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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.

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00763360
Enrollment
184
Registered
2008-09-30
Start date
2008-05-31
Completion date
Unknown
Last updated
2012-01-24

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

Conditions

Cataract

Keywords

Cataract

Brief summary

The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.

Interventions

DEVICEDisCoVisc®

Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure

DRUGHealon

Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure

DRUGAmvisc Plus

Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
49 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients able to understand and sign a document of informed consent; * Patients aged ≥49 years with age-related cataract formation; * Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens; * Patients that have healthy eyes excluding the formation of cataract.

Exclusion criteria

* pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye; * A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye; * Iris atrophy in the operative eye; * Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye; * Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye; * Ocular hypertension (lntraocular Pressure (IOP) \> 21 mmHg) in the operative eye at the baseline exam; * Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement; * Baseline endothelial cell density \< 1500 cells/mm2, in the operative eye; * Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy * Patients 48 years of age or younger; * Proliferative diabetic retinopathy in the operative eye; * Uncontrolled diabetes mellitus; * Marfan's Syndrome; * An ocular disease and/or condition that may compromise results; * A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye; * Lens for the correction of astigmatism may be performed; * Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion; * A non-functional fellow eye; * Participation in any other clinical study within the 30 days before surgery

Design outcomes

Primary

MeasureTime frameDescription
Endothelial Cell Count Change From Baselineone monthChange in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
Investigator Reported Space MaintenanceDuring surgical procedureMaintenance 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.

Secondary

MeasureTime frameDescription
Change in Corneal Thickness1 monthChange in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.
Corneal Clarity2 weeksEvaluation 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.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

Patients were screened prior to cataract operation

Participants by arm

ArmCount
DisCoVisc®
DisCoVisc® Ophthalmic Viscosurgical Device
61
Healon
Healon
60
Amvisc Plus
Amvisc Plus
63
Total184

Baseline characteristics

CharacteristicDisCoVisc®HealonAmvisc PlusTotal
Age Continuous73.97 years
STANDARD_DEVIATION 9.03
75.56 years
STANDARD_DEVIATION 7.6
75.51 years
STANDARD_DEVIATION 8.49
75.01 years
STANDARD_DEVIATION 8.39
Sex: Female, Male
Female
34 Participants40 Participants43 Participants117 Participants
Sex: Female, Male
Male
27 Participants20 Participants20 Participants67 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 610 / 600 / 63
serious
Total, serious adverse events
0 / 610 / 600 / 63

Outcome results

Primary

Endothelial Cell Count Change From Baseline

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

Time frame: one month

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

ArmMeasureValue (MEAN)Dispersion
DisCoVisc®Endothelial Cell Count Change From Baseline-7.91 Percent change from baselineStandard Deviation 16.49
HealonEndothelial Cell Count Change From Baseline-5.11 Percent change from baselineStandard Deviation 19.41
Amvisc PlusEndothelial Cell Count Change From Baseline-4.92 Percent change from baselineStandard Deviation 13.89
Primary

Investigator Reported Space Maintenance

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.

Time frame: During surgical procedure

ArmMeasureGroupValue (NUMBER)
DisCoVisc®Investigator Reported Space MaintenancePhacoemulsification - shallow0 participants
DisCoVisc®Investigator Reported Space MaintenanceHydrodissection - working space maintained8 participants
DisCoVisc®Investigator Reported Space MaintenanceCapsulorhexis - full chamber maintained59 participants
DisCoVisc®Investigator Reported Space MaintenancePhacoemulsification - working space maintained2 participants
DisCoVisc®Investigator Reported Space MaintenanceHydrodissection - shallow1 participants
DisCoVisc®Investigator Reported Space MaintenanceIOL insertion - working space maintained2 participants
DisCoVisc®Investigator Reported Space MaintenancePhacoemulsification - full chamber maintained59 participants
DisCoVisc®Investigator Reported Space MaintenanceHydrodissection - flat0 participants
DisCoVisc®Investigator Reported Space MaintenanceCapsulorhexis - shallow0 participants
DisCoVisc®Investigator Reported Space MaintenanceIOL insertion - flat0 participants
DisCoVisc®Investigator Reported Space MaintenanceIOL insertion - full chamber maintained59 participants
DisCoVisc®Investigator Reported Space MaintenanceCapsulorhexis - flat0 participants
DisCoVisc®Investigator Reported Space MaintenanceIOL insertion - shallow0 participants
DisCoVisc®Investigator Reported Space MaintenancePhacoemulsification - flat0 participants
DisCoVisc®Investigator Reported Space MaintenanceHydrodissection - full chamber maintained52 participants
DisCoVisc®Investigator Reported Space MaintenanceCapsulorhexis - working space maintained2 participants
HealonInvestigator Reported Space MaintenanceCapsulorhexis - flat1 participants
HealonInvestigator Reported Space MaintenanceCapsulorhexis - full chamber maintained26 participants
HealonInvestigator Reported Space MaintenanceCapsulorhexis - working space maintained26 participants
HealonInvestigator Reported Space MaintenanceCapsulorhexis - shallow5 participants
HealonInvestigator Reported Space MaintenanceHydrodissection - flat10 participants
HealonInvestigator Reported Space MaintenanceHydrodissection - full chamber maintained10 participants
HealonInvestigator Reported Space MaintenanceHydrodissection - working space maintained22 participants
HealonInvestigator Reported Space MaintenanceHydrodissection - shallow16 participants
HealonInvestigator Reported Space MaintenancePhacoemulsification - full chamber maintained55 participants
HealonInvestigator Reported Space MaintenancePhacoemulsification - working space maintained3 participants
HealonInvestigator Reported Space MaintenancePhacoemulsification - shallow0 participants
HealonInvestigator Reported Space MaintenancePhacoemulsification - flat0 participants
HealonInvestigator Reported Space MaintenanceIOL insertion - full chamber maintained48 participants
HealonInvestigator Reported Space MaintenanceIOL insertion - working space maintained8 participants
HealonInvestigator Reported Space MaintenanceIOL insertion - shallow1 participants
HealonInvestigator Reported Space MaintenanceIOL insertion - flat1 participants
Amvisc PlusInvestigator Reported Space MaintenancePhacoemulsification - shallow0 participants
Amvisc PlusInvestigator Reported Space MaintenanceCapsulorhexis - flat0 participants
Amvisc PlusInvestigator Reported Space MaintenanceIOL insertion - flat0 participants
Amvisc PlusInvestigator Reported Space MaintenancePhacoemulsification - flat0 participants
Amvisc PlusInvestigator Reported Space MaintenanceCapsulorhexis - shallow1 participants
Amvisc PlusInvestigator Reported Space MaintenanceIOL insertion - shallow0 participants
Amvisc PlusInvestigator Reported Space MaintenanceIOL insertion - full chamber maintained63 participants
Amvisc PlusInvestigator Reported Space MaintenanceCapsulorhexis - working space maintained1 participants
Amvisc PlusInvestigator Reported Space MaintenanceHydrodissection - shallow6 participants
Amvisc PlusInvestigator Reported Space MaintenanceHydrodissection - flat2 participants
Amvisc PlusInvestigator Reported Space MaintenancePhacoemulsification - full chamber maintained62 participants
Amvisc PlusInvestigator Reported Space MaintenanceHydrodissection - working space maintained10 participants
Amvisc PlusInvestigator Reported Space MaintenanceIOL insertion - working space maintained0 participants
Amvisc PlusInvestigator Reported Space MaintenancePhacoemulsification - working space maintained1 participants
Amvisc PlusInvestigator Reported Space MaintenanceHydrodissection - full chamber maintained45 participants
Amvisc PlusInvestigator Reported Space MaintenanceCapsulorhexis - full chamber maintained61 participants
Secondary

Change in Corneal Thickness

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

Time frame: 1 month

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

ArmMeasureValue (MEDIAN)Dispersion
DisCoVisc®Change in Corneal Thickness0.53 millimetersStandard Deviation 0.04
HealonChange in Corneal Thickness0.54 millimetersStandard Deviation 0.04
Amvisc PlusChange in Corneal Thickness0.53 millimetersStandard Deviation 0.04
Secondary

Corneal Clarity

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.

Time frame: 2 weeks

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

ArmMeasureGroupValue (NUMBER)
DisCoVisc®Corneal ClarityAqueous flare - moderate6 units on a scale
DisCoVisc®Corneal ClarityAqueous cells - cells frozen0 units on a scale
DisCoVisc®Corneal ClarityAqueous flare - severe0 units on a scale
DisCoVisc®Corneal ClarityAqueous cells - too many cells to count16 units on a scale
DisCoVisc®Corneal ClarityAqueous cells - no cells0 units on a scale
DisCoVisc®Corneal ClarityAqueous flare - mild53 units on a scale
DisCoVisc®Corneal ClarityAqueous cells - 1-10 cells10 units on a scale
DisCoVisc®Corneal ClarityAqueous flare - no visible flare2 units on a scale
DisCoVisc®Corneal ClarityAqueous cells - 10-50 cells34 units on a scale
HealonCorneal ClarityAqueous flare - mild54 units on a scale
HealonCorneal ClarityAqueous cells - 10-50 cells37 units on a scale
HealonCorneal ClarityAqueous cells - too many cells to count15 units on a scale
HealonCorneal ClarityAqueous cells - cells frozen0 units on a scale
HealonCorneal ClarityAqueous cells - no cells0 units on a scale
HealonCorneal ClarityAqueous flare - moderate4 units on a scale
HealonCorneal ClarityAqueous flare - no visible flare2 units on a scale
HealonCorneal ClarityAqueous flare - severe0 units on a scale
HealonCorneal ClarityAqueous cells - 1-10 cells8 units on a scale
Amvisc PlusCorneal ClarityAqueous cells - cells frozen0 units on a scale
Amvisc PlusCorneal ClarityAqueous flare - no visible flare1 units on a scale
Amvisc PlusCorneal ClarityAqueous flare - mild59 units on a scale
Amvisc PlusCorneal ClarityAqueous flare - moderate3 units on a scale
Amvisc PlusCorneal ClarityAqueous flare - severe0 units on a scale
Amvisc PlusCorneal ClarityAqueous cells - no cells0 units on a scale
Amvisc PlusCorneal ClarityAqueous cells - 1-10 cells11 units on a scale
Amvisc PlusCorneal ClarityAqueous cells - 10-50 cells37 units on a scale
Amvisc PlusCorneal ClarityAqueous cells - too many cells to count15 units on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026