy Iris Syndrome (NCT NCT00711347)
NCT ID: NCT00711347
Last Updated: 2010-08-10
Results Overview
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.
COMPLETED
PHASE4
28 participants
1 month
2010-08-10
Participant Flow
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.
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.
Participant milestones
| Measure |
DisCoVisc
Alcon's DisCoVisc used at time of surgery
|
Healon5
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative Floppy Iris Syndrome
Baseline characteristics by cohort
| Measure |
DisCoVisc
n=14 Participants
Alcon's DisCoVisc used at time of surgery
|
Healon5
n=14 Participants
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: 14 patients/28 eyes in each group.
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.
Outcome measures
| Measure |
DisCoVisc
n=14 Participants
Alcon's DisCoVisc used at time of surgery
|
Healon5
n=14 Participants
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|---|---|---|
|
Corneal Endothelial Cell Loss
|
9.85 Percent change
Standard Deviation 14.07
|
-3.68 Percent change
Standard Deviation 16.52
|
SECONDARY outcome
Timeframe: 1 Day PostoperativePopulation: 14 patients/28 eyes in each group.
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.
Outcome measures
| Measure |
DisCoVisc
n=14 Participants
Alcon's DisCoVisc used at time of surgery
|
Healon5
n=14 Participants
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|---|---|---|
|
Intraocular Pressure (IOP)
|
16.93 mmHg
Standard Deviation 3.67
|
20.29 mmHg
Standard Deviation 11.19
|
SECONDARY outcome
Timeframe: 1 Day PostoperativePopulation: 14 patients/28 eyes in each group.
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
Outcome measures
| Measure |
DisCoVisc
n=14 Participants
Alcon's DisCoVisc used at time of surgery
|
Healon5
n=14 Participants
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|---|---|---|
|
Aqueous Signs - Cells
|
0.93 Units on a scale
Standard Deviation 1.00
|
1.14 Units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 1 Day PostoperativePopulation: 14 patients/28 eyes in each group.
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.
Outcome measures
| Measure |
DisCoVisc
n=14 Participants
Alcon's DisCoVisc used at time of surgery
|
Healon5
n=14 Participants
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|---|---|---|
|
Aqueous Signs - Flare
|
0.43 Units on a scale
Standard Deviation 0.51
|
0.69 Units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 1 Day PostoperativePopulation: 14 patients/28 eyes in each group.
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
Outcome measures
| Measure |
DisCoVisc
n=14 Participants
Alcon's DisCoVisc used at time of surgery
|
Healon5
n=14 Participants
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|---|---|---|
|
Aqueous Signs - Edema
|
0.57 Units on a scale
Standard Deviation 0.65
|
0.79 Units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Time of SurgerySurvey 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
Outcome measures
| Measure |
DisCoVisc
n=14 Participants
Alcon's DisCoVisc used at time of surgery
|
Healon5
n=14 Participants
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|---|---|---|
|
Surgeon Survey
Surgeon Survey: Overall Surgical Difficulty
|
1.9 Units on a scale
Standard Deviation 0.8
|
2.5 Units on a scale
Standard Deviation 0.9
|
|
Surgeon Survey
Surgeon Survey: Satisfaction with Performance
|
4.6 Units on a scale
Standard Deviation 0.5
|
3.6 Units on a scale
Standard Deviation 1.0
|
|
Surgeon Survey
Surgeon Survey: Ability to Expand Pupil
|
2.9 Units on a scale
Standard Deviation 0.4
|
2.9 Units on a scale
Standard Deviation 0.3
|
Adverse Events
DisCoVisc
Healon5
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
- Publication restrictions are in place
Restriction type: OTHER