Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract

Keywords

cataractaspherical intraocular lensesfunctional vision

Outcome Measures

Primary Outcomes (2)

Best Corrected logMAR Contrast Acuity at Photopic/Mesopic Condition
Contrast acuity testing was measured with spectacle correction for the target distance of three meters using a logMAR letter chart (Precision Vision®) represented on a wall-mounted illuminator cabinet. Two types of contrast charts were used, high contrast (Cat.No.2103 SLOAN translucent chart) and low contrast (Cat.No.2132 10% SLOAN translucent chart), and these were tested under both photopic (250 Lux) and mesopic (0.5 Lux) conditions. The contrast acuity tested ranges from 20/160 to 20/20(from worse to best), which equals LogMAR(Logarithm of the Minimum Angle of Resolution)0.9 to -0.3. All of the visual acuity and functional vision testing examinations mentioned above were performed by a single ophthalmologist. The outcomes were recorded as average of three post-operative measurments.
average data of post-op 3rd, 6th, 12th week measurements
Best Corrected Contrast Sensitivity in Photopic Condition
Contrast sensitivity testing was measured with spectacle correction for the target distance of three meters using a wall-mounted FACT sine-wave grating chart with nine levels of contrast (Stereo Optical Inc.)and five spatial frequency targets (1.5, 3, 6, 12, 18 cycles per degree (cpd)) at 250 lux. The last correct grating seen for each spatial frequency is recorded and translated by the "EYEVIEW™ Functional Analysis Software" into a log contrast sensitivity unit. The outcomes were recorded as average of the three post-operative measurements. ( physiological range of contrast sensitivity: 1.5 cpd : 25\~82.5 ; 3 cpd: 30\~150 ; 6 cpd: 65 \~ 200 ; 12 cpd: 20 \~130 ; 18 cpd: 6.5 \~ 65 )
average data of post-operative 3rd week, 6th week, 12th week measurements

Secondary Outcomes (2)

Corneal High-order Aberrations
pre-op & averate data of post-op 3rd, 6th, 12th week measurements
Total Ocular High-order Aberrations
average data of post-op 3rd, 6th, 12th week measurements

Study Arms (1)

intraocular lens

ACTIVE COMPARATOR

patients with bilateral clinical significant cataract reisiceved cataract surgeries and recieved spherial intraocuar lens(SA60AT, Alcon) in one eye and aspherical intraocular lens(Tecnis Z9000, AMO)in the other respectively.

Device: aspherical intraocular lensDevice: spherical intraocular lens

Interventions

aspherical intraocular lensDevice

implantation of aspherical intraocular lenses(AMO Tecnis Z9000)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

Also known as: AMO Tecnis Z9000

intraocular lens

spherical intraocular lensDevice

implantation of spherical intraocular lenses(Alcon SA60AT Acrysof)during cataract suregry (small cornea incision phacoemulsification, deliver with Monarch II device, in the bag implantation)

Eligibility Criteria

Age45 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Bilateral cataracts, eligible for phacoemulsification with primary implantation of a posterior chamber IOL
Willing and able to comply with scheduled visits and other study procedures

You may not qualify if:

Sponsors & Collaborators

National Taiwan University Hospital
Otherlead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Limitations and Caveats

small sample size

Results Point of Contact

Title: Fung-Rong Hu
Organization: National Taiwan University Hospital

Study Officials

Pei-Yuang Su, MD
National Taiwan Unoversity Hospital
PRINCIPAL INVESTIGATOR
Fung-Rong Hu, MD
National Taiwan University Hospital
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NA
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 10, 2007

First Posted

April 11, 2007

Study Start

October 2005

Date type not reported

This date has not been verified as actual or estimated.

Comparison of Functional Vision Provided by AMO Tecnis Z9000 and Alcon SA60AT Acrysof

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

intraocular lens

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (1)

intraocular lens

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations