Trial Outcomes & Findings for To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery. (NCT NCT00763360)

Last Updated: 2012-01-24

Results Overview

Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

184 participants

Primary outcome timeframe

one month

Results posted on

2012-01-24

Participant Flow

Patients were undergoing a cataract operation and were recruited from surgery during 2008 to 2010

Patients were screened prior to cataract operation

Participant milestones

Participant milestones
Measure	DisCoVisc® DisCoVisc® Ophthalmic Viscosurgical Device	Healon Healon	Amvisc Plus Amvisc Plus
Overall Study STARTED	61	60	63
Overall Study COMPLETED	61	58	63
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DisCoVisc® n=61 Participants DisCoVisc® Ophthalmic Viscosurgical Device	Healon n=60 Participants Healon	Amvisc Plus n=63 Participants Amvisc Plus	Total n=184 Participants Total of all reporting groups
Age Continuous	73.97 years STANDARD_DEVIATION 9.03 • n=5 Participants	75.56 years STANDARD_DEVIATION 7.6 • n=7 Participants	75.51 years STANDARD_DEVIATION 8.49 • n=5 Participants	75.01 years STANDARD_DEVIATION 8.39 • n=4 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	40 Participants n=7 Participants	43 Participants n=5 Participants	117 Participants n=4 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	67 Participants n=4 Participants

PRIMARY outcome

Timeframe: one month

Population: Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis.

Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.

Outcome measures

Outcome measures
Measure	DisCoVisc® n=57 Participants DisCoVisc® Ophthalmic Viscosurgical Device	Healon n=58 Participants Healon	Amvisc Plus n=61 Participants Amvisc Plus
Endothelial Cell Count Change From Baseline	-7.91 Percent change from baseline Standard Deviation 16.49	-5.11 Percent change from baseline Standard Deviation 19.41	-4.92 Percent change from baseline Standard Deviation 13.89

PRIMARY outcome

Timeframe: During surgical procedure

Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.

Outcome measures

Outcome measures
Measure	DisCoVisc® n=61 Participants DisCoVisc® Ophthalmic Viscosurgical Device	Healon n=58 Participants Healon	Amvisc Plus n=61 Participants Amvisc Plus
Investigator Reported Space Maintenance Capsulorhexis - flat	0 participants	1 participants	0 participants
Investigator Reported Space Maintenance Hydrodissection - full chamber maintained	52 participants	10 participants	45 participants
Investigator Reported Space Maintenance Hydrodissection - working space maintained	8 participants	22 participants	10 participants
Investigator Reported Space Maintenance Capsulorhexis - full chamber maintained	59 participants	26 participants	61 participants
Investigator Reported Space Maintenance Capsulorhexis - working space maintained	2 participants	26 participants	1 participants
Investigator Reported Space Maintenance Capsulorhexis - shallow	0 participants	5 participants	1 participants
Investigator Reported Space Maintenance Hydrodissection - shallow	1 participants	16 participants	6 participants
Investigator Reported Space Maintenance Hydrodissection - flat	0 participants	10 participants	2 participants
Investigator Reported Space Maintenance Phacoemulsification - full chamber maintained	59 participants	55 participants	62 participants
Investigator Reported Space Maintenance Phacoemulsification - working space maintained	2 participants	3 participants	1 participants
Investigator Reported Space Maintenance Phacoemulsification - shallow	0 participants	0 participants	0 participants
Investigator Reported Space Maintenance Phacoemulsification - flat	0 participants	0 participants	0 participants
Investigator Reported Space Maintenance IOL insertion - full chamber maintained	59 participants	48 participants	63 participants
Investigator Reported Space Maintenance IOL insertion - working space maintained	2 participants	8 participants	0 participants
Investigator Reported Space Maintenance IOL insertion - shallow	0 participants	1 participants	0 participants
Investigator Reported Space Maintenance IOL insertion - flat	0 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: 1 month

Population: Subjects that did not have both baseline and 1 month values were not included in this analysis.

Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.

Outcome measures

Outcome measures
Measure	DisCoVisc® n=57 Participants DisCoVisc® Ophthalmic Viscosurgical Device	Healon n=57 Participants Healon	Amvisc Plus n=61 Participants Amvisc Plus
Change in Corneal Thickness	0.53 millimeters Standard Deviation 0.04	0.54 millimeters Standard Deviation 0.04	0.53 millimeters Standard Deviation 0.04

SECONDARY outcome

Timeframe: 2 weeks

Population: Data from subjects for whom this evaluation was not performed is not included in this analysis.

Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.

Outcome measures

Outcome measures
Measure	DisCoVisc® n=61 Participants DisCoVisc® Ophthalmic Viscosurgical Device	Healon n=58 Participants Healon	Amvisc Plus n=63 Participants Amvisc Plus
Corneal Clarity Aqueous flare - no visible flare	2 units on a scale	2 units on a scale	1 units on a scale
Corneal Clarity Aqueous flare - mild	53 units on a scale	54 units on a scale	59 units on a scale
Corneal Clarity Aqueous flare - moderate	6 units on a scale	4 units on a scale	3 units on a scale
Corneal Clarity Aqueous flare - severe	0 units on a scale	0 units on a scale	0 units on a scale
Corneal Clarity Aqueous cells - no cells	0 units on a scale	0 units on a scale	0 units on a scale
Corneal Clarity Aqueous cells - 1-10 cells	10 units on a scale	8 units on a scale	11 units on a scale
Corneal Clarity Aqueous cells - 10-50 cells	34 units on a scale	37 units on a scale	37 units on a scale
Corneal Clarity Aqueous cells - too many cells to count	16 units on a scale	15 units on a scale	15 units on a scale
Corneal Clarity Aqueous cells - cells frozen	0 units on a scale	0 units on a scale	0 units on a scale

Adverse Events

DisCoVisc®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amvisc Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place