Trial Outcomes & Findings for Clinical Evaluation of a New Viscoelastic for Cataract Surgery (NCT NCT00972621)

Results Overview

Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

400 participants

Primary outcome timeframe

3 months postoperative

Results posted on

2025-02-11

Participant Flow

Subjects were recruited from the general cataract populations from 11 ophthalmic practices between September 2009 and July 2010.

Enrolled participants who did not meet the inclusion/exclusion criteria as detailed in the protocol were excluded from the trial prior to assignment to study group. Randomization assigned199 Vitrax II subjects and 201 Viscoat subjects, but a randomization error (Viscoat (control) subject treated with Vitrax II) resulted in 200 subjects per group.

Participant milestones

Participant milestones
Measure	Vitrax II Investigational dispersive viscoelastic	Viscoat Currently marketed viscoelastic
Overall Study STARTED	200	200
Overall Study COMPLETED	200	199
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of a New Viscoelastic for Cataract Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitrax II n=200 Participants Investigational dispersive viscoelastic	Viscoat n=200 Participants Currently marketed viscoelastic	Total n=400 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	67 Participants n=5 Participants	54 Participants n=7 Participants	121 Participants n=5 Participants
Age, Categorical >=65 years	133 Participants n=5 Participants	146 Participants n=7 Participants	279 Participants n=5 Participants
Age, Continuous	68.0 years STANDARD_DEVIATION 8.88 • n=5 Participants	70.1 years STANDARD_DEVIATION 8.86 • n=7 Participants	69.03 years STANDARD_DEVIATION 8.92 • n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants	120 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	80 Participants n=7 Participants	153 Participants n=5 Participants
Region of Enrollment United States	200 participants n=5 Participants	200 participants n=7 Participants	400 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months postoperative

Population: Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting IOP spikes ≥ 30 mmHg for ITT population, which differs from the safety population used in the Participant Flow.

Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.

Outcome measures

Outcome measures
Measure	Vitrax II n=199 Participants Vitrax II: Investigational Treatment	Viscoat n=201 Participants Viscoat: Control Treatment
Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively	10.6 percentage of participants Interval 6.97 to 14.14	7.6 percentage of participants Interval 4.49 to 10.63

SECONDARY outcome

Timeframe: 3 months postoperative

Population: Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting mean endothelial cell count for ITT population, which differs from the safety population used in the Participant Flow.

mean endothelial cell count (measured by Konan specular microscope) at 3 months

Outcome measures

Outcome measures
Measure	Vitrax II n=199 Participants Vitrax II: Investigational Treatment	Viscoat n=201 Participants Viscoat: Control Treatment
Postoperative Mean Endothelial Cell Count	2454.3 number of endothelial cells Standard Deviation 28.87	2366.3 number of endothelial cells Standard Deviation 33.29

Adverse Events

Vitrax II

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Viscoat

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vitrax II n=200 participants at risk Investigational dispersive viscoelastic	Viscoat n=200 participants at risk Currently marketed viscoelastic
Eye disorders IOP Spike greater than or equal to 30 mm HG	10.5% 21/200 • Number of events 22	7.5% 15/200 • Number of events 16

Additional Information

Kendra Hileman, Ph.D., Head, Clinical Research & Development

Abbott Medical Optics, Inc.

Phone: 714-247-8613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At least ninety (90) days prior to any proposed submission for publication or presentation of Study Data or other findings related to the Study, Institution will provide Sponsor with a manuscript of such submission(s) for review, comment, and approval.
Publication restrictions are in place

Restriction type: OTHER